What changed in this filing

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Item 1. Business

2024-02-28 compared with 2023-03-01 · 172 added, 143 removed, 444 unchanged (42% of the section changed)

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We are a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all.

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

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

Our Business Strategy

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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.

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.

Our focus is on innovation and growth in three key areas where we have specialized products, capabilities, and expertise:

Oncology, Women's Health, and Pharmacogenomics.

The pillars of our long-term growth strategy are founded on investments in science and innovation, technology-enabled operations, an elevated customer experience, strong commercial execution, and scalable operations.

We believe our path to continued growth is driven by articulating our clinical differentiation, raising awareness with patients who we believe would benefit from our testing products, and innovation that improves clinical outcomes, ease of use, and access.

By investing in tech-enabled commercial tools, new laboratory facilities, advanced automation, and standardized processes and technology, we believe we will be able to reduce complexity and cost, while enhancing our ability to scale and grow.

We plan to expand some of our current products, such as our Foresight Universal Plus Test, which is an expanded carrier screening test that we anticipate launching in the second half of 2024.

We also plan to launch new products, such as FirstGene, Precise Liquid, and Precise minimal residual disease, 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.

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.

Our tests are generally 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, identify factors which could lead to serious conditions in pregnancy, or provide other prenatal insights.

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.

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

Women's Health:

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

Mental Health:

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

Pharmacogenomics:

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

Oncology Women's Health Pharmacogenomics

MyRisk MyRisk GeneSight

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DNA sequencing test for assessing the risks for hereditary cancers.

Our MyRisk test is designed to determine a patient’s hereditary cancer risk for breast, ovarian, colorectal, endometrial, melanoma, pancreatic, prostate, and gastric cancers.

Our MyRisk test is designed to determine a patient’s hereditary cancer risk for breast, ovarian, uterine, renal, colorectal, endometrial, melanoma, pancreatic, prostate, skin and gastric cancers.

The test analyzes 48 separate genes to look for deleterious mutations that put a patient at a substantially higher risk than the general population for developing one or more of these cancers.

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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 assessment of the 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 to provide 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.

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

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

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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.

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.

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

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Prequel uses AMPLIFY™ technology that raises NIPS test performance most significantly for the types of patients who have traditionally had test failures on standard NIPS tests due to certain clinical factors.

AMPLIFY is the only NIPS technology that substantially reduces low fetal fraction test failures in order to allow for equity in care across all patients, regardless of body mass index (BMI), race, or ethnicity.

AMPLIFY is a NIPS technology that substantially reduces low fetal fraction test failures in order to allow for equity in care across all patients, regardless of body mass index (BMI), race, or ethnicity.

Foresight ® Carrier Screen:

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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.

Research has also 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.

a non-invasive blood test that predicts the gender of a fetus as early as six weeks of gestation with 99% accuracy.

Innovative cell free DNA technology and precise algorithms in the SneakPeek test are used to screen for a single, Y chromosome marker in the maternal 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:

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

Genesight covers over 60 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 in major depressive disorders, patients were more likely to respond to treatment compared to standard of care.

Using DNA gathered from 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.

Sales and Marketing

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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.

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.

For example, in 2023, we formalized a national account focus in our Oncology and Women's Health products to address the needs of our largest accounts who are dealing with population health and value-based care decisions, while our field sales teams remained focused on core customers across channels.

We continue to expand and strengthen our inside sales team with improved segmentation and territory alignment and by expanding our inside sales team to cover additional products.

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

We believe inside sales can be more cost effective in terms of customer acquisition costs.

We believe we will be better able to execute on our strategies and fulfill our mission by engaging with providers and patients by meeting them when they are in the consumer or patient journey.

Research and Development

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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 embed these biomarkers along with relevant clinical information in complex, proprietary tests that we believe 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 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.

