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Item 1. Business

2026-02-24 compared with 2025-02-28 · 202 added, 173 removed, 465 unchanged (45% of the section changed)

Overview and Mission

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

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

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

Myriad Genetics is a leading molecular diagnostics and precision medicine company committed to advancing health and well-being for all.

We develop and commercialize molecular tests that help patients and providers uncover genetic insights.

Our tests assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care, support earlier detection, enable more precise treatment and contribute to lowering healthcare costs.

Our Business Strategy

Personalize molecular data and digital and virtual consumer trends are converging to transform traditional models of care.

We believe that engaging with providers and patients throughout their consumer or patient journey will better enable us to execute our strategies and fulfill our mission.

Personalized molecular data and digital and virtual consumer trends are converging to transform traditional models of care.

We believe that engaging with providers and patients throughout their consumer and patient journey will better enable us to execute our strategies and fulfill our mission.

We believe there are significant growth opportunities in addressing the pressing healthcare needs of patient populations through innovative molecular diagnostic testing and precision medicine solutions and services.

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.

Our long-term growth strategy is built on investments in science and innovation, technology-enabled operations, an enhanced customer experience, strong commercial execution, and scalable operations.

To drive continued growth, we plan to accelerate electronic medical records (EMR) integrations, expand our sales channels, including into large health systems, cross sell our portfolio of testing products to providers, enhance our testing products within medical guidelines, demonstrate our clinical differentiation and value compared to the standard of care, and optimize our revenue cycle processes.

For example, in June 2024, we launched the Universal Plus Panel to our Foresight Carrier Screen Test, which is an expanded carrier screening test.

We also continue to invest in clinical evidence development to support the growth of our existing products and launch of new products, such as FirstGene, Precise Liquid, and Precise molecular residual disease (MRD) which we expect will help us continue to grow.

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

In addition, by investing in technology-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.

For example, in early 2025, we plan to complete the transition of all of our laboratory activities to our next generation laboratory facilities, which we believe will improve the efficiency of our operations.

Our long-term growth str ategy is buil t on leveraging our differentiated strengths, including our reputation for trusted high-quality tests and customer service, and our established, extensive commercial reach in community medicine.

Our strategy also leverages invest ments in science and innovation, technology-enabled operations, an enhanced customer experience, strong commercial execution, and scalable operations.

Our strategic intent is to accelerate profitable growth by focusing on (i) providing a comprehensive testing menu for the Cancer Care Continuum (CCC) market with a priority for high growth applications;

(ii) growing our Prenatal Health and Mental Health revenues at or above market growth;

and (iii) delivering sustained profitable growth through financial and operational discipline and leveraging our operating model.

Under this strategy, we plan to leverage our strong scientific foundation, deep clinical partnerships, and technology-enabled capabilities to expand adoption of our testing portfolio and integrate our precision medicine solutions more deeply into clinical workflows across the Cancer Care Continuum, Prenatal Health, and Mental Health.

Cancer remains one of the most prevalent diseases, with more than two million new cases diagnosed, and more than eighteen million survivors, in the United States in 2025.

Myriad is a pioneer in DNA based cancer diagnostic testing, and a trusted leader in hereditary cancer testing across eleven of the most commonly occurring cancer types including breast, ovarian, colorectal, prostate, lung and skin.

We are also a leader in cancer therapy selection with our Homologous Recombination Deficiency (HRD) test and are planning to strengthen our portfolio of comprehensive genomic profiling tests through product development and partnerships.

We see molecular residual disease (MRD) testing as a significant opportunity for patient impact and revenue growth.

We believe Myriad’s ultra-sensitive Precise MRD offering, combined with our growing portfolio of other relevant diagnostic tests that are a common part of cancer care and, our commercial leadership in serving community medicine, will enable us to establish and grow a meaningful MRD business over the coming years.

As part of our Cancer Care Continuum strategy, we also plan to expand the number of biopharma partners we serve with services including biomarker identification and validation, companion diagnostic test development and regulatory registration, as well as companion diagnostic test commercialization.

Complementing our own capabilities with partnerships that enable us to bring compelling solutions to market more quickly is an important part of our strategy.

In early 2025, we entered into a strategic collaboration with PATHOMIQ, Inc.

pursuant to which we obtained exclusive U.S.

licen sing rights to PATHOMIQ’s AI-enabled diagnostic platform, PATHOMIQ_PRAD, to enhance our oncology portfolio and offer AI-driven prognostic and predictive solutions for prostate cancer care.

In September 2025, we entered into a strategic collaboration with SOPHiA GENETICS S.A.

to develop a global liquid biopsy companion diagnostic solution.

We continue to invest in clinical evidence development to support the growth of our existing products and launch of new products, such as FirstGene and Precise MRD.

We believe these investments in product innovation position us to expand our addressable markets and differentiate our portfolio of testing solutions.

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

In addition, by investing in technology-enabled commercial tools, 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.

In 2025, we completed the transition of our laboratory operations to our next-generation laboratory facilities, which are designed to enhance automation, reduce turnaround time, and improve cost efficiency across our testing portfolio.

We believe these improvements, combined with our ongoing operational initiatives, position us to achieve greater scalability and reduce operating expenses as a percentage of revenue over time.

