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Item 1. Business

2023-03-01 compared with 2022-02-25 · 191 added, 202 removed, 396 unchanged (50% of the section changed)

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We provide insights that help people take control of their health and enable healthcare providers to better detect, treat, and prevent disease.

We discover and commercialize genetic tests that determine the risk of developing disease, assess the risk of disease progression, or guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower health care costs.

Change in Fiscal Year

Effective January 1, 2021, we changed our fiscal year end from the last day of June to a calendar fiscal year.

Our calendar fiscal year commenced on January 1, 2021 and ended on December 31, 2021.

The six month period that commenced on July 1, 2020 and ended on December 31, 2020 was a transition period (the "transition period").

In this Annual Report, references to “fiscal year” refer to years ended June 30th or December 31st, as applicable.

References in this report to the “transition period" refer to the six-month period ended December 31, 2020.

Business Updates

During the year ended December 31, 2021, we took meaningful steps to fulfill our mission and execute our strategic transformation and growth plan.

Our announcements in 2021 included the following:

• Launched a new version of the MyRisk Hereditary Cancer Test with RiskScore, which allows, for the first time, women of all ancestries to receive a personalized polygenic breast cancer risk assessment.

• Entered into a collaboration with Illumina, Inc.

("Illumina") and Intermountain Precision Genomics for a comprehensive offering of germline and somatic tumor testing services.

The strategic collaboration combines germline genetic testing, next-generation tumor sequencing and world-class testing capabilities to improve precision oncology care.

• Completed the sales of Myriad RBM, Inc., select operating assets and intellectual property, including the Vectra® test, from the Myriad Autoimmune business unit, and the Myriad myPath, LLC laboratory.

• Announced the hiring of several new Company leaders, including a new Chief Growth Officer, Diversity, Equity and Inclusion Leader, Chief Medical Officer, and Chief Legal Officer, as well as the new appointment of our Chief Marketing Officer, Chief Technology Officer, President of Myriad Oncology, President of Myriad Women's Health and Chief Operating Officer.

In January 2022, we also announced the retirement of our Chief Scientific Officer.

• Peer-reviewed journal Psychiatry Research published a new analysis showing that the combinatorial approach available in the GeneSight® Psychotropic test is better than single-gene testing at predicting patient outcomes and medication blood levels.

• Presented new data at the American Society of Clinical Oncology Genitourinary Conference demonstrating that the Prolaris test can accurately predict which patients will benefit from multi-modality therapy.

Using the newly established threshold, an estimated 27% of men with newly diagnosed high-risk disease and 73% with unfavorable intermediate-risk disease could avoid multi-modality therapy.

• Received the first reimbursement decision for MyChoice® Diagnostic System in Japan, enabling women with ovarian cancer to benefit from treatment with the PARP inhibitor Zejula® (niraparib).

MyChoice is the only companion diagnostic test of its kind to be approved for reimbursement in Japan.

We develop and offer tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower health care costs.

Our Business Strategy

Personalized genetic data, digital, and virtual consumer trends are converging to change traditional models of care.

Significant growth opportunities exist to help patient populations with pressing health care needs through innovative solutions and services.

We are currently executing a strategic transformation and growth plan that aims to capitalize on those trends by focusing on the following strategic priorities:

• Innovation that improves clinical outcomes, ease of use, and access;

• Enterprise capabilities to accelerate growth and scale to market opportunity;

• Focus on execution and delivery of consistent results.

In connection with these strategic priorities, we are focusing our efforts in three key areas where we have specialized products, capabilities, and expertise:

We believe significant growth opportunities exist to help patient populations with pressing health care needs through innovative genetic and precision medicine solutions and services.

Our focus is on organic growth, deployment of capital, including through opportunistic acquisitions, and the launch of new products.

We are focusing our efforts in three key areas where we have specialized products, capabilities, and expertise:

Oncology, Women's Health, and Mental Health.

In each of these areas, we intend to develop and enhance best-in-class products to support growth, improve patient and provider experience, and reach more patients of all backgrounds.

By investing in tech-enabled commercial tools, we believe we will be able to drive increased engagement, improve revenue cycle management, and reduce complexity and cost.

We believe our path to organic growth is driven by articulating our clinical differentiation, advancing a new commercial model in our Oncology and Women's Health businesses to reach a broader set of physicians and patients, raising awareness with patients who we believe would benefit from testing, and innovation that improves clinical outcomes, ease of use, and access.

By investing in tech-enabled commercial tools, new laboratory facilities, and advanced automation, we believe we will be able to reduce complexity and cost.

With a foundation of financial, commercial, operational, and technological strength, we plan to launch new products and capabilities in 2023, such as our unified ordering portal, FirstGene, and, on a research use only basis, Precise minimal residual disease (MRD), which we expect will help accelerate our growth.

We intend to develop and enhance our products to support growth, improve patient and provider experience, and reach more patients of all backgrounds.

We are committed to disciplined management of a key set of initiatives to fulfill our mission and drive long-term growth and profitability.

With a foundation of financial, commercial, operational and technological strength, we expect to accelerate growth as we launch a new enterprise commercial model, launch a unified ordering portal, invest in new sequencing technologies, further develop direct-to-consumer channels, and build commercial capabilities to support new products and offerings.

Molecular Diagnostic Testing

Our molecular diagnostic tests are designed to analyze genes and their expression levels to assess an individual’s risk for developing disease, determine a patient’s likelihood of responding to a particular drug, or assess a patient’s risk of disease progression.

Genetic testing for cancer patients and companion diagnostic tests that work with corresponding drugs and treatments.

Our tests are designed to analyze genes and their expression levels to assess an individual’s risk for developing disease, determine a patient’s likelihood of responding to a particular drug, assess a patient’s risk of disease progression, or identify factors which could lead to serious conditions in pregnancy.

We focus our efforts in the following three key areas where we have specialized products, capabilities, and expertise:

Clarifying cancer treatment with genetic insights and companion diagnostic tests that are designed to work with corresponding drugs and treatments.

Women's Health:

Serves women of all ancestries, assesses risk of cancer, and offers prenatal testing solutions.

Providing genetic insights for women of all ancestries, assessing cancer risk, and offering prenatal testing solutions.

Mental Health:

Genetic testing to help physicians understand how genetic alterations impact patient response to anti-depressants and other drugs.

The following tests are included in the respective key areas outlined above:

Providing genetic insights to help physicians understand how genetic alterations impact patient response to anti-depressants and other drugs.

The following tests are included in the key areas outlined above:

Oncology Women's Health Mental Health

MyRisk MyRisk GeneSight

Precise Tumor Prequel

BRACAnalysis CDx Prequel

MyChoice CDx Foresight

BRACAnalysis CDx

Prolaris SneakPeek

Precise Tumor

Descriptions of our tests are as follows:

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MyRisk also includes RiskScore ® for all ancestries.

RiskScore ® incorporates the patient’s own clinical risk factors, family history, and unique genetic, ancestry-informed breast cancer risk markers and provides a personalized five-year and lifetime risk of developing breast cancer—regardless of ancestry.

RiskScore incorporates the patient’s own clinical risk factors, family history, and unique genetic, ancestry-informed breast cancer risk markers and provides a personalized five-year and lifetime assessment of the risk of developing breast cancer—regardless of ancestry.

BRACAnalysis CDx ® Germline Companion Diagnostic Test:

DNA sequencing test to help determine the most beneficial therapy for patients with metastatic breast, ovarian, metastatic pancreatic, or metastatic prostate cancer with deleterious or suspected deleterious germline BRCA variants.

Results of the test are used as an aid to identify patents who are eligible for treatment with U.S.

Results of our BRACAnalysis CDx test are used as an aid to identify patients who are eligible for treatment with U.S.

Food and Drug Administration (FDA) approved poly-ADP ribose polymerase (PARP) inhibitors.

This is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA).

Currently, we are the only laboratory with an FDA-approved test for this indication and have received approvals from the FDA in ovarian cancer, metastatic breast cancer, pancreatic cancer, and advanced prostate cancer.

The test is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA).

MyChoice ® CDx Companion Diagnostic Test:

the most comprehensive tumor test that determines homologous recombination deficiency (HRD) status in patients with ovarian cancer.

tumor test that determines homologous recombination deficiency (HRD) status in patients with ovarian cancer.

This FDA-approved test helps provide information on the magnitude of benefit for PARP inhibitor therapy.