For example, in 2023 we completed analytical validation of FirstGene, a new product that is designed to report maternal and fetal carrier status, fetal aneuploidy risk, and Rhesus D antigen (RhD) status using a single maternal blood draw during pregnancy.

Also in 2023, we achieved enrollment targets for a FirstGene prospective clinical validation study.

We completed the development of, and launched, a research-use only minimum residual disease (MRD) product, and initiated study partnerships with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center.

We also launched a prospective study, MONITOR-Breast, that we expect will generate evidence of the clinical validity of our MRD testing product.

For the years ended December 31, 2023, 2022, and 2021, we incurred research and development expense of $88.7 million, $85.4 million, and $81.9 million, respectively.

Industry and Competition

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• 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 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;

• broader, more innovative use of large data sets and analytics;

• increasing adoption of biomarker laws on a state-by-state basis, which we expect will result in more growth and adoption of genetic testing by clinicians and acceptance by local reimbursement agencies;

• 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.

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.

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 our 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.

To measure our success in driving towards a strong and friction-less experience for our patients and clinicians, we periodically conduct an internal Net Promoter Score survey with current users of our products.

We have maintained a very healthy score since the implementation of the program in 2022, which gives us a strong benchmark to continue to work against as we strive to improve and innovate.

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.

Our competitors in the oncology market include Invitae Corporation, Ambry Genetics Corporation, Natera, Inc., Foundation Medicine, Inc, Caris Life Sciences, Tempus, Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, and other commercial and academic laboratories.

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 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.

For example, in the second quarter of 2023, we added Folate Receptor Alpha (FRα) to our Precise Oncology Solutions offering to expand treatment options for women living with ovarian cancer.

FRα establishes patient eligibility for ELAHERE® (“mirvetuximab soravtansine-gynx”), the only FDA-approved drug indicated for patients who are FRα-positive and resistant to platinum-based chemotherapy.

FRα is a newly recommended biomarker test included in the National Comprehensive Cancer Network treatment guidelines for ovarian cancer.

Additionally, in the fourth quarter of 2023, we launched the Myriad Collaborative Research Registry™ (MCRR).

The MCRR includes new data across germline and tumor testing results from our cancer products on more than one million patients.

The latest enhancements make the MCRR freely available for research use and supports transparent clinical data sharing to advance the field.

In late 2024, we also plan to add a new liquid biopsy therapy selection test called Precise Liquid to the comprehensive Precise Oncology Solutions offering.

The test is a comprehensive genomic profiling test that may serve as a first-line offering or as a reflex test if the solid tumor is insufficient, and it will allow blood for therapy selection at diagnosis and in the metastatic setting.

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.

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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.

Our competitors include Natera, Inc., Ambry Genetics Corporation, Laboratory Corporation of America Holdings, a subsidiary of Konica Minolta Inc., Quest Diagnostics Incorporated, 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.

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

We have recently expanded our physical footprint by growing our SneakPeek product presence into the retail pharmacy setting, which we believe is a strong opportunity for us to target consumers with our prenatal portfolio of offerings beyond directly through physicians.

We also plan to improve customer experience with our online unified ordering portal to engage with patients and physicians, our cost estimators across our product lines, our remote product-specific 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.

FirstGene combines the power of our Prequel NIPS with AMPLIFY technology on a whole exome platform 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 first half of 2025, 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 have previously announced our support for the 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 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 may impact patient response to antidepressants and other drugs.

Foresight Universal Plus is an expanded carrier screening test with the same technology that differentiates Foresight’s clinical utility in carrier screening.

We plan to launch this test in the second half of 2024 in anticipation of the expansion of American College of Obstetricians and Gynecologists (ACOG) guidelines, which we anticipate will be expanded to include 274 genes.

This new test will also include merged couple reporting to fully realize the value of this test to those individuals who are thinking about family planning.

Pharmacogenomics

In Pharmacogenomics, 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.

Our competitors in this market include Genomind, Tempus, 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.

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We have historically experienced seasonality in our testing business.