We are committed to making molecular testing accessible and actionable for patients and providers while driving long-term growth and profitability.

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

Clarifying cancer risk and 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 differentiated genetic insights and prenatal solutions for women of all ancestries, assessing cancer risk, and offering leading health and wellness for expectant parents and their babies with genetic insights and prenatal solutions.

Pharmacogenomics:

Providing differentiated genetic insights and prenatal solutions for women of many ancestries, assessing cancer risk, and offering leading health and wellness for expectant parents and their babies with genetic insights and prenatal solutions.

Mental Health:

Leveraging pharmacogenomics to help clinicians understand how genetics may impact patient metabolism and response to antidepressants and other mental health medications.

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

Oncology Women's Health Pharmacogenomics

Oncology Women's Health Mental Health

MyRisk MyRisk GeneSight

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MyChoice CDx Foresight

Prolaris SneakPeek

Prolaris FirstGene

EndoPredict SneakPeek

Precise Tumor

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The test analyzes 63 separate genes to look for deleterious mutations that put a patient at a substantially higher risk than the general population for developing 11 different types of hereditary cancer.

All 48 genes in the panel are well documented in clinical literature for the role they play in hereditary cancer and have been shown to have actionable clinical interventions for the patient to facilitate earlier cancer detection, lower disease risk, or reduce risk of cancer recurrence.

All 63 genes in the expanded panel are well documented in clinical literature for the role they play in hereditary cancer and have been shown to have actionable clinical interventions for the patient to facilitate earlier cancer detection, lower disease risk, or reduce risk of cancer recurrence.

The MyRisk Genetic Test Result and MyRisk Management Tool ® summarize medical society guidelines for managing a patient with a genetic mutation in view of their personal and family history of cancer.

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 to provide a personalized five-year and lifetime assessment of the risk of developing breast cancer—regardless of ancestry.

MyRisk also includes RiskScore ® , validated across all ancestries with expanded genomic markers, which incorporates clinical risk factors, family history, and ancestry-informed genetic markers to provide a personalized five-year and lifetime assessment of breast cancer risk.

BRACAnalysis CDx ® Germline Companion Diagnostic Test :

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.

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

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

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.

We remain the only laboratory with an FDA-approved germline BRCA companion diagnostic test for breast cancer, with additional approvals in ovarian, pancreatic, and advanced prostate cancers.

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 :

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.

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

This FDA-approved test, with clinical utility validated in more than 20,000 patients across multiple tumor types , helps provide information on the magnitude of benefit for PARP inhibitor therapy.

HRD status is determined using two independent methods:

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

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

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

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Our Prolaris test is a gene expression assay that assesses whether a patient is likely to have a slow growing, indolent form of prostate cancer that can be safely monitored through active surveillance, or a more aggressive form of the disease that may warrant aggressive intervention such as a radical prostatectomy or radiation therapy.

The Prolaris test was developed to improve physicians’ ability to predict disease outcome and thereby to optimize patient treatment.

The Prolaris test is designed to improve physicians' ability to predict disease outcome and thereby to optimize patient treatment.

EndoPredict ® Breast Cancer Prognostic Test :

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The EndoPredict laboratory developed test is a next-generation RNA expression test used to determine which women with breast cancer may benefit from chemotherapy.

EndoPredict predicts the likelihood of metastases to help guide treatment decisions for chemotherapy and extended endocrine therapy.

EndoPredict predicts the likelihood of metastases to help guide treatment decisions for individuals undergoing chemotherapy and extended endocrine therapy.

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.

In August 2024, we divested the EndoPredict business to Eurobio Scientific.

As part of the transaction, we licensed the rights from Eurobio to continue to sell EndoPredict as a laboratory developed test outside of the European Union and we licensed to Eurobio the rights to sell Prolaris in vitro diagnostic kits outside the U.S.

We currently expect to discontinue sales of EndoPredict in the United States during the first half of 2026.

Precise Tumor ® Molecular Profile Test :

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This hybrid-capture DNA- and RNA-based test detects Single-Nucleotide Variants (SNV), Insertion-Deletion Mutations (INDELs), Copy Number Variants (CNV), splice variants and fusions in solid tumors.

In 2025, the assay was enhanced with expanded variant coverage, improved RNA capture for more sensitive fusion and splice variant detection, and upgraded bioinformatics for ultra-low allele frequency detection.

Additional immune and therapy-response biomarkers, including tumor mutational burden and microsatellite instability, were incorporated, and reporting was refined to reflect the latest clinical evidence, further supporting precision oncology treatment decisions.

Precise MRD ™ Test:

A tumor-informed test that can be used to monitor circulating tumor DNA (ctDNA) levels throughout a patient’s clinical cancer care, with applications in the neoadjuvant, adjuvant, and surveillance settings across cancer types.

Using whole-genome sequencing to create a personalized assay for each patient's tumor, this test enables ultrasensitive detection of ctDNA down to one part per million.

Prequel ® Prenatal Screen :

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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.

FirstGene ® Multiple Prenatal Screen:

a comprehensive prenatal genetic risk assessment test currently available through early access in a large clinical study.

The FirstGene screen combines multiple testing modalities into a single assay, providing guideline-driven testing without the need for a paternal sample.