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BRCA1 and BRCA2 status that encompasses sequence variants and large rearrangements, and Genomic Instability Status (GIS) encompassing loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions across the entire genome.

The combination of these methods is a more comprehensive way to measure HRD status, versus either one alone.

We believe that the combination of these methods is a more comprehensive way to measure HRD status, versus either one alone.

Prolaris ® Prostate Cancer Prognostic Test:

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EndoPredict has been shown to accurately predict risk of distant recurrence in Her 2-, ER+, node negative, and node positive breast cancer patients with no confusing intermediate results in 13 published clinical studies with more than 2,200 patients and is Conformitè Europëenne (CE) marked, which signifies European certification for clinical use.

Precise™ Tumor :

a comprehensive solution for advanced precision oncology .

Precise™ Oncology Solutions, which we expect to launch in the first quarter of 2022, combines our leading germline hereditary cancer test (MyRisk/BRACAnalysis CDx), our HRD companion diagnostic test (MyChoice CDx), and a comprehensive genetic tumor panel powered by Intermountain Precision Genomics, a service of Intermountain Healthcare.

Precise Oncology Solutions will help providers determine a clear, integrated and personalized treatment plan for patients with cancer.

Precise™ Tumor Molecular Profile Test:

a tumor profile test offered as part of Precise™ Oncology Solutions, a comprehensive solution for advanced precision oncology .

Precise ™ Oncology Solutions combines our leading germline hereditary cancer tests (MyRisk/BRACAnalysis CDx), our HRD companion diagnostic test (MyChoice CDx), and a comprehensive genetic tumor panel performed by Intermountain Precision Genomics, a service of Intermountain Healthcare.

We believe Precise Oncology Solutions will help providers determine a clear, integrated, and personalized treatment plan for patients with cancer.

Prequel ® Prenatal Screen:

a non-invasive prenatal screening (NIPS) test conducted using maternal blood to screen for severe chromosomal disorders in a fetus.

The screening test uses whole genome sequencing to assess for trisomies and monosomies in all 23 chromosomal pairs including the sex chromosomes, along with microdeletions associated with common genetic diseases.

The Prequel test uses whole genome sequencing to assess for trisomies and monosomies in all 23 chromosomal pairs including the sex chromosomes, along with microdeletions associated with common genetic diseases.

Prequel has a low test failure rate at less than 1 in 1,000 patients and has been validated in multiple clinical studies to be highly accurate.

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a prenatal test for future parents to assess their risk of passing on a recessive genetic condition to their offspring.

The test screens for carrier status of up to 175 serious and clinically actionable conditions in parents.

The Foresight test screens for carrier status of up to 176 genes associated with serious and prevalent inherited conditions.

The test has been shown to have a detection rate of 99% across all ethnicities.

Studies have shown that with prior knowledge of recessive genetic conditions, 76% of patients took preventive actions such as in-vitro fertilization with pre-implantation genetic testing to reduce the risk of having an affected offspring.

SneakPeek ® Early Gender DNA Test:

a non-invasive blood test that predicts the gender of a fetus as early as six weeks.

Innovative cell free DNA technology and precise algorithms in the SneakPeek test are used to screen for a single, Y chromosome marker in the material blood sample.

If Y chromosome markers are found in the mother's blood, the baby is male.

If no Y chromosome markers are detected, the baby is female.

The SneakPeek test is able to determine fetal sex as early as six weeks of gestation with 99% accuracy.

GeneSight ® Psychotropic Mental Health Medication Test:

DNA genotyping test to aid psychotropic drug selection for patients suffering from depression, anxiety, ADHD and other mental health conditions.

DNA genotyping test to aid psychotropic drug selection for patients suffering from depression, anxiety, attention-deficit/hyperactivity disorder (ADHD) and other mental health conditions.

The GeneSight test provides healthcare professionals with information about which medications may require dose adjustments, may be less likely to work for a patient, or may have an increased risk of side effects based on a patient's genetic makeup.

Genesight ® covers 61 medications commonly prescribed for depression, anxiety, ADHD, and psychiatric conditions.

Genesight covers 64 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions.

Because genes influence the way a person’s body responds to specific medications, the medications may work differently for each person.

Using DNA gathered with a simple cheek swab, the GeneSight test analyzes a patient’s genes and provides individualized information to help healthcare providers select medications that better match the patient’s genetic variations.

Multiple clinical studies have shown that when clinicians used the GeneSight test to help guide treatment decisions, patients were more likely to respond to treatment compared to standard of care.

Multiple clinical studies have shown that when clinicians used the GeneSight test to help guide treatment decisions in major depressive disorders, patients were more likely to respond to treatment compared to standard of care.

Sales and Marketing

We sell our tests through our own direct sales force and marketing efforts in the United States, France, Germany and Japan, and service additional global accounts through indirect sales channels.

Our United States sales force is comprised of approximately 500 individuals across our dedicated sales channels.

Our inside sales team focuses on a broader base of leads, freeing up the field sales team to target high potential, high revenue clinical leads.

We sell our tests primarily through our own sales force and marketing efforts in the United States, Japan, Germany, and France, and we service additional global accounts through indirect sales channels.

sales force is comprised of approximately 500 individuals across our dedicated sales channels.

We continue to optimize our sales and marketing channels through increased digital marketing, direct to patient marketing, enhanced virtual sales tools, and inside sales teams to drive efficiency in our sales model.

As we elevate our existing products to their full potential and further differentiate our products, we intend to increase awareness and access while we reinforce clinical utility data, and maximize cross-selling and synergies across the enterprise.

For example, in 2022, we focused more on digital engagement and inside sales with our GeneSight test, which contributed to 36% year-over-year growth in product revenue.

Our inside sales team focuses on a broader base of leads, freeing up the field sales team to target high potential clinical leads.

We plan to integrate elements of this new sales and marketing model into our Women's Health channels and eventually into our other product lines, which we believe can be more cost effective in terms of customer acquisition costs.

Additionally, our recent acquisition of Gateway Genomics, LLC (Gateway), which offers a home-test prenatal kit, may provide us with greater direct to consumer access and create opportunities to cross-sell our other Women's Health products.

We believe we will be better able to execute on our strategies and fulfill our mission by engaging with providers and patients in new ways.

Research and Development

Our molecular diagnostic products stem from expert and innovative investigation into the biological underpinnings of serious human disease.

Our products stem from expert and innovative investigation into the biological underpinnings of serious human disease.

We plan to continue to use our proprietary DNA sequencing and RNA expression technologies, including our supporting bioinformatics and robotic technologies, in an effort to efficiently discover and validate important biomarkers.

We embed these biomarkers along with relevant clinical information in complex, proprietary tests that are highly accurate and informative, and intended to help physicians better manage their patients’ health care.

We believe that our technologies provide us with a significant competitive advantage and the potential for numerous product opportunities.

For the year ended December 31, 2021, the transition period ended December 31, 2020, and the years ended June 30, 2020 and 2019, we incurred research and development expense of $81.9 million, $35.8 million, $77.2 million and $85.9 million, respectively.

We believe that our technologies provide us with a significant competitive advantage and the potential for the continued development of numerous product opportunities.

For the year ended December 31, 2022, the year ended December 31, 2021, the six-month transition period ended December 31, 2020, and the fiscal year ended June 30, 2020, we incurred research and development expense of $85.4 million, $81.9 million, $35.8 million and $77.2 million, respectively.

Industry and Competition

Patients, healthcare providers, payors and health systems are looking to apply the power of genetic insights, molecular diagnostics and precision medicine to achieve improved clinical outcomes and lower cost.

Key industry trends include:

Healthcare is evolving to be more patient-centered and value-based.

Patients, healthcare providers, payors and health systems are looking to apply the power of genetic insights, molecular diagnostics, and precision medicine to advance care, improve access, and lower cost.

We believe key industry trends include:

• accelerating shifts in consumer engagement, early detection, home-based care models, the rise of low-cost sequencing, telemedicine, and virtual care;

• disruption in the way outpatient care is delivered in the midst of the COVID-19 pandemic, coupled with broadened awareness of the vital role of diagnostic testing;

• disruption in the way outpatient care is delivered as a result of the COVID-19 pandemic, coupled with broadened awareness of the vital role of diagnostic testing;

• expanding access to genetic insights, particularly among underserved populations with increased focus on health equity, reducing disparities in health care outcomes, and ensuring increased access for challenged communities;

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• growth in personalized medicine and the interest in new partnership models to advance companion diagnostics and serve patients with specific treatments based on their own genetic makeup and biology.