The quarter ended December 31st is generally strong as we typically experience an increase in volumes from patients who have met their annual insurance deductible.

Conversely, in the quarter ended March 31st we typically experience a decrease in volumes due to the annual reset of patient deductibles.

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

In the quarter ended March 31, we typically experience a decrease in volumes due to the annual reset of patient deductibles.

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

Conversely, the quarter ended December 31 is generally strong as we typically experience an increase in volumes from patients who have met their annual insurance deductible.

In the fiscal year ended December 31, 2023, we did not experience seasonality to the same extent we have in prior years.

For example, in the quarter ended September 30, 2023, we did not see the customary impact from the summer season as volumes decreased less than one percent in comparison to the quarter ended June 30, 2023.

Historical patterns of seasonality may not continue in future years.

Human Capital Management

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.

As a leader in genetic testing and precision medicine, our mission is to advance health and well-being for all by helping people 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.

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As of December 31, 2023, we have approximately 2,700 full-time equivalent employees.

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

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

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

One of our key human capital metrics is employee turnover.

For the year ended December 31, 2023, our global voluntary employee turnover rate was 9%.

Diversity, Equity and Inclusion (DE&I) :

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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 have seven employee-led resource groups (ERGs) that represent and support diverse communities in our workforce.

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

As of December 31, 2023, 63% of our employees were women, and women held 42% 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.

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Our compensation program is designed to attract and reward talented individuals who possess the skills necessary to support our business objectives, assist in the achievement of our strategic goals and create long-term value for our stockholders.

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, 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.

We also provide free mental health resources for employees and their dependents.

We provide competitive salaries, stock ownership opportunities, and 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, parental leave, family formation benefits, employee assistance programs, including free mental health resources for employees and their dependents, community outreach programs, training and development opportunities, and wellness programs.

Career Development and Training :

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Oversight and Management :

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.

We regularly conduct surveys to obtain 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.

Our most recent survey shows how these intentional efforts are making a difference as 86% of our employees rated us as a Great Place to Work ®.

Social Responsibility and Community :

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The corporate social responsibility programs at Myriad align with a clearly defined set of strategic priorities including:

• Philanthropy :

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 :

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 :

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, we have created a Green Team to foster environmental and sustainability stewardship.

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

• Scholarship :

• Philanthropy :

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

Environmental and Sustainability

We strive to do business in ways that protect both the health and safety of our employees and the world in which we operate by establishing, promoting, maintaining, and improving a culture of sustainability and environmental responsibility.

In order to achieve our objectives, we have increased our focus on environmental and sustainability efforts by adopting a Sustainability Strategy and Vision Statement that we are working towards fully implementing.

In order to achieve our objectives, we have increased our focus on environmental and sustainability efforts that we are working towards fully implementing.

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 develop and maintain sustainable business practices.

We have also formed an internal Environmental, Social, and Governance (ESG) Committee in an effort to develop and maintain sustainable business practices.

In connection with our 2022 Environmental, Social and Governance Report, we completed our first carbon inventory, measuring our Scope 1 and Scope 2 emissions from the use of our laboratories and office spaces during the year ended December 31, 2022.

Energy and emissions data was captured for select buildings with the largest footprint and used to model emissions from our remaining operations where limited or no data was available.

For more information on our approach to sustainability, please refer to our 2022 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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Test Patent Assets Expiration Claims

Prolaris Prostate Cancer Prognostic Test We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S.

Prolaris Prostate Cancer Prognostic Test We own one or more issued patents and pending patent applications in the U.S.

and other jurisdictions relating to Prolaris testing.

These issued U.S.

patents have terms expected to begin expiring in 2030.

These pending and issued patents have terms expected to begin expiring in 2030.

Claims relating to biomarkers, kits, systems and methods for detecting, diagnosing, prognosing and selecting therapy for prostate cancer.

EndoPredict Breast Cancer Prognostic Test We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S., Europe and other jurisdictions relating to EndoPredict ® testing.