The test evaluates fetal aneuploidy risk (including trisomies 13, 18, 21, sex chromosome aneuploidies, and 22q11.2 microdeletion), fetal recessive carrier and affected status (including cystic fibrosis, spinal muscular atrophy, Hb Bart disease, beta globin-related hemoglobinopathies, Tay Sachs disease, congenital disorder of glycosylation, PMM2-related disorder, medium chain acyl-CoA dehydrogenase deficiency, Canavan disease, Smith-Lemli-Opitz syndrome, and phenylalanine hydroxylase deficiency), pregnant person carrier status (including fragile X syndrome), and RhD compatibility.

FirstGene’s assay is designed to deliver all four components concurrently, requiring fewer blood draws and providing a more complete fetal genetic risk assessment with high sensitivity (≥98.6%) and specificity (≥99.6%).

This test represents a significant expansion of Myriad’s prenatal testing portfolio.

SneakPeek ® Early Gender DNA Test :

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Sales and Marketing

We primarily sell our tests through our sales force and marketing efforts in the United States and Japan, while servicing additional global accounts via indirect sales channels.

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

We continuously optimize our sales and marketing channels by increasing digital marketing, leveraging direct to patient marketing, enhancing virtual sales tools to drive efficiency, and utilizing our inside sales team.

To create a seamless experience for providers and patients, we are expanding our footprint in EMRs across hospital systems and other providers.

This allows us to offer the ordering and reporting functionality that providers need in their clinical practice.

Additionally, this investment allows us to better cross-sell our portfolio of products, providing a comprehensive set of tests for providers to use with their patients.

Foundational to that effort includes improving our products within medical guidelines to deliver value compared to the standard of care, which we believe will also lead to guideline and reimbursement expansion.

We also focus on engaging with patients directly in establishing their family health history, assessing their eligibility for our products, and interpreting their test results.

We believe that by engaging with patients throughout their entire journey, we deliver a comprehensive experience that ultimately boosts sales.

In the long term, we are committed to building an end-to-end digital architecture to meet the needs of patients and providers, which we believe will drive volume growth.

We primarily sell our tests through our sales force and marketing efforts in the United States and Japan, while expanding our global reach through indirect channels and partnerships in Europe and Asia-Pacific.

We continue to optimize our marketing channels, including increasing our use of digital channels, direct-to-patient campaigns, personalized outreach through mobile platforms, and virtual sales tools.

Our investment in electronic medical records (EMR) integrations across hospital systems and provider networks has broadened our ordering and reporting functionality, enabling providers to seamlessly access our portfolio of tests.

In 2025, we expanded certain patient engagement initiatives, including family health history collection, eligibility assessment, and results interpretation across oncology, hereditary cancer, and emerging mental health pathways.

These efforts align with updated medical guidelines and reimbursement changes.

Foundational to our long-term strategy is the development of an end-to-end digital architecture that connects patients, providers, and payers.

We believe that this ecosystem will support patient access to treatment and certain companion diagnostic partnerships, driving sustainable volume growth and reinforcing our leadership in precision medicine.

Research and Development

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Our continued investment in R&D is designed to drive long-term value creation by delivering high-impact innovations that align with evolving healthcare needs.

As part of our long-term growth strategy, we plan to increase our investment in R&D in 2025 to drive innovation and new product development and enhance clinical evidence generation through clinical studies.

As part of our long-term growth strategy, we expect R&D investment in 2026 to increase with a focus on the Cancer Care Continuum, which will support innovation, new product development and clinical evidence generation through clinical studies.

These initiatives align with our commitment to improving diagnostic accuracy, expanding our test portfolio, and strengthening our position in precision medicine.

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In 2025, we made significant advancements in our R&D efforts, strengthening our portfolio of innovative diagnostic solutions:

• Earlier Prenatal Screening with Prequel

• Advancements in Molecular Residual Disease (MRD)

◦ During 2025, we received six new U.S.

patents covering technological innovations related to our high-definition, tumor-informed molecular residual disease (MRD) assay, Precise MRD.

◦ At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, we and our collaborators from the National Cancer Center Hospital East in Japan presented results from the MONSTAR-SCREEN 3 study, which reported 100 percent baseline sensitivity and highly sensitive detection of residual disease post-surgery.

◦ In September 2025, Lancet Oncology published a study describing the performance of Precise MRD in patients with oligometastatic clear-cell renal cell carcinoma.

• Prenatal and Reproductive Health

◦ In the second quarter of 2025, we initiated early access to the FirstGene Multiple Prenatal Screen through a multi-site study known as CONNECTOR, which we expect will support future commercial launch activities and expand our capabilities in the prenatal testing segment.

◦ We began offering Prequel, our prenatal cell-free DNA screen, at eight weeks of gestational age, compared to the previous availability at 10 weeks.

◦ Earlier prenatal screening with Prequel enables earlier risk assessment for fetal chromosomal abnormalities, allowing expectant parents and healthcare providers to make more informed decisions sooner.

• Expanded Carrier Screening with Foresight

◦ Increased the number of conditions screened by Foresight Universal Plus, our expanded carrier screen, to 272 genes.

◦ Aligned with ACMG recommendations and anticipated guidance from the American College of Obstetricians and Gynecologists, ensuring clinical relevance and broad adoption.