These market trends create new opportunities to position Myriad for growth and commercial success through enhanced customer service levels and a stronger alignment of our value proposition with physicians and payors.

Our focus is on innovative science that improves health outcomes, access for all, and ease of experience in the genetic testing process.

We expect to use our ability to innovate not only in research, development and technology, but also in go-to-market approaches, commercial capabilities, and tech-enabled applications so that we can adapt quickly to customer preferences and market dynamics.

In oncology, we offer genetic testing for patients who have cancer and companion diagnostic tests that work with corresponding drugs and treatments.

We believe these market trends create new opportunities to position us for organic growth and commercial success through the launch of new products and the enhancement of existing products.

Our focus is on articulating the clinical differentiation of our products and our commitment to being a reliable testing partner to patients and providers and innovative science that improves health outcomes, access for all, and ease of experience in the testing process.

We expect to use our ability to innovate not only in research, development, and technology, but also in go-to-market approaches, commercial capabilities, and tech-enabled applications to adapt quickly to customer preferences and market dynamics.

In oncology, we offer testing for patients who have cancer and companion diagnostic tests that work with corresponding drugs and treatments.

Our competitors in the oncology market include Invitae Corporation, Ambry Genetics Corporation, Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, Exact Sciences Corporation, Foundation Medicine, Inc.

and other commercial and academic laboratories.

We believe that the key opportunities to grow our business are our expansion of companion diagnostics, market expansion through new clinical guidelines, and providing new offerings.

In the first quarter of 2022, we plan to launch Precise Tumor, part of a differentiated, comprehensive solution for advanced precision oncology, in partnership with Intermountain Precision Genomics and Illumina.

In mid-2021, we launched our MyRisk Hereditary Cancer Test enhanced with RiskScore for all ancestries, creating the first and only hereditary cancer test that incorporates genetic markers for patients without a high-risk gene mutation.

In early 2021, we partnered with Illumina to offer a MyChoice CDx kit as part of their Trusight oncology offering.

This kit will be marketed to international markets and we expect it will increase global access to our MyChoice CDx solution.

This partnership combines Illumina's expertise in next-generation sequencing with Myriad's proprietary MyChoice CDx assay technology to advance comprehensive genetic profiling of tumor samples and drive improved outcomes in oncology.

These collaborations reflect our focus on partnering with high-caliber health care leaders to bring innovative solutions to the oncology market.

As a leader in genetic testing and precision medicine, we provide insights that help people take control of their health, and enable healthcare providers to better detect, treat, and prevent disease.

We believe that the key opportunities to grow our Oncology business are our expansion of companion diagnostics, market expansion through new clinical guidelines, and providing new offerings.

For example, in the first quarter of 2022, we launched the Precise Tumor Molecular Profile Test in partnership with Intermountain Precision Genomics and Illumina and as part of Precise Oncology Solutions, a differentiated, comprehensive solution for advanced precision oncology.

In March 2022, we received FDA approval for the BRACAnalysis CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza (olaparib).

We currently offer our FDA-approved BRACAnalysis CDx test as a companion diagnostic for the prediction of response to PARP inhibitors.

Currently, we are the only laboratory with an FDA-approved germline test for this indication and have received approvals from the FDA in ovarian cancer, metastatic breast cancer, pancreatic cancer, and advanced prostate cancer.

In May 2020, we received FDA approval for the MyChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency status, who are eligible or may become eligible, for treatment with Lynparza (olaparib) in combination with bevacizumab.

We recently received additional approvals from U.S., European, and Japanese regulatory agencies for the use of MyChoice CDx® in predicting response to PARP-inhibitors in ovarian cancer.

In addition, we plan to further expand MyChoice CDx® for use as a companion diagnostic indicator for additional cancer types, including pancreatic, prostate, and breast cancer.

In August 2022, we received approval from the Japanese regulatory agencies for the use of BRACAnalysis Diagnostic System as a companion diagnostic to identify patients with germline BRCA-mutated (gBRCAm) and HER2-negative high-risk recurrent breast cancer who may benefit from Lynparza (olaparib).

In late 2023, we also plan to add, also in partnership with Intermountain Precision Genomics, a new liquid biopsy therapy selection test called Precise Liquid to the comprehensive Precise Oncology Solutions offering.

We are also developing Precise MRD, a monitoring test based on whole genome sequencing to deeply interrogate tumors, detect cancer recurrence earlier, and help guide treatment decisions.

Women’s Health

In the women’s health market, we serve women assessing their genetic predisposition to cancer, offer prenatal tests for the assessment of fetal chromosomal disorders, and screen prospective parents for recessive genetic conditions that can be passed on to their offspring.

We compete with multiple companies including large national reference laboratories, specialty laboratories, academic/university laboratories, and kit-based products with our MyRisk, RiskScore, Foresight, and Prequel tests.

Our competitors include Invitae Corporation, Natera, Inc., Ambry Genetics Corporation, Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, and Sema4 Holdings Corp.

We compete mainly based on our test breadth and accuracy, commercial scale in the prenatal market, and the quality of our customer service and informatics tools.

We also offer the SneakPeek Early Gender DNA Test which can reveal a baby's gender as early as six weeks into pregnancy.

We compete with multiple companies, including large national reference laboratories, specialty laboratories, academic/university laboratories, and kit-based products with our MyRisk, Foresight, Prequel and SneakPeek tests.

Our competitors include Invitae Corporation, Natera, Inc., Ambry Genetics Corporation, a subsidiary of Konica Minolta Inc., Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, and Peekaboo Early Detection Gender DNA Test.

We compete mainly based on our test breadth and accuracy, equity in care capability, and our commercial scale.

We see opportunities to improve both our economics and the customer experience on these products.

We remain focused on the reimbursement for carrier screening and finding streamlined patient payment models.

As mentioned above, we recently launched our MyRisk Hereditary Cancer Test enhanced with RiskScore for all ancestries.

This test provides a genetically informed breast cancer risk assessment as part of a comprehensive panel, with equity in care for all patients and expanded access to genetic insights for more ethnic groups.

We are expanding new channels to interact with patients and for customers to have greater access to our products.

We also plan to improve customer experience with a new online MyRisk portal to engage with patients and physicians, patient cost estimators across our product lines, and AI-based tools for interacting with patients.

The launch of our AMPLIFY™ technology in 2020 further increased the accuracy of the Prequel test, enabling more women to receive highly accurate test results regardless of BMI, race, or ethnicity, permitting them to make more informed choices about whether to pursue diagnostic testing.

Moving forward we expect to further simplify and advance prenatal care with the launch of FirstGene ™ for comprehensive prenatal screening.

FirstGene combines the power of our Prequel NIPS with our Foresight Carrier Screen and provides insight into fetal recessive status.

This new test, which is expected to launch in 2023, is designed to streamline the testing process and simplify workflow with a single maternal blood draw while providing early insight on the fetus with improved sensitivity for all pregnancies, helping to reduce unnecessary amniocentesis.

We are expanding new sales and marketing channels to interact with patients and allow customers greater access to our products.

For example, with our recent acquisition of Gateway and its home-based SneakPeek Early Gender DNA Test, we have greater access to consumers who are pregnant and opportunities to convert these customers into prenatal testing patients as well as cancer screening patients.

We also plan to improve customer experience with our new online unified ordering portal to engage with patients and physicians, our cost estimators across our product lines, our remote in-market customer service teams, and artificial intelligence-based tools for interacting with patients.

We expect to further simplify and advance prenatal care with the launch of FirstGene ™, a comprehensive prenatal screening test.

FirstGene combines the power of our Prequel NIPS with AMPLIFY technology with our Foresight Carrier Screen into a new 4-in-1 prenatal offering for NIPS, carrier screen, fetal recessive status, and feto-maternal blood compatibility.

This new test, which is expected to launch in the third quarter of 2023, is designed to streamline the testing process and simplify workflow with a single maternal blood draw while providing early insight on the fetus with improved sensitivity for all pregnancies, helping to reduce unnecessary amniocentesis.

We recently announced our support for the recent guideline update by the American College of Medical Genetics and Genomics (ACMG), which reaffirmed the clinical value of NIPS to screen for a range of chromosomal abnormalities.

ACMG continues to recommend offering screening for common trisomies (on chromosomes 13, 18, and 21) in all pregnancies, and recently updated guidance that provides a strong recommendation for offering screening for sex-chromosome aneuploidies (SCAs) and conditional support for offering screening for 22q microdeletion syndrome.