These issued patents have terms expected to begin expiring in 2031.

EndoPredict Breast Cancer Prognostic Test We own one or more issued patents and pending patent applications in the U.S.

and other jurisdictions relating to EndoPredict testing.

These pending and issued patents have terms expected to begin expiring in 2031.

Claims relating to biomarkers, kits, systems and methods for prognosing and selecting therapy for breast cancer.

MyChoice CDx Companion Diagnostic Test We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S.

MyChoice CDx Companion Diagnostic Test We own or hold a license to one or more issued patents and pending patent applications in the U.S.

and other jurisdictions relating to MyChoice CDx testing.

These issued patents have terms expected to expire in 2031.

These pending and issued patents have terms expected to expire in 2031.

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

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.

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

and other jurisdictions relating to GeneSight testing.

These issued patents have terms expected to begin expiring in 2024.

Claims relating to biomarkers, kits, systems and methods for detecting single nucleotide polymorphisms and selecting and/or optimizing therapy based on such detection.

Foresight Carrier Screen We own or hold an exclusive license to one or more issued patents and pending patent applications in the U.S.

These pending and issued patents have terms expected to begin expiring in 2024.

Claims relating to biomarkers, systems and methods for detecting single nucleotide polymorphisms and selecting and/or optimizing therapy based on such detection.

Foresight Carrier Screen We own one or more issued patents and pending patent applications in the U.S.

and other jurisdictions that relate to laboratory and informatic methods used to enhance Foresight testing.

These issued patents have terms expected to begin expiring in 2032.

These pending and issued patents have terms expected to begin expiring in 2032.

Claims relating to systems and methods for detecting genetic sequences.

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and other jurisdictions that relate to laboratory and informatic methods used to enhance Prequel testing.

These issued patents have terms expected to begin expiring in 2032.

These pending and issued patents have terms expected to begin expiring in 2032.

Claims relating to systems and methods for detecting genetic sequences.

MRD We own one or more issued patents and pending patent applications in the U.S.

or other jurisdictions relating to MRD testing.

These pending and issued patents have terms expected to begin expiring in 2026.

Claims relating to systems and methods for preparing enriched DNA fractions, detecting circulating tumor DNA, and identifying tumor variants

We intend to seek patent protection in the United States and major foreign jurisdictions for these and other inventions which we believe are patentable and where we believe our interests would be best served by seeking patent protection.

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Entity Subject Royalties Expiration

Mayo Foundation for Medical Education and Research (Mayo) Exclusive world-wide license to certain rights of Mayo in intellectual property relating to our GeneSight testing.

We pay Mayo a royalty based on net sales of our GeneSight test.

We do not anticipate that this license will expire until 2024.

University of Texas M.D.

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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.

License runs for the term of the UTMDACC agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the UTMDACC agreement.

Mayo Foundation for Medical Education and Research (Mayo) Exclusive world-wide license to certain rights of Mayo in intellectual property relating to our GeneSight testing.

We pay Mayo a royalty based on net sales of our GeneSight test.

License runs for the term of the Mayo agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the Mayo agreement.

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

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

License runs for the term of the CMCC agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the CMCC agreement.

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

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.

License runs for the term of the INSERM agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the INSERM agreement.

Illumina, Inc.

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We pay Illumina a royalty based on the volume of Prequel testing administered by us.

License runs for the term of the Illumina agreement and, in any event, expires upon expiration of the last to expire patent right covered by the Illumina agreement.

License runs for the term of the Illumina agreement and, in any event, expires or may be terminated upon expiration of the last to expire patent right covered by the Illumina agreement.

Governmental Regulation

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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.

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.

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

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

If one of our laboratories fails to achieve a passing score on a proficiency test, then it may lose its right to perform testing.

Further, failure to comply with other proficiency testing regulations, such as the prohibition on referral of a proficiency testing specimen to another laboratory for analysis, can result in revocation of the laboratory’s CLIA certification.