• Advancements in MRD Testing

◦ Completed and presented analytical assessments at multiple conferences demonstrating the exceptional sensitivity of Precise MRD, our research-use-only MRD product.

◦ We have partnered in several clinical validation studies in breast cancer and renal cancer with leading institutions, including:

▪ MD Anderson Cancer Center

▪ Memorial Sloan Kettering Cancer Center

▪ University of Rochester Medical Center

• Global Collaboration on MRD Research

◦ Began processing samples for MONSTAR-3, a prospective pan-cancer MRD study, led by collaborators at the National Cancer Center East in Japan.

◦ Supported the continued development of MRD as a potential tool for monitoring cancer recurrence and treatment response.

• Oncology and Companion Diagnostics

◦ In the third quarter of 2025, we announced a collaboration with SOPHiA GENETICS SA to co-develop a global liquid biopsy companion diagnostic (CDx) testing solution intended for use in biopharmaceutical clinical programs and precision oncology initiatives.

• Hereditary Cancer and Preventive Genomics

◦ Throughout 2025, we continued to expand EMR integrations and breast cancer risk-assessment programs to increase accessibility of hereditary cancer testing within broader clinical populations, including unaffected individuals.

◦ In November 2025, we added 15 clinically actionable genes to our MyRisk hereditary cancer test.

• Prostate Cancer and Artificial Intelligence Development

◦ We advanced development of an AI-enabled prostate cancer diagnostic test in collaboration with PATHOMIQ Inc., with an anticipated commercial launch of the test in the first half of 2026.

These strategic R&D investments and collaborations underscore our commitment to innovation, regulatory alignment, and improved clinical utility for our current and future testing products.

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Industry and Competition

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 costs.

Healthcare continues to evolve to be more patient-centered and value-based.

Patients, healthcare providers, payors, and health systems are increasingly leveraging the power of genetic insights, molecular diagnostics, and precision medicine to personalize care, improve access, and lower costs.

We believe key industry trends include the following:

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

• demand for high-quality, clinically validated diagnostics that support early detection and targeted treatment strategies;

• 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;

• rapid technological advancements in automation and sequencing platforms, enabling scalable models for diagnostic testing, reducing costs, and enhancing operational efficiency;

• enhancements from artificial intelligence to automate image analysis, prior authorization, laboratory testing, and data interpretation, designed to increase speed and accuracy of testing;

• 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 with academic and biopharma partners to advance companion diagnostics and serve patients with specific treatments based on their own genetic makeup and biology.

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

The ongoing market disruption in our sector also provides opportunities for market share gains.

• acceleration of personalized, preventive, and home-based care models supported by advances in telemedicine, remote monitoring, and digital engagement;

• growing consumer demand for clinically validated and accessible genetic testing solutions that support early detection, therapy selection, and proactive disease prevention;

• increased focus on health equity and inclusion, driving access to genetic insights across ancestries and underserved populations, supported by payor and policy initiatives;

• broader use of large-scale data and analytics to enhance clinical interpretation, evidence generation, and biopharma collaboration opportunities;

• rapid adoption of low-cost sequencing and automation technologies that are enhancing scalability, reducing turnaround times, and enabling broader access to testing;

• integration of artificial intelligence (AI) across laboratory operations, prior authorization, image analysis, and data interpretation to enhance efficiency, speed, and accuracy;

• expansion of biomarker legislation across multiple U.S.

states, supporting payor adoption and clinical use of genetic and molecular diagnostic tests;

• growth in precision medicine and companion diagnostics partnerships between diagnostic companies, academic institutions, and biopharma, advancing targeted treatment approaches.

We believe these trends create opportunities to position Myriad for sustainable growth, market share expansion, and leadership across Oncology, Women's Health, and Mental Health.

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

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Since the implementation of this program in 2022, we have consistently maintained a strong NPS above 70, which we believe indicates a high level of user satisfaction and advocacy.

This serves as a valuable benchmark for our ongoing efforts to enhance and innovate our offerings to better meet the needs of our patients and clinicians.

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

and other commercial and academic laboratories.

As a leader in molecular diagnostic 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.

Whether it's therapy selection, early recurrence detection, or later in the patient journey, our products provide actionable, scientific insights to oncologists that can facilitate their treatment of patients.

This continues to serve as a key benchmark for our commitment to an excellent patient and provider experience.

In oncology, we offer testing for patients across their cancer journey, from identification of genes that increase cancer risk, to predicting whether they are candidates for targeted treatments.

Our competitors in the oncology market include Natera, Inc., Foundation Medicine, Inc., Caris Life Sciences, Tempus, Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Veracyte, Inc., Guardant Health, Inc., MDxHealth SA, NeoGenomics, Inc., and other commercial and academic laboratories.

Whether it is therapy selection, early recurrence detection, or later in the patient journey, our products provide actionable, scientific insights to oncologists that can facilitate their treatment of patients.

We believe that the key opportunities to grow our Oncology business include expanding our diagnostic offerings, adding indications and genes to existing oncology tests, reducing friction for providers with automated ordering and reporting, and increasing our focus and investment in clinical evidence generation.