As part of the NIPS within FirstGene, both SCAs and 22q are expected to be available as additional opt-in screening.

Mental Health

In mental health, we help physicians understand how genetic alterations impact patient response to antidepressants and other drugs.

Our GeneSight Mental Health Medication Test meets a significant unmet clinical need and is a leading product to help physicians anticipate patient response to psychotropic drugs, the selection of which has historically been done through trial and error based approaches.

The test is clinically proven to improve response rates in patients.

Our competitors in this market include Genomind, AltheaDx, Inc., and numerous other commercial and academic laboratories.

Key opportunities to grow our business in this market include primary care expansion, commercial payor reimbursement, and telehealth partnerships.

We are broadening access to GeneSight among front-line providers of mental health treatment, including primary care physicians and nurse practitioners who treat the majority of depression and anxiety patients, and through the expansion of sales and digital marketing capabilities.

Moving forward we are exploring the extension of GeneSight in other potential areas including postpartum depression through our Women's Health channel.

Separately, based on the market need, we are exploring new partnerships to develop tests for early detection and treatment of degenerative neurological conditions such as Alzheimer's disease and dementia.

Across the core specialties of our business – Women’s Health, Oncology, and Mental Health – we have numerous opportunities to elevate our products.

We have a respected portfolio and internationally recognized scientific know-how.

In mental health, we help physicians understand how genetic alterations may impact patient response to antidepressants and other drugs.

We believe our GeneSight Psychotropic Mental Health Medication Test meets a significant unmet clinical need and is a leading product to help physicians anticipate patient response to psychotropic drugs, the selection of which has historically been done through trial and error based approaches.

The test is clinically proven to improve response rates in patients compared to standard of care.

Our competitors in this market include Genomind, Quest Diagnostics Incorporated, and Laboratory Corporation of America Holdings.

Key opportunities to grow our business in this market include growing awareness of pharmacogenomic opportunities for mental health treatment and driving physician adoption and utilization of our product to help guide treatment options.

We are broadening access to GeneSight among front-line providers of mental health treatment, including primary care physicians and nurse practitioners who treat the majority of patients suffering from depression and anxiety, and through the expansion of sales and digital marketing capabilities.

Moving forward, we are exploring the extension of GeneSight in other indications as well as other areas such as postpartum depression through our Women's Health business.

We have historically experienced seasonality in our testing business.

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Additionally, the volume of testing is negatively impacted by the summer season, which is generally reflected in the quarter ended September 30th.

These seasonality patterns have generally continued during the COVID-19 pandemic, but due to the continued uncertainty surrounding the COVID-19 pandemic, we cannot predict if seasonality will follow the same pattern as in prior years.

Human Capital Management

Myriad's mission is to advance health and well-being for all, empower individuals with vital genetic insights and enable healthcare providers to better detect, treat and prevent disease.

Our mission is to advance health and well-being for all by empowering individuals with vital insights to help them take control of their health and enabling healthcare providers to better detect, treat and prevent disease.

We believe the success of our mission depends, in part, on our ability to attract and retain qualified personnel.

Our key human capital management objectives are to recruit, retain and motivate the exceptional people needed to carry out our mission.

To support these objectives and help our employees balance their work and personal lives, we maintain a flexible work environment, competitive compensation and benefits programs.

To support these objectives and help our employees balance their work and personal lives, we maintain a flexible work environment and competitive compensation and benefits programs.

As of December 31, 2022, we have approximately 2,600 full-time equivalent employees.

Most of our employees are engaged directly in customer experience, research, technology, development, production, sales and marketing activities.

Most of our employees are engaged directly in customer experience, research, technology, development, production, and sales and marketing.

Our employees are not covered by a collective bargaining agreement, and we consider our relations with our employees to be good.

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Our DE&I objective is to make Myriad a place where all employees have a sense of belonging.

To achieve this objective, we have adopted diversity, equity and inclusion goals into our human capital management strategy.

Myriad has three employee-led resource groups (ERGs) that represent and support three diverse communities in our workforce:

Myriad supports a culture of diversity, equity, and inclusion aligned with our company mission, vision, and values to drive company performance by creating opportunities and experiences for learning, development, and a sense of belonging for all employees.

Our DE&I plan is focused on our people, mission, and community.

We have three employee-led resource groups (ERGs) that represent and support three diverse communities in our workforce:

the Pride Alliance Group, the Black Employees at Myriad Group and the Women's Leadership Group.

We plan to add more ERGs that serve other interest and cultural groups.

These ERGs mentor, foster, encourage, and inspire employees in all stages of their careers by providing access to senior leadership, peer groups, mentoring, and other valuable resources to help them pursue their career ambitions.

As of December 31, 2021, 61% of our employees are women and women hold 42% of leadership roles (vice president and above).

One third of the members of our Board of Directors are women, including the chairperson.

As of December 31, 2022, 62% of our employees are women and women hold 46% of Myriad leadership roles (vice president and above).

One third of the members of our Board of Directors are women, including the chairperson, and 44% of our Board members come from diverse gender, ethnic, and cultural backgrounds.

Compensation, Health, Wellness, Family Resources, and Other Benefits :

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We provide competitive salaries, stock ownership opportunities, and enhanced incentive and bonus programs.

We also provide an expansive benefit offering including medical, dental and vision health care coverage, insurance and disability coverage, 401(k) investment plans with Company matching, tax advantaged savings accounts, paid time off and leaves of absence, employee assistance programs, community outreach programs, training and development opportunities and wellness programs.

We also provide an expansive benefit offering including medical, dental and vision health care coverage, insurance and disability coverage, 401(k) investment plans with Company matching, tax advantaged savings accounts, paid time off and leaves of absence, parental leave, family formation benefits, employee assistance programs, community outreach programs, training and development opportunities, and wellness programs.

We provide added work life balance to our employees through hybrid work arrangements.

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Oversight and Management :

We regularly conduct surveys to seek feedback from our employees on a variety of topics, including but not limited to, employee engagement, Company strengths and focus areas, and culture drivers.

The results are reviewed by the Board of Directors, the Compensation and Human Capital Committee and senior leadership, who analyze areas of progress or deterioration and prioritize actions and activities in response to this feedback to drive meaningful improvements in employee engagement.

We regularly conduct surveys to seek feedback from our employees on a variety of topics, including employee engagement, Company strengths and focus areas, and culture drivers.

The results are reviewed by our Board of Directors, the Compensation and Human Capital Committee and senior leadership, who analyze areas of progress or deterioration and prioritize actions and activities in response to this feedback to drive meaningful improvements in employee engagement.

Social Responsibility and Community :

At Myriad, corporate responsibility plays an important role in our approach to discovering and delivering valuable and transformative diagnostic tests across major diseases to improve patients' lives.

At Myriad, corporate responsibility plays an important role in our approach to developing valuable and transformative diagnostic tests across major diseases to improve patients' lives.

We believe that our corporate social responsibility programs build greater value for our patients, healthcare professionals and stockholders, support and improve the communities where we live and work, and empower our employees to become more engaged in the well-being of their own communities.

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• Philanthropy :

Myriad provides financial support to nonprofit organizations and shares the expertise of Myriad employees in the communities where we operate.

Myriad collaborates with and supports key patient advocacy and support organizations where we can make a positive difference in addressing complex health challenges, providing and improving the quality of life for patients.

We provide financial support to nonprofit organizations and share the expertise of our employees in the communities where we operate.

We collaborate with and support key patient advocacy and support organizations where we can make a positive difference in addressing complex health challenges, providing and improving the quality of life for patients.

• Scholarship :

Myriad provides financial support for academic scholarship and education at both the undergraduate and post-graduate levels and contributes to advancing education and training for women and minorities in medicine and science.

We provide financial support for academic scholarship and education at both the undergraduate and post-graduate levels and contribute to advancing education and training for women and minorities in medicine and science.

• Patient Assistance :

Myriad is working to improve overall health care quality and increase access to diagnostic testing for uninsured and underinsured populations by offering robust financial assistance and free testing to those in need.

We are working to improve overall health care quality and increase access to diagnostic testing for uninsured and underinsured populations by offering robust financial assistance and free testing to those in need.

• Environmental :

As described further below, Myriad has created a Green Team to foster environmental and sustainability stewardship.

As described further below, we have created a Green Team to foster environmental and sustainability stewardship.