As a condition of CLIA certification, each of our laboratories is subject to survey and inspection every other year, in addition to being subject to additional random inspections.

As a condition of CLIA certification, each of our clinical laboratories is subject to survey and inspection every other year, in addition to being subject to additional random inspections.

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 rather than CMS inspections.

Because our clinical 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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In the United States, in vitro diagnostic (IVD) products are subject to regulation by the FDA as medical devices to the extent that they are intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.

They are subject to premarket review and post-market controls that will differ depending on how the FDA classifies a specific IVD, which is further defined in FDA’s implementing regulations as a device intended for use in the collection, preparation, and examination of specimens taken from the human body.

They are subject to premarket review and post-market controls that will differ depending on how the FDA classifies a specific IVD, which is further defined in the FDA’s implementing regulations as a device intended for use in the collection, preparation, and examination of specimens taken from the human body.

For certain types of tests known as laboratory developed tests (LDTs)—which are in vitro diagnostic tests that are designed, manufactured and used within a single laboratory—FDA regulation is less clear than for IVDs.

Historically, FDA has exercised enforcement discretion for LDTs, which means that FDA generally has not enforced premarket review and other applicable FDA requirements.

Historically, the FDA has exercised enforcement discretion for LDTs, which means that the FDA generally has not enforced premarket review and other applicable FDA requirements.

However, as LDTs have increased in complexity, the FDA has taken a risk-based approach to their regulation.

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

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.

Following several years of inaction by Congress on this issue, the FDA issued a proposed rule in October 2023 to regulate LDTs under the current medical device framework and proposed to phase out the current enforcement discretion policy;

the public comment period ended in early December 2023.

The FDA’s proposal envisions that the LDT enforcement policy phase-out process would occur in gradual stages over a total period of four years, with premarket approval applications for high-risk tests to be submitted by the 3.5-year mark, although more details are expected to be provided with the upcoming final rule.

The likelihood of the FDA finalizing the proposed rule in April 2024 (as is currently projected), as well as potential litigation challenging the agency’s authority to take such action, is uncertain at this time.

Affected stakeholders continue to press for a comprehensive legislative solution to create a harmonized paradigm for oversight of LDTs by both the FDA and CMS, instead of implementation of the proposed FDA administrative action, which may be disruptive to the industry and to patient access to certain diagnostic tests.

In the absence of a comprehensive legislative solution, however, the FDA has indicated its intent to finalize this rulemaking.

Ensuring compliance with the agency’s future implementation plans for bringing LDTs under the medical device framework is expected to require significant time, financial resources, and other resources, including specialized personnel, on the part of clinical laboratories engaged in developing and offering such diagnostic tests.

Separately, members of Congress have been working with stakeholders for several years on a possible bill to reform the regulation of in vitro clinical tests including LDTs.

For example, as drafted and re-introduced for consideration by the current Congress, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would codify into law the term as "in vitro clinical test" (IVCT) and establish a new regulatory framework for the review and oversight of IVCTs separate and apart from the medical device framework under the Food, Drug and Cosmetic Act (FDCA).

The new IVCT product category would include products currently regulated as IVDs, in addition to LDTs.

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, and includes a proposed future user fee program for IVCTs.

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.

If enacted, 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 laboratory 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 would also establish 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 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.

Until the FDA finalizes LDT regulations through its recently initiated notice-and-comment rulemaking process, or the VALID Act or other legislation is passed reforming the federal government’s current regulatory approach to LDTs, it is unknown how the FDA may regulate our LDT products in the future or what testing and data may be required to support clearance or approval for such products.

In Vitro Diagnostics as Medical Devices

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Clinical trials are almost always required to support a PMA application and are sometimes required for a De Novo classification request or a 510(k) premarket notification.

Further, Congress recently amended the FDCA to require sponsors of most clinical studies of investigational medical devices intended to support marketing authorization to design and submit a diversity action plan for such clinical trial.