In 2026, we plan to add a new liquid biopsy therapy selection test called Precise Liquid to our comprehensive Oncology offerings.

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 the test is expected to allow 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.

In 2026, we plan to continue to expand our Precise Oncology portfolio with new offerings, including Precise MRD, a high-definition, tumor-informed assay that uses whole genome sequencing to detect molecular residual disease and guide treatment decisions.

We are also investing in automation, digital workflows, and clinical evidence generation to support provider adoption and reimbursement, further strengthening our leadership in precision oncology.

Women’s Health

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We also offer the SneakPeek Early Gender DNA Test which predicts a baby's fetal sex 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 in women's health include Natera, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, BillionToOne, Inc., Tempus AI, Inc., and Peekaboo Early Detection Gender DNA Test.

Our competitors in women's health include Natera, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, BillionToOne, Inc., Tempus AI, Inc., Fulgent Genetics, Inc., 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 continue to drive growth in our Women's Health business by enhancing our prenatal products to improve patient access and deliver differentiated clinical utility, improving our cancer risk assessment programs with enhanced testing, ordering and reporting, and automating workflows to drive increased adoption of our breast cancer risk assessment program into large health systems and obstetrician and gynecologist practices.

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

We have expanded our SneakPeek product presence into retail stores, which we believe provides a strong opportunity for us to target consumers with our prenatal portfolio of offerings beyond reaching these patients directly through physicians.

We also plan to deliver improved and differentiated experiences for patients and physicians through an advanced, end-to-end digital architecture as we improve our test ordering and order management experience and digital tools for interacting with patients.

For example, Foresight Universal Plus, which launched in the second half of 2024, is an expanded carrier screening test that includes up to 272 genes.

We also 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 on a targeted 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 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 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.

We believe Foresight Universal Plus and FirstGene when launched, will strengthen our clinical differentiation in the growing carrier screening market, and provides us an opportunity to meet the increasing demand for advanced reproductive genetic testing in 2025 and beyond.

Pharmacogenomics

In Pharmacogenomics, we help physicians and other front-line providers understand how genetic alterations may impact patient response to antidepressants and other drugs.

We expect to further advance prenatal care with the launch of FirstGene, which began a limited-access rollout in 2025 and is expected to launch fully for commercial use in 2026.

FirstGene is a next-generation 4-in-1 prenatal screening solution combining Prequel NIPS (with AMPLIFY™ technology), Foresight carrier screening, fetal recessive status, and feto-maternal blood compatibility in a single maternal blood draw, designed to simplify workflow and improve sensitivity for all pregnancies.

We believe FirstGene will strengthen our clinical differentiation in the growing carrier screening market providing us with an opportunity to better meet the increased demand for advanced reproductive genetic testing.

Mental Health

In Mental Health, we help physicians and other front-line providers 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 has been shown to improve response rates in patients compared to standard of care.

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

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

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

We believe our highly effective digital engagement and provider on-boarding approach broadens 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.

We continue to work on expanding coverage, including through the increasing number of state biomarker laws, while also optimizing our patient direct-payment options and workflow to maximize reimbursement.

We have historically experienced seasonality in our testing business.

The quarters ending March 31 and September 30 are typically weaker due to the annual reset of patient deductibles in the beginning of each calendar year and vacation schedules in the summer.

The quarter ending December 31 is typically stronger due to increased demand as patients meet their deductibles throughout the year;

however, due to various factors, including disruptions in workflows arising from EMR integrations, volumes were less than expected for the quarter ended December 31, 2024.

Seasonal patterns were disrupted in previous years as a result of the COVID pandemic and certain other factors, but we believe pre-COVID seasonality impacted 2024, particularly in the third quarter.

Additionally, operating results for the twelve months ended December 31, 2024 may not necessarily be indicative of results to be expected for any year.

We continue to leverage our digital engagement and provider onboarding programs to expand adoption among primary care and behavioral health clinicians, who treat the majority of patients with depression and anxiety.

We are actively working on expanding coverage, including through the increasing number of state biomarker laws, while also optimizing our patient direct-payment options and workflow to maximize reimbursement.

The Company has historically experienced some seasonality in its business, including due to factors such as the timing of deductibles resetting or being met.

While the Company continues to experience periodic fluctuations in quarterly revenues, these variations are increasingly influenced by other factors such as the timing of customer activity, reimbursement dynamics, and broader market conditions.

Additionally, we believe operating results for the twelve months ended December 31, 2025 may not necessarily be indicative of results to be expected for any other year.

Human Capital Management

As a leader in molecular diagnostic 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.

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 and competitive compensation and benefits programs.

As of December 31, 2024, we have approximately 2,700 full-time equivalent employees.

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

We believe the success of our mission depends, in part, on our ability to attract, retain and motivate highly skilled and qualified personnel who share our values and commitment to innovation.

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

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

As of December 31, 2025, we had approximately 2,700 full-time equivalent employees.

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.

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

Myriad supports a culture of caring 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.

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

Our active ERG communities provide a safe space for teammates from shared backgrounds and their allies to connect, communicate and support each other.

These ERGs are designed to 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.

We foster a culture of caring 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.

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

Our active ERG communities provide a safe space for teammates from shared backgrounds and their allies to connect, learn together, communicate and support each other.