Environmental and Sustainability

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The Nominating, Environmental, Social and Governance Committee of our Board of Directors is responsible for reviewing and evaluating our environmental, climate, safety, social and other corporate responsibility strategies, practices, and initiatives.

We have also formed an internal Environmental, Social, and Governance (ESG) Committee, led by our President and Chief Executive Officer, and created a Green Team in an effort to reduce material waste, optimize energy and emissions usage, reduce water use, air pollution, and hazardous material use, perform community outreach, promote employee health and safety and manage other environmental projects.

We are committed to the health and safety of our employees and have formed a health and safety committee.

During the COVID-19 pandemic, we have aligned with CDC guidelines to help protect our employees.

In addition to requiring all employees to wear masks and adhere to social distancing guidelines, we have also made an effort to track and mitigate internal exposure to COVID-19 when we learn of employee exposure or infection.

Additionally, we offer COVID-19 test kits to employees who may have come in contact with someone exposed to COVID-19 as an additional benefit to our employees and to limit disruption to our business operations.

We have also postponed all non-essential and international business travel and encouraged all employees to get vaccinated against COVID-19, maintaining a voluntary count of employees that have been vaccinated.

We have also formed an internal Environmental, Social, and Governance (ESG) Committee, led by our President and Chief Executive Officer, and created a Green Team in an effort to develop and maintain sustainable business practices.

For more information on our approach to sustainability, please refer to our 2021 Environmental, Social and Governance Report, which is available on our website.

Our 2022 Environmental, Social and Governance Report is expected to be released later this year.

Patents and Proprietary Rights

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For some of the patent assets, we hold rights through exclusive or non-exclusive license agreements.

Material patent assets relating to our tests that generate material revenue are described in the table below.

Material issued patent assets relating to our tests that generate material revenue are described in the table below, along with any related pending applications.

These issued patents are expected to begin expiring on the respective dates noted below and any related applications, if issued as patents and depending on term adjustments or terminal disclaimers, if applicable, are expected to have similar expiration timeframes.

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Claims relating to biomarkers, kits, systems and methods for detecting homologous recombination deficiency and selecting therapy based on such detection.

GeneSight Mental Health Medication Test We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S.

GeneSight Psychotropic Mental Health Medication Test We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S.

and other jurisdictions relating to GeneSight ® testing.

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Any patent applications which we have filed, or will file, or to which we have licensed or will license rights may not issue, and patents that do issue may not contain commercially valuable claims.

In addition, others may obtain patents having claims which cover aspects of our tests or processes which are necessary for or useful to the development, use or performance of our diagnostic products.

Should any other group obtain patent protection with respect to our discoveries, our commercialization of our molecular diagnostic tests could be limited or prohibited.

Others may offer clinical diagnostic genomic laboratory testing services which may infringe patents we control.

In addition, others may obtain patents having claims which cover aspects of our tests or processes which are necessary for or useful to the development, use or performance of our products.

Should any other group obtain patent protection with respect to our discoveries, our commercialization of our tests could be limited or prohibited.

Others may offer genomic laboratory testing services which may infringe patents we control.

We may seek to negotiate a license to use our patent rights or decide to seek enforcement of our patent rights through litigation.

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We also rely upon unpatented proprietary technology, and in the future may determine in some cases that our interests would be better served by protecting certain technologies as trade secrets or through confidentiality agreements rather than patents or licenses.

These include some of our genomic, proteomic, RNA expression, mutation analysis, robotic and bioinformatic technologies which may be used in discovering and characterizing new biomarkers and ultimately used in the development or analysis of molecular diagnostic tests.

We also maintain a database of gene mutations and their status as either harmful or benign for some of our tests.

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License Agreements

We are a party to license agreements which give us the rights to use certain technologies in the research, development, testing processes, and commercialization of our molecular diagnostic tests.

We are a party to license agreements which give us the rights to use certain technologies in the research, development, testing processes, and commercialization of our tests.

These licenses generally end on the expiration of the last to expire patent rights covered by the applicable license agreement.

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Our failure to maintain rights to this technology could have a material adverse effect on our business.

We have licenses with the following entities:

The table below lists important licenses to technology that is incorporated into tests that generate material revenue:

Entity Subject Royalties Expiration

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Anderson Cancer Center (UTMDACC) Exclusive world-wide right to certain rights of UTMDACC in intellectual property relating to our MyChoice ® HRD testing.

We will pay UTMDACC a royalty based on net sales of our MyChoice® HRD test.

We pay UTMDACC a royalty based on net sales of our MyChoice ® HRD test.

We do not anticipate that this license will expire until 2032.

Children’s Medical Center in Boston (CMCC) Exclusive world-wide right to certain rights of CMCC in intellectual property relating to our MyChoice ® HRD testing.

We expect to pay CMCC a royalty based on net sales of our MyChoice® HRD test.

We pay CMCC a royalty based on net sales of our MyChoice ® HRD test.

We do not anticipate that this license will expire until 2032.

Institut Curie and INSERM (INSERM) Exclusive world-wide right to certain rights of INSERM in intellectual property relating to our MyChoice ® HRD testing.

We expect to pay INSERM a royalty based on net sales of our MyChoice® HRD test.

We pay INSERM a royalty based on net sales of our MyChoice ® HRD test.

We do not anticipate that this license will expire until 2032.

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Our laboratories in Salt Lake City, Utah, Mason, Ohio, and South San Francisco, California are CLIA certified to perform high complexity tests.

In addition, CLIA requires each of our certified laboratories to enroll in an approved proficiency testing program if performing testing in any category for which proficiency testing is required.

CLIA requires each of our certified laboratories to enroll in an approved proficiency testing program if performing testing in any category for which proficiency testing is required.

Each of our laboratories periodically tests specimens received from an outside proficiency testing organization and then submits the results back to that organization for evaluation.

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The biennial survey is conducted by the Centers for Medicare & Medicaid Services (CMS), a CMS agent (typically a state agency), or a CMS-approved accreditation organization.

Because our laboratories are accredited by the College of American Pathologists (“CAP”), which is a CMS-approved accreditation organization, they are typically subject to CAP inspections.

Because our laboratories are accredited by the College of American Pathologists (CAP), which is a CMS-approved accreditation organization, they are typically subject to CAP rather than CMS inspections.

Our laboratories are licensed by the appropriate state agencies in the states in which they operate, if such licensure is required.

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Congress has also signaled interest in clarifying the regulatory landscape for LDTs.

In 2020, the Verifying Accurate, Leading-edge IVCT Development (“VALID”) Act was introduced in both chambers of Congress, and it was reintroduced in revised form for the 117th Congress in July 2021.

Most recently, reform entitled the Verifying Accurate, Leading-edge IVCT Development (VALID) Act has received bipartisan congressional support as revisions continue to be made to the bill.

If enacted, clinical laboratories that develop and offer LDTs and traditional IVD medical device manufacturers would be subjected to the same regulatory oversight.

The VALID Act defines both LDTs and IVDs as in vitro clinical tests (IVCT) and would establish a new regulatory framework separate and apart from the medical device framework under the Food, Drug and Cosmetic Act (FDCA) for the review and oversight of IVCTs.

The proposed regulatory framework adopts various concepts from the FDCA, utilizing a risk-based approach that aims to ensure that all marketed IVCTs have a reasonable assurance of both analytical and clinical validity.

The VALID Act would also create a new system for clinical laboratories and hospitals to submit their clinical tests electronically to the FDA for approval.

The VALID Act would also create a new system for clinical laboratories and hospitals to submit their clinical tests electronically to the FDA for approval, among other potentially significant changes to current regulatory requirements applicable to the lab industry as a whole.

This system is aimed at reducing the amount of time that it takes for the agency to approve such tests, and it establishes a new program to expedite the development of diagnostic tests that can be used to address a current unmet need for patients.

It is unclear whether the VALID Act would be passed by Congress in its current form or signed into law by the President.

In Vitro Diagnostics

It is unclear whether the VALID Act will be passed by Congress in its current form or signed into law by the President;

if enacted, however, it is expected to require clinical laboratories to spend significant time, resources, and money towards ensuring compliance.

In Vitro Diagnostics as Medical Devices

The information that must be submitted to the FDA in order to obtain clearance or approval to market a new IVD varies depending on how the device is classified by the FDA.

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510(k) Premarket Notification and De Novo Classification

A 510(k) notification requires the sponsor to demonstrate that an IVD is substantially equivalent to another marketed device, termed a “predicate device,” that is legally marketed in the United States and for which a premarket approval application (“PMA”) was not required.