The action plan must include the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them.

The FDA may grant a waiver for some or all of the requirements for a diversity action plan.

It is unknown at this time how the diversity action plan may affect clinical trial planning or what specific information the FDA will expect in such plans, but if the FDA objects to a sponsor’s diversity action plan or otherwise requires significant changes to be made, it could delay initiation of the relevant clinical trial.

If the FDA determines that the applicant’s device is substantially equivalent to the identified predicate device(s), the agency will issue a 510(k) clearance letter that authorizes commercial marketing of the device for one or more specific indications for use.

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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.

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.

The FDA's De Novo regulations became effective on January 3, 2022.

Among other things, if the manufacturer seeks reclassification into Class II, the classification request must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.

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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 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.

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 final 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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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.

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 period until its original effective date of May 26, 2022, plus some transition provisions for IVDs already on the market.

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.

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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.

Under the IVDR, Class C IVDs require assessment by a Notified Body for certification and audit of the manufacturer's quality management system (QMS) 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.

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

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 now be reviewed by the Notified Bodies.

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 QMS and Technical Documentation which will now be reviewed by the Notified Bodies.

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.

Due to multiple challenges to IVD manufacturers 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 January 25, 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.

On January 23, 2024, the European Commission announced proposals to further extend the IVDR transition provisions in order to ensure availability of IVDs.

Under the proposal, the transition period in the IVDR will be extended to December 2028 for Class C high individual and/or moderate public health risk devices.

Medical devices certified under the Directive may benefit from the extension provided they meet certain conditions (i.e., continue to comply with the Directive, not be the subject of significant changes on design or intended purpose, etc.).

The proposal needs to be adopted by the European Parliament and Council before it enters into force.

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 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.

However, the UK remains broadly aligned with the EU Directive.

As described in these provisions, MHRA will continue to recognize CE marks within Great Britain, which is defined as England, Scotland and Wales, up to July 2030 for certain devices in order to align with EU transition periods.

Companies wishing to place IVDs on the UK market are also required to register with MHRA and have to appoint a UK Responsible Person to manage their compliance efforts in the UK, but are still able to sell CE-IVD marked products in Great Britain.

From approximately July 2025, new legislation will apply in the UK to better align with the IVDR and other international requirements, including requirements for the new marking called a UK Conformity Assessed mark (UKCA).

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.

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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.

Some of those changes will affect IVDs, including the ability to qualify for fast track designation.

The first round of changes to Japan’s Pharmaceuticals and Medical Devices Act took effect September 1, 2020 and August 2021.

The revision in May 2022 created the fast track approval of IVDs conditional or time-limited approval in emergency situations when the efficacy of medical product is presumed, subject to safety confirmation.

The Ministry of Health, Labour and Welfare will start discussion in May 2024 on the upcoming revision of the Pharmaceuticals and Medical Devices Act, which includes a reform of sales system of the medical products which may include IVDs.

Additional International Regulation

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

Reports must be made to affected individuals and to the Secretary and, in some cases depending on the size of the breach, they must be reported through local and national media.

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

Reports must be made to affected individuals and to the Secretary and, in some cases depending on the size and impact of the breach, they must be reported through local and national media.

Breach reports can lead to investigation, enforcement, civil monetary penalties and civil litigation, including class action lawsuits and enforcement by state authorities as well as significant reputational harm.

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.

However, even if we take steps to comply with HIPAA, we may be subject to breaches caused by human error or external threat actors, 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 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.

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

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Manufacturers must report data for the previous calendar year by the 90th day of the then-current calendar year.

CMS then publishes the data on a publicly available website no later than June 30th.

CMS then publishes the data on a publicly available website no later than June 30.

There are also state “sunshine” laws that require manufacturers to provide reports to state governments on pricing and marketing information.

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Reimbursement and billing for diagnostic services is highly complex.