These ERGs are designed to mentor, develop, foster, encourage, and inspire employees in all stages of their careers by providing access to senior leadership, peer groups, mentoring, education, and other valuable resources to help employees achieve their career aspirations and strengthen inclusion company-wide.

As of December 31, 2025, approximately 65% of our employees were women, and women held 35% of Myriad leadership roles (vice president and above).

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

Our efforts to recruit and retain a diverse workforce were validated by recognitions from the 2025 Disability Equality Index as a Best Place to Work for Disability Inclusion, the Age-Friendly Institute as a 2025 Age-Friendly Employer, and Mitratech as a 2025 Top Diversity Employer.

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

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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.

We also provide an expansive and evolving 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, preventative health screening, community outreach programs, and wellness programs.

Career Development and Training :

We offer several career development and training opportunities to our employees, including a curriculum of Company-sponsored technical, business and leadership courses, on-the-job training and a support network to all new employees, and tuition reimbursement for approved external training and educational pursuits.

We also sponsor a training and mentoring program for high potential employees to assist them in leadership skills and career development.

Oversight and Management :

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.

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

The results are reviewed by our Board of Directors 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 believe our most recent survey in 2025 shows how these intentional efforts are making a difference as 84% of our employees rated us as a Great Place to Work ® .

Myriad was also identified as one of America's Best Employers in 2025 from Forbes.

Corporate Responsibility and Community :

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We believe that our corporate 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.

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

Our corporate responsibility programs align with a clearly defined set of strategic priorities including the following:

• Patient Assistance :

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As described further below, we continue to explore ways in which we can minimize our environmental impacts.

• Scholarship :

We provide financial support for academic scholarships and contribute to advancing education and training for women and minorities in medicine and science.

• Philanthropy :

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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.

As part of our broader climate action plan, we have established Scope 1, Scope 2, and Scope 3 greenhouse gas intensity reduction targets to guide our long-term efforts to reduce emissions across our operations.

Our Myriad Green Team engages employees across our business in environmental activities and events that benefit local communities.

We continue to recycle plastics used in our laboratory facilities.

Our new laboratories in west Salt Lake City, Utah and South San Francisco, California include energy and water efficiency and other environmental-friendly features.

The Nominating 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.

Our laboratories in West Salt Lake City, Utah and South San Francisco, California include energy and water efficiency and other environmental-friendly features.

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

In connection with our Quality, Innovation, and Corporate Responsibility Report, we disclosed our Scope 1 and Scope 2 emissions data.

Moving forward, we plan to improve our environmental footprint assessment and provide additional public disclosures regarding our environmental performance to our stockholders.

For more information on our approach to sustainability, please refer to our 2023-2024 Quality, Innovation, and Corporate Responsibility Report, which is available on our website.

Moving forward, we plan to improve our environmental footprint assessment and expect to provide expanded public disclosures, including additional greenhouse gas information and updates on progress when those materials become available.

Patents and Proprietary Rights

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These patents and applications contain multiple claims including but not limited to those claims described below.

Test Patent Assets Expiration Claims

Test Patent Assets Expiration Exemplary Claims

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

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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.

FirstGene Multiple Prenatal Screen

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

and other jurisdictions relating to FirstGene testing.

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

Claims relating to systems and methods for detecting genetic sequences, preparation of biological samples with enriched fetal fraction, and parallel detection of aneuploidy and genetic variants.

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

or other jurisdictions relating to MRD testing.

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

The table below lists important licenses to technology that is relevant to certain of our tests:

The table below lists important licenses to technologies that are relevant to certain of our tests:

Entity Subject Royalties Expiration

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Failure to comply with the applicable laws and regulations can subject us to repayment of amounts previously paid to us, significant civil and criminal penalties, loss of licensure, certification, or accreditation, or exclusion from state and federal health care programs.

The significant areas of regulation are summarized below.

The significant areas of regulation applicable to us are summarized below.

Clinical Laboratory Improvement Amendments of 1988 and State Regulation

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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, the FDA had exercised enforcement discretion for LDTs, meaning that the FDA generally did not enforce 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.

Following several years of inaction by Congress on this issue, the FDA issued a final rule in May 2024 to regulate LDTs under the current medical device framework and proposed to phase out the current enforcement discretion policy;

the final rule became effective on July 5, 2024.

The FDA LDT enforcement policy phase-out process will 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.

Moderate-risk and low-risks tests are expected to be in compliance at the 4-year mark, although FDA has stated that if premarket submissions are pending review it will continue to exercise enforcement discretion with respect to those tests.

The FDA’s final rule is complex and, concurrently, the agency announced several exceptions from the requirement to comply with full medical device regulatory controls, depending upon the specific nature of the LDT and the clinical laboratory that is offering such LDT for use by health care providers.

We have begun the process of implementing the final rule with respect to our tests, our operations, and our business more generally.

Publication of the LDT final rule prompted the American Clinical Laboratory Association (ACLA) and one of its members, on May 29, 2024, as well as the Association for Molecular Pathology (AMP) and one of its members, on August 19, 2024, to file complaints against the FDA in the Eastern District of Texas and the Southern District of Texas, respectively.