A device is substantially equivalent to a predicate device if it has the same intended use and technological characteristics as the predicate;

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Requests for additional data, including clinical data, will increase the time necessary to review the notice.

If the FDA believes that the IVD is not substantially equivalent to a predicate device, it will issue a “Not Substantially Equivalent” letter, stating that the new device may not be commercially distributed and designating the device as a Class III device, which will require the submission and approval of a PMA before the new device may be marketed.

Alternatively, the applicant may be able to submit a De Novo classification request to have it regulated as a Class I or Class II device.

In October 2021, the FDA issued a final rule to formally codify requirements for the procedures and criteria for product developers to follow when preparing a De Novo classification request;

The FDA recently issued a final rule to formally codify requirements for the procedures and criteria for product developers to follow when preparing a De Novo classification request.

The new Do Novo regulations became effective on January 3, 2022.

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As an alternative to the De Novo classification process, the manufacturer could also file a reclassification petition seeking to change the automatic Class III designation of a novel post-amendment device under Section 513(f)(3) of the FDCA.

The FDA can also initiate reclassification of an existing device type on its own initiative.

The FDA issued a final rule in December 2018 to clarify the administrative process through which the agency reclassifies a medical device.

After a new medical device receives 510(k) clearance from the FDA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could require the submission of a PMA.

The FDA can also initiate reclassification of an existing device type on its own initiative, and it recently issued a final rule to clarify the administrative process through which the agency reclassifies a medical device.

The FDA continues to reevaluate the 510(k) pathway and other medical device programs and has taken what it describes as a risk-based approach to develop innovative regulatory policy to propose a more “contemporary” approach to the life cycle oversight of medical devices and IVDs.

We cannot predict what if any additional changes will occur or how they will affect our current or future products.

We cannot predict what if any additional regulatory changes will occur or how they will affect our current or future products.

Premarket Approval

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If the device is determined to present a “significant risk,” the sponsor may not begin a clinical trial until it submits an investigational device exemption (IDE) to the FDA and obtains approval to begin the trial.

After the PMA is submitted, the FDA has 45 days to make a threshold determination that the PMA is sufficiently complete to permit a substantive review.

If the PMA is complete, the FDA will file the PMA.

The FDA is subject to a performance goal review time for a PMA that is 180 days from the date of filing, although in practice this review time is longer.

After the PMA application is submitted, the FDA has 45 days to make a threshold determination that the PMA application is sufficiently complete to permit a substantive review.

If the PMA application is complete, the FDA will file the PMA.

The FDA is subject to a performance goal review time for a PMA application that is 180 days from the date of filing, although in practice this review time is longer.

Questions from the FDA, requests for additional data including additional clinical data and referrals to advisory committees may delay the process considerably.

The total process may take several years and there is no guarantee that the PMA will ever be approved.

The total process may take several years and there is no guarantee that the PMA application will ever be approved.

Even if approved, the FDA may limit the indications for which the device may be marketed.

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If a sponsor or the FDA believes that a diagnostic test is essential for the safe and effective use of a corresponding therapeutic product, the sponsor of the therapeutic product will typically work with a collaborator to develop an IVD companion diagnostic device.

The FDA issued a final guidance document in 2014 entitled “ In Vitro Companion Diagnostic Devices” that is intended to assist companies developing in vitro companion diagnostic devices and companies developing therapeutic products that depend on the use of a specific in vitro companion diagnostic for the safe and effective use of the product.

The FDA has issued a final guidance document entitled “ In Vitro Companion Diagnostic Devices” that is intended to assist companies developing in vitro companion diagnostic devices and companies developing therapeutic products that depend on the use of a specific in vitro companion diagnostic for the safe and effective use of the product.

In the guidance, the FDA defined an IVD companion diagnostic device as a device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.

The FDA also noted that in some cases, if evidence is sufficient to conclude that the IVD companion diagnostic device is appropriate for use with a class of therapeutic products, the intended use/indications for use should name the therapeutic class, rather than each specific product within the class.

In April 2020, FDA published a final guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” that expands on the idea of a class of therapeutic products introduced in the 2014 guidance.

In April 2020, FDA published another final guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” that expands on the idea of a class of therapeutic products.

The more recent guidance describes considerations for the development and labeling of in vitro companion diagnostic devices to support the indicated uses of multiple drug or biological oncology products, when appropriate.

The FDA expects that the therapeutic sponsor will address the need for an approved or cleared IVD companion diagnostic device in its therapeutic product development plan and that, in most cases, the therapeutic product and its corresponding IVD companion diagnostic will be developed contemporaneously.

To that end, the FDA issued draft guidance in July 2016 entitled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product” to serve as a practical guide to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic.

To that end, the FDA has also issued draft guidance entitled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product” to serve as a practical guide to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic, as well as draft guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” to facilitate class labeling on diagnostic tests for oncology therapeutic products.

The FDA has indicated that it will apply a risk-based approach to determine the regulatory pathway for IVD companion diagnostic devices, as it does with all medical devices.

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If the diagnostic test and the therapeutic drug are studied together to support their respective approvals, the clinical trial must meet both the IDE and investigational new drug application (IND) requirements.

We expect that any IVD companion diagnostic device developed for use with drug products will utilize the PMA pathway and that a clinical trial performed under an IDE will have to be completed before the PMA may be submitted.

We are developing companion diagnostic tests for use with drug products in development by pharmaceutical companies, such as our collaborations with pharmaceutical companies on PARP inhibitors for the treatment of ovarian, breast and other cancers.

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A complementary test can help guide treatment strategy and identify which patients are likely to derive the greatest benefit from therapy, and if approved by the FDA, information regarding the IVD will be included in the therapeutic product labeling.

Although the FDA has not yet issued any written guidance regarding complementary diagnostics, it has already approved some complementary diagnostics, including a supplementary premarket approval for BRACAnalysis CDx and MyChoice CDx as complementary diagnostic tests in ovarian cancer patients associated with enhanced progression-free survival (PFS) when used with the PARP inhibitor Zejula™ (niraparib).

In December 2014, we first obtained premarket approval for BRAC Analysis CDx, which is used as a companion diagnostic test to identify ovarian cancer patients who may benefit from AstraZeneca’s PARP inhibitor Lynparza™ (olaparib).

Since then, other indications for BRAC Analysis CDx in ovarian, breast, prostate and pancreatic cancer have received supplemental PMA approval as a companion diagnostic for Lynparza.

Although the FDA has not yet issued any written guidance regarding complementary diagnostics, it has approved some complementary diagnostics, including a supplementary premarket approval for BRACAnalysis CDx and MyChoice CDx as complementary diagnostic tests in ovarian cancer patients associated with enhanced progression-free survival (PFS) when used with the PARP inhibitor Zejula™ (niraparib).

In December 2014, we first obtained premarket approval for BRACAnalysis CDx, which is used as a companion diagnostic test to identify ovarian cancer patients who may benefit from AstraZeneca’s PARP inhibitor Lynparza™ (olaparib).

Since then, other indications for BRACAnalysis CDx in ovarian, breast, prostate and pancreatic cancer have received supplemental PMA approval as a companion diagnostic for Lynparza.

The MyChoice CDx test has also received approvals as a companion diagnostic test.

The premarket approval process is a complex, costly and time consuming procedure.

Approvals must be supported by valid scientific evidence, submitted as part of a PMA, which typically requires extensive data, including quality technical, preclinical, clinical and manufacturing data to demonstrate to the FDA’s satisfaction the safety and effectiveness of the companion diagnostic.

The premarket approval process for companion or complementary diagnostics is a complex, costly and time-consuming procedure.

Approvals must be supported by valid scientific evidence, submitted as part of a PMA application, which typically requires extensive data, including quality technical, preclinical, clinical and manufacturing data to demonstrate to the FDA’s satisfaction the safety and effectiveness of the companion diagnostic.

We are currently collaborating with several bio-pharmaceutical companies for additional indications and geographical commercialization opportunities for BRACAnalysis CDx and MyChoice CDx as companion diagnostics with other drugs.