Laboratories must bill various payors, such as private third-party payors, including managed care organizations (MCO), and state and federal health care programs, such as Medicare and Medicaid, and each may have different billing requirements.

Laboratories must bill various payors, such as private third-party payors, including managed care organizations (MCOs), and state and federal health care programs, such as Medicare and Medicaid, and each may have different billing requirements.

Additionally, the audit requirements imposed by these payors, as well as our internal compliance policies and procedures, add further complexity to the billing process.

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Accordingly, if newly developed tests receive Medicare coverage in the future, the reimbursement rate we receive for such tests may be affected by payment rates made by private payors for such tests.

On December 20, 2019, the President signed the Further Consolidated Appropriations Act, which included the Laboratory Access for Beneficiaries Act (LAB Act).

The LAB Act delayed until the first quarter of 2021 reporting of payment data under PAMA for CDLTs that are not ADLTs.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which Congress passed in March 2020, again delayed the reporting by an additional year, this time until the first quarter of 2022.

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.

Since December 2019, Congress has passed a series of laws to modify PAMA’s statutory requirements related to the data reporting period and phase-in of payment reductions under the CLFS for CDLTs that are not ADLTs.

Most recently, the Further Continuing Appropriations and Other Extensions Act of 2024 (Pub.L.

118-22, enacted on November, 16, 2023) further delayed the reporting requirement as well as the application of the 15% phase-in reduction.

Under these statutory provisions, the next data reporting period for CDLTs that are not ADLTs will be January 1, 2025 through March 31, 2025, and will be based on the most recent data collection period of January 1, 2019 through June 30, 2019.

After this data reporting period, the three-year data reporting cycle for these tests will resume (e.g., 2028, 2031, etc.).

CMS’s methodology under PAMA (as well as the willingness of commercial insurers to recognize the value of diagnostic testing and pay for that testing accordingly) renders commercial insurer payment levels even more significant.

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For example, for 2018 through 2020, a test price could not be reduced by more than 10% per year.

Reductions for 2023 through 2025 are limited to 15%.

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 same series of laws modified the phase-in of payment reductions resulting from private payor rate implementation so that a 0.0 percent reduction limit was applied for calendar years 2021 through 2023, as compared to the payment amounts for a test the preceding year.

The Further Continuing Appropriations and Other Extensions Act of 2024 further applied a 0.0 percent reduction limit for calendar year 2024.

Consequently, payment may not be reduced by more than 15 percent per year for calendar years 2025 through 2027 as compared to payment amount established for a test the prior year.

The subsequent data reporting period for CDLTs that are not ADLTs will occur in three-year cycles, with the next cycle beginning in 2025.

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The qui tam provisions of the False Claims Act allow a private individual to bring an action on behalf of the federal government and to share in any amounts paid by the defendant to the government in connection with the action.

Penalties include payment of up to three times the actual damages sustained by the government, plus civil penalties of between $5,500 and $11,000 for each false claim, as well as possible exclusion from federal health care programs.

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

Penalties include payment of up to three times the actual damages sustained by the government, plus significant civil penalties for each false claim, as well as possible exclusion from federal health care programs.

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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This includes requirements to develop and implement multi-faceted programs to protect workers from exposure to blood-borne pathogens, including preventing or minimizing any exposure through needle stick injuries.

This also includes requirements to ensure employees are informed of hazardous chemicals in the workplace and provide expectations for the safe handling of hazardous chemicals.

For purposes of transportation, some biological materials and laboratory supplies are classified as hazardous materials and are subject to regulation by one or more of the following agencies:

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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.

In addition, our advertising for laboratory services using FDA-cleared or approved IVDs as well as services using 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

We are a Delaware corporation with our principal executive offices located at 320 Wakara Way, Salt Lake City, Utah 84108.

We are a Delaware corporation with our principal executive offices located at 322 North 2200 West, Salt Lake City, Utah 84116.

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

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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