Both complaints allege that the agency does not have authority to promulgate the LDT final rule and seek to vacate the FDA’s action;

the two cases were subsequently consolidated into a single action pending in the Eastern District of Texas.

Briefing is ongoing in the consolidated case and the outcome is uncertain.

The ongoing litigation could potentially affect the FDA’s plans to implement these new LDT requirements, making the implementation timeline somewhat uncertain although no preliminary injunction has been issued to date.

Accordingly, the agency has continued its implementation efforts by actively providing guidance and training to clinical laboratories on how to comply with medical device general controls.

Following the November 2024 federal elections, it is unclear whether the incoming Trump Administration will continue to defend the FDA’s rulemaking action in the consolidated litigation in Texas or if it will take steps to rescind or modify the LDT final rule.

Affected stakeholders also 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 FDA's final rule, which may be disruptive to the industry and to patient access to certain diagnostic tests.

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.

However, this FDA rulemaking was initiated after years of failed congressional attempts to harmonize the regulatory paradigms applicable to LDTs and other IVDs, making it unclear whether any legislative efforts would be successful going forward.

The outcome of the November 2024 elections on the composition of the 2025-2026 Congress, with both the Senate and House transitions to Republican control, also creates uncertainties for the diagnostic industry.

Historically, the FDA has exercised enforcement discretion for LDTs, meaning that the FDA generally did not enforce premarket review and other applicable FDA requirements.

As LDTs increased in complexity over recent decades, the FDA took a risk-based approach to their regulation, while Congress also signaled interest in clarifying the regulatory landscape for LDTs as stakeholders across the spectrum expressed a need for regulatory certainty and clear operational guidelines.

However, following several years of inaction by Congress on this issue, the FDA issued a final rule in May 2024 to regulate LDTs under the existing medical device framework and to phase out its longstanding enforcement discretion policy;

the final rule became effective on July 5, 2024 and was expected to begin entering into force against non-exempt "LDT manufacturers" in May 2025.

Following issuance of the LDT final rule, the American Clinical Laboratory Association (ACLA) and one of its members, as well as the Association for Molecular Pathology (AMP) and one of its members, filed complaints against the FDA in the Eastern District of Texas and the Southern District of Texas, respectively.

Both complaints alleged that the agency did not have authority to promulgate the LDT final rule and sought to vacate the FDA’s action;

the two cases were subsequently consolidated into a single action.

On March 31, 2025, the U.S.

District Court for the Eastern District of Texas vacated the final rule in its entirety and remanded the matter to the FDA, holding that the rule exceeded the agency’s authority under the Federal Food, Drug, and Cosmetic Act.

The FDA did not appeal the decision.

As a result, the phase-in deadlines established by the rule are no longer operative, and in September 2025 the FDA implemented the court’s vacatur of the final rule with a formal public notice.

The court’s decision striking down the final rule preserves the existing enforcement-discretion policy for LDTs, which reduces the immediate regulatory burden for laboratories such as ours.

However, uncertainty remains regarding the future of federal oversight in this area, as Congress could enact new legislation establishing a statutory framework for regulating all IVDs, including LDTs.

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.

In Vitro Diagnostics as Medical Devices

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As an alternative to the De Novo classification process, the manufacturer could 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, and it recently issued a final rule to clarify the administrative process through which the agency reclassifies a medical device.

The FDA can also initiate reclassification of an existing device type on its own initiative, and it has previously issued a final rule 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 application.

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 regulatory 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 may affect our current or future products.

Premarket Approval

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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.

Recently, the FDA issued a proposed rule to reclassify certain nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product from Class III (PMA) into Class II, subject to premarket notification with special controls.

The proposal is based in part on the history of safe and effective use of our BRACAnalysis CDx and other oncology therapeutic nucleic acid-based test systems for their intended uses.

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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• 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.

The agency has issued a final rule called the Quality Management System Regulation (QMSR) to harmonize the FDA’s medical device current good manufacturing practice regulations with the International Organization for Standardization standard for device quality management systems (ISO 13485:2016).

The effective date for the QMSR final rule is February 2, 2026.

Until then, manufacturers are required to comply with the QSR.

In addition, device manufacturers are required to register their establishments and list their devices with the FDA and are subject to periodic inspections by the FDA and certain state agencies.

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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.

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

For certain IVDs, compliance with the essential requirements is subject to assessment by a Notified Body, a third-party organization designated by the relevant NCAs to assess regulatory 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 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.

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 EU 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, 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).

Among other things, the IVDR introduced a new risk-based classification for IVDs and classified 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 (QMS) before they can be placed on the market.

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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.

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

Due to multiple challenges to IVD manufacturers being ready for full application by the May 2022 implementation date, risk of shortages and limited Notified Body capacity, transition periods have been revised several times for legacy devices.

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Medical devices certified under the Directive may benefit from the extension provided they meet certain conditions ((i) continue to comply with the Directive, (ii) not be the subject of significant changes on design or intended purpose, (iii) not present an unacceptable health or safety risk, (iv) the manufacturer has in place a quality management system according to the IVDR rules before May 26, 2025, and (v) the manufacturer has applied to a Notified Body and has signed a written agreement for a conformity assessment under the IVDR rules by a certain date, depending on the risk class of the IVD).

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.