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• compliance with the FDA’s Quality System Regulation (QSR), which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;

• labeling and advertising regulations, which prohibit the promotion of products for uncleared, or unapproved uses, or “off-label” uses, and impose other restrictions on labeling;

• labeling and advertising regulations, which prohibit the promotion of FDA-regulated medical products for uncleared, or unapproved uses, or “off-label” uses, and impose other restrictions on labeling;

• medical device reporting obligations, which require that manufacturers investigate and report to the FDA adverse events, including deaths, or serious injuries that may have been or were caused by a medical device and malfunctions in the device that would likely cause or contribute to a death or serious injury if it were to recur.

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and civil or criminal prosecution.

Rest of World Regulation of In Vitro Diagnostics and Companion Diagnostic Devices

Products intended for use in in vitro diagnostic applications require regulatory approvals in many other countries and geographic areas, some of which also provide for approval of companion diagnostics.

Regulation of In Vitro Diagnostics and Companion Diagnostic Devices Outside the United States

Products intended for use in IVD applications require regulatory approvals in many other countries and geographic areas, some of which also provide for approval of companion diagnostics.

European Union

In the European Union (“EU”), in vitro diagnostic medical devices have been regulated under the European Union Directive 98/79/EC (the “Directive”), since 2003, and all products and kits used for in vitro diagnostic applications must be compliant with the Directive.

IVDs have not been subject to pre-market authorization under the Directive, but instead they had to comply with essential requirements based on conformity with harmonized standards.

The majority of IVDs have been self-certified by manufacturers which can place a CE mark on most products to show that they meet the conformity assessment.

EU Member States must ensure that IVDs are only placed on the market if they conform to the requirements, and must ensure the free movement of such devices in the internal market.

Member States will designate independent organizations, or Notified Bodies, that ensure that a conformity assessment is carried out for devices.

These Notified Bodies may carry out inspections of certain manufacturers, and manufacturers must report any incident causing death to, or damaging the health of, a patient to the competent authorities.

In May 2022, the Directive will be replaced by the In Vitro Diagnostic Device Regulation (IVDR) European Union (EU) 2017/746 that was published in May 2017, and given a 5-year transition period until its implementation on May 27, 2022.

Unlike the Directive that specifies certain results that must be achieved by each Member State and permits each Member State to decide how to transpose the Directive into national law, the IVDR has binding legal force throughout every Member State and it will become effective on a set date in all the Member States.

In the European Union (EU), IVD medical devices historically were regulated under the EU Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (the Directive).

IVDs were not subject to pre-market authorization by a National Competent Authority (NCA) under the Directive, but instead had to comply with essential requirements based on conformity with harmonized standards.

For certain IVDs, compliance with the essential requirements was subject to assessment by a Notified Body.

Notified bodies are entities designated by the relevant NCAs and are responsible for assessing the conformity of IVDs before they are placed on the EU market.

Under the Directive, the majority of IVDs could be placed on the market as a result of the manufacturer self-certifying the IVD as being in conformity with the essential requirements, without the involvement of a Notified Body.

The Directive was replaced by the Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) that entered into force in May 2017, and which initially included a 5-year transition period until its original effective date of May 26, 2022.

Unlike the Directive, which specifies certain requirements that must be achieved by each Member State and permits each Member State to decide how to transpose the Directive into national law to meet those requirements, the IVDR has direct binding legal force throughout every Member State without the need for national implementation.

The major goals of the IVDR are to standardize diagnostic procedures within the EU, increase reliability of diagnostic analysis and enhance patient safety.

Under the IVDR, as enacted by the European Commission (EC), in vitro diagnostics will be subject to additional legal regulatory requirements after it comes into full effect.

Among other things, the IVDR introduces a new risk classification system and requirements for conformity assessments.

Products already certified by a Notified Body may remain on the market until May 25, 2024 under some conditions including fulfillment of specific requirements in the IVDR, but ultimately most products will have to be approved.

Under the IVDR, IVDs are subject to additional legal regulatory requirements as compared to the Directive.

Among other things, the IVDR introduces a new risk-based classification for IVDs and specifies CDx and genetic tests as Class C products (second highest risk).

Under the IVDR, Class C IVDs require assessment by a Notified Body for certification and audit of the manufacturer's quality management system before they can be placed on the market.

The IVDR also obligates laboratories located outside the EU to comply with the IVDR if testing specimens from European citizens.

Compliance with the IVDR may be expensive and time-consuming.

Manufacturers will need to provide more data to demonstrate that a device performs safely and effectively.

As noted above, the vast majority of IVDs under the Directive are self-certified, so many device manufacturers have not previously been subject to the Notified Body audits that will occur under the IVDR and will have to revise their Quality Management System (QMS) and Technical Documentation which will be reviewed.

Manufacturers will need to provide significant evidence to demonstrate that a device performs safely and effectively.

Performance data may require the conduct of additional clinical investigations or performance studies, with additional and more strict requirements under the IVDR.

Companion diagnostic IVDs may also be reviewed by the competent medicinal product authorities, usually the European Medicines Agency, as part of a consultation process that will be part of the conformity assessment procedure.

There will also be a greater emphasis on post-market surveillance and submission of post-market performance follow-up reports.

Due to multiple challenges to the IVDR being ready for full application by the May 2022 implementation date, Regulation (EU) 2022/112 of the Parliament and of the Council was published on 25 January 2022 allowing for a delay to the application of the IVDR by amending the transition provision for certain in vitro diagnostic medical devices.

For products classified as Class C under the IVDR, the transition period allows for legacy devices with a valid declaration of conformity drawn up prior to May 26, 2022 to continue to be placed on the market until May 26, 2026.

However, certain IVDR requirements, including post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices remained effective on the May 26, 2022 implementation date.

United Kingdom

The withdrawal of the United Kingdom (“UK”) from the EU has had significant ramifications for IVD manufacturers.

Among other things, IVD manufacturers have to follow new procedures in the UK including appointment of UK Responsible Persons rather than relying on European Authorized Representatives to manage their compliance efforts in the UK.

The UK Medicine and Healthcare Products Regulatory Agency (“MHRA”) issued guidance on regulation of IVDs in the UK following January 1, 2021.

After a transition period, IVDs will require certification in Great Britain, which is defined as England, Scotland and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU IVD regulations.

As described in the guidance, MHRA will continue to recognize CE marks until June 30, 2023.

Companies wishing to place IVDs on the UK market have been required to register with MHRA since January 1, 2021, but will still be able to sell CE-IVD marked products until June 30, 2023.

Starting July 1, 2023, companies selling in the UK will have to obtain a new marking called a UK Conformity Assessed mark (“UKCA”) in order to place a diagnostic device into commerce in Great Britain.

This mark will not be automatically recognized in EU countries, meaning that companies that wish to sell in the UK and the EU will have to seek both a UKCA and CE-IVD mark in the future.

The withdrawal of the United Kingdom (UK) from the EU has had ramifications for IVD manufacturers.

Among other things, IVD manufacturers have to follow new procedures in the UK including appointment of a UK Responsible Person to manage their compliance efforts in the UK.

The UK Medicine and Healthcare products Regulatory Agency (MHRA) issued guidance on the regulation of IVDs in the UK following Brexit, and changed the applicable legislation in the UK to take account of the fact that the UK is not a free-standing regulatory regime.

As described in these provisions, MHRA will continue to recognize CE marks until July 2024.

Companies wishing to place IVDs on the UK market have been required to register with MHRA since January 1, 2021, but are still able to sell CE-IVD marked products in Great Britain, which is defined as England, Scotland and Wales, until July 2024.

From approximately July 2024, when new legislation is intended to come into force, companies selling in the UK will have to obtain a new marking called a UK Conformity Assessed mark (UKCA) in order to place a diagnostic device into commerce in Great Britain.

This mark, which can be obtained now, is not recognized in EU countries, meaning that companies that wish to sell in the UK and the EU will have to seek both a UKCA and CE-IVD mark in the future.

The EU legislative framework applies in Northern Ireland, meaning that companies can still, and will still be able to, sell tests in Northern Ireland under applicable EU IVD regulations including the current IVDR.

IVDs are regulated in Japan by the Pharmaceutical and Medical Devices Agency (PMDA) and are assigned to one of three classes depending on the perceived level of risk.

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Submissions may be made only by marketing authorization holders, which must satisfy specific requirements.

Significant revisions to Japanese regulations of medical devices, IVDs and other health care products are ongoing, with phased implementations of new and updated requirements planned through 2022.

Significant revisions to Japanese regulations of medical devices, IVDs and other health care products are ongoing.

The first round of changes to Japan’s Pharmaceuticals and Medical Devices Act took effect September 1, 2020 and August 2021, with additional revisions coming into force in December 2022.

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HIPAA's privacy rule also limits many disclosures of protected health information to the minimum amount necessary to accomplish an intended purpose.

The HIPAA security standards require the adoption of administrative, physical, and technical safeguards and the adoption of written security policies and procedures.

On February 17, 2009, Congress enacted the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which expanded and strengthened HIPAA, created new targets for enforcement, imposed new penalties for noncompliance and established new breach notification requirements for Covered Entities.

The HIPAA security standards require the adoption of administrative, physical, and technical safeguards for the protection of protected health information and the adoption of written security policies and procedures.

The Health Information Technology for Economic and Clinical Health Act (HITECH) expanded and strengthened HIPAA, created new targets for enforcement, imposed new penalties for noncompliance and established new breach notification requirements for Covered Entities.

Under HITECH’s breach notification requirements, Covered Entities must report breaches of protected health information that has not been encrypted or otherwise secured in accordance with guidance from the Secretary of the U.S.

Department of Health and Human Services (the “Secretary”).

Department of Health and Human Services.

Required breach notices must be made as soon as is reasonably practicable, but no later than 60 days following discovery of the breach.

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Breach reports can lead to investigation, enforcement, civil monetary penalties and civil litigation, including class action lawsuits and enforcement by state.

We are currently subject to the HIPAA regulations and maintain an active compliance program that is designed to meet requirements of the privacy and security rules and to identify security incidents and other issues in a timely fashion so that we may remediate, mitigate harm and report if required by law.

We are currently subject to the HIPAA regulations and maintain an active compliance program that is designed to meet requirements of the privacy and security rules and to identify privacy and security incidents and other issues in a timely fashion so that we may remediate, mitigate harm and report if required by law.

However, even if we take steps to comply with HIPAA, we may be subject to complaints and investigation at the federal and/or state level.

In the event of a breach, even if we mitigate harm and make required reports on a timely basis, we may still be subject to penalties for the underlying breach.

In addition to the federal privacy and security regulations, there are a number of state laws regarding the privacy and security of health information and personal data that are applicable to our clinical laboratories.

Many states have also implemented genetic testing and privacy laws imposing specific patient consent requirements and protecting test results by strictly limiting the disclosure of those results.

In addition to the federal privacy and security regulations, there are a number of state laws regarding the privacy and security of health information and personal data that can be applicable to our clinical laboratories, as further discussed in the "Risk Factor" section below.

Many states have also implemented genetic testing laws imposing specific patient consent requirements and protecting genetic information by limiting the disclosure of such information.

State requirements are particularly stringent regarding predictive genetic tests, due to the risk of genetic discrimination against healthy patients identified through testing as being at risk for disease.

We believe that we have taken the steps required of us to comply with health information privacy and security statutes and regulations, including genetic testing and genetic information privacy laws in all jurisdictions, both state and federal.

However, these laws often change, and we may not be able to maintain compliance in all jurisdictions where we do business.

Failure to maintain compliance with state or federal laws regarding privacy or security could result in civil and/or criminal penalties and significant reputational damage and could have a material adverse effect on our business.

The General Data Protection Regulation (“GDPR”), which imposes requirements regarding the handling of personal data about EU residents, also applies to some of our operations.

The GDPR is discussed in more detail under the heading “Risk Factors” contained in Item 1A of this report.

Compliance with health information privacy and security statutes and regulations, including genetic testing and genetic information privacy laws in all jurisdictions, both state and federal, can be challenging as these laws often change, and we may not be able to maintain compliance in all jurisdictions where we do business.

Transparency Laws and Regulations

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• disputes with payors as to the appropriate level of reimbursement.

Depending on the reimbursement arrangement and applicable law, the party that reimburses us for our services may be:

Depending on the reimbursement arrangement and applicable law, the party that reimburses us for our tests may be:

• a third party who provides coverage to the patient, such as an MCO;

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PAMA took effect on January 1, 2018 and requires applicable laboratories to report to CMS private insurer payment rates and volumes for their tests.

CMS uses the data reported and the HCPCS code associated with the test to calculate a weighted median payment rate for each test, which is used to establish revised Medicare CLFS reimbursement rates for tests that are considered to be clinical diagnostic laboratory tests (“CDLTs”), subject to certain phase-in limits.

CMS uses the data reported and the Healthcare Common Procedure Coding System code associated with the test to calculate a weighted median payment rate for each test, which is used to establish revised Medicare CLFS reimbursement rates for tests that are considered to be clinical diagnostic laboratory tests (CDLTs), subject to certain phase-in limits.

For tests furnished on or after January 1, 2019, Medicare payments for CDLTs are based on reported private payor rates.

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Then, on December 10, 2021, Congress passed the Protecting Medicare and American Farmers from Sequester Cuts Act, which included a provision that further delayed the next PAMA reporting period for CDLTs that are not ADLTs to January 1, 2023 through March 31, 2023.

The Consolidated Appropriations Act, 2023 enacted on December 29, 2022 again delayed the next PAMA reporting period to January 1, 2024 through March 31, 2024.

New CLFS rates for CDLTs will be established based on that data beginning in 2025, subject to phase-in limits.

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The CARES Act delayed for one year the 15% cut that was scheduled to take effect on January 1, 2021, and the Protecting Medicare and American Farmers from Sequester Cuts Act further delayed those cuts until 2023.

The Consolidated Appropriations Act, 2023, again delayed the cuts until 2024.

The subsequent data reporting period for CDLTs that are not ADLTs will occur in three-year cycles, with the next cycle beginning in 2027.

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In other words, balance billing generally is prohibited.

Because these billing requirements do not apply to patient specimens collected in a physician office, Myriad is impacted primarily when a patient’s specimen is collected at an in-network hospital, and Myriad is out-of-network with the patient’s insurance plan.

Because these billing requirements do not apply to patient specimens collected in a physician office, Myriad is impacted primarily when a patient’s specimen is collected at an in-network hospital, and Myriad is an out-of-network provider under the patient’s insurance plan.

Out-of-network rates for covered services are determined by a state All-Payer Model Agreement, a specified state law, an agreed-upon amount, or, if none apply, an amount determined by an independent dispute resolution entity.

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In addition, providers, including Myriad, must post consumer notices on their website about the applicability of the law.

Providers, including physician offices, must provide a good faith estimate of the service when requested by a patient who is uninsured or seeking to forgo insurance and pay cash instead.

Providers, including physician offices, must provide a good faith estimate of the cost of the service when requested by a patient who is uninsured or seeking to forgo insurance and pay cash instead.

Federal and State Fraud and Abuse Laws

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However, the civil penalty amounts are adjusted annually for inflation.

For civil penalties assessed after December 13, 2021, whose associated violations occurred after November 2, 2015, the civil penalty amount ranges between $11,803 and $23,607 per claim.

In addition, various states have enacted similar laws modeled after the False Claims Act that apply to items and services reimbursed under Medicaid and other state health care programs, and, in several states, such laws apply to claims submitted to any payor.

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These vendors are licensed or otherwise qualified to handle and dispose of such waste.

In addition, our advertising for laboratory services and LDTs that are not FDA-approved is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (FTC), as well as certain state laws.

Under the Federal Trade Commission Act, or FTC Act, the FTC is empowered, among other things, to prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce.

The FTC has very broad enforcement authority, and failure to abide by the substantive requirements of the FTC Act and other consumer protection laws can result in administrative or judicial penalties, including civil penalties, injunctions affecting the manner in which we would be able to market services or certain products in the future, or criminal prosecution.

Change in Fiscal Year

Effective January 1, 2021, we changed our fiscal year end from the last day of June to a calendar fiscal year.

The six month period that commenced on July 1, 2020 and ended on December 31, 2020 was a transition period and is referred to in this Annual Report on Form 10-K as the "transition period." References in this Annual Report on Form 10-K to “fiscal year” refer to years ended June 30th or December 31st, as applicable.

Available Information

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Our telephone number is (801) 584-3600 and our website address is www.myriad.com .

We make available free of charge through the Investor Information section of our website our Code of Conduct, our Audit and Finance Committee and other committee charters and our other corporate governance policies, as well as our Annual and Transition Reports on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission.

We make available free of charge through the Investor Relations section of our website our Code of Conduct, our Audit and Finance Committee and other committee charters and our other corporate governance policies, as well as our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission.

The Securities and Exchange Commission maintains an internet site ( http://www.sec.gov ) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the Securities and Exchange Commission.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business