Certain IVDR requirements, including post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices became 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.

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 now a free-standing regulatory regime.

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.

The UK is currently developing new legislation 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.

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.

The withdrawal of the United Kingdom (UK) from the EU in 2021 meant that the EU IVDR did not take effect in Great Britain (England, Scotland, and Wales).

Instead, the UK continues to rely on the Medical Devices Regulations 2002 (UK MDR), which implemented the former EU Directives and have since been amended several times to reflect post-Brexit changes.

However, under the Northern Ireland Protocol, the IVDR does apply in Northern Ireland.

The competent authority for devices and IVDs in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), issued guidance on the regulation of IVDs in the UK following Brexit, and amendments were made to the UK MDR to take account of the fact that the UK now has a free-standing regulatory regime.

As currently described in these provisions, MHRA continues to recognize EU CE marks within Great Britain until July 2030 for certain devices, in order to align with EU transition periods.

It is anticipated, following a consultation response published by the UK government in August 2025, that EU CE marks will be recognized indefinitely in the UK.

IVD legal manufacturers wishing to place IVDs on the UK market are required to register with the MHRA and those based outside of the UK must appoint a UK Responsible Person to manage compliance efforts in the UK.

The UK government is currently reviewing the regime governing medical devices and IVDs in the UK with changes being made to the UK MDR slowly and incrementally to better align with international best practices, including some similarities to the IVDR.

For example, new regulations on medical device post-market surveillance requirements came into force in June 2025.

Additionally, following Brexit, a new marking called UK Conformity Assessed (UKCA) mark was introduced specifically for use in the UK.

In the consultation response mentioned above, the UK government confirmed that it intends to remove the requirement for a UKCA marking to be affixed to a medical device or IVD, or its sterile pack, in order for it to be placed on the GB market where the product has undergone conformity assessment in the UK (however, this will remain optional, addressing a concern that the change would lead to relabeling activities).

Instead, manufacturers will need to assign a Unique Device Identification (UDI) to their device and the UDI will need to be registered in a publicly accessible database.

The UK government has also recognized that the current classification of IVDs under the UK MDR is outdated.

As such, it intends to change the existing list-based classification of IVDs, derived from the EU Directive, to a risk-based framework.

This approach generally aligns with principles developed by the International Medical Device Regulators Forum (IMDRF) and with the classification of IVDs under the EU 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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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.

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 started discussion in May 2024 on the upcoming revision of the Pharmaceuticals and Medical Devices Act, such discussion includes a reform of sales system of medical products which may include IVDs as well as a review of performance evaluation based on the characteristics of IVDs (introduction of a system similar to the re-evaluation system for pharmaceuticals).

The first round of changes to Japan’s PMDA took effect in September 2020 and August 2021.

A further revision in May 2022 introduced a fast-track approval pathway for IVDs, allowing conditional or time-limited approval in emergency situations where the efficacy of medical product is presumed, subject to confirmation of safety.

The revision enacted in May 2025, while applicable to pharmaceuticals in general (including IVDs), establishes systems to secure the quality and safety of pharmaceuticals, ensure stable supply chains, foster an environment conducive to more active drug development, and strengthen the role of drug stores.

Revisions specific to IVDs include:

(i) the abolition of pre-approval testing prior to manufacture and sale;

(ii) introduction of a system similar to the pharmaceutical re-evaluation system;

and (iii) the creation of an exception under which the production manager for IVDs is not necessarily required to be a pharmacist.

These revisions will take effect within six months to two years, depending on the relevant provision.

Additional International Regulation

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In many countries outside of the United States, coverage, pricing and reimbursement approvals are also required.

We are also required to maintain accurate information on and control over sales and distributors’ activities that may fall within the purview of the Foreign Corrupt Practices Act, its books and records provisions and its anti-bribery provisions, as well the UK Bribery Act and other anti-corruption laws.

HIPAA and Other Privacy Laws

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Other federal and state laws establish additional requirements for protecting the privacy and security of health information that is not protected by HIPAA.

For instance, Washington state recently passed the “My Health My Data” Act, which will regulate “consumer health data,” which is defined as “personal information that is linked or reasonably linkable to a consumer and that identifies a consumer’s past, present, or future physical or mental health.” The “My Health My Data” Act provides exemptions for personal data used or shared in connection with certain research activities, including data subject to 45 C.F.R.

For instance, Washington state passed the “My Health My Data” Act, which will regulate “consumer health data,” which is defined as “personal information that is linked or reasonably linkable to a consumer and that identifies a consumer’s past, present, or future physical or mental health.” The “My Health My Data” Act provides exemptions for personal data used or shared in connection with certain research activities, including data subject to 45 C.F.R.

Parts 46, 50 and 56.

Notably, the “My Health My Data” Act contains a private right of action.

In addition, Nevada recently enacted a consumer health data privacy bill, SB 370, which also regulates “consumer health data” and shares many similarities with Washington’s “My Health My Data” Act, and Connecticut recently amended its comprehensive privacy law to include heightened regulation of “consumer health data.” Additional states may adopt health-specific privacy laws that could impact our business activities and our collection and handling of health-related data.

In addition, Nevada enacted a consumer health data privacy bill, SB 370, which also regulates “consumer health data” and shares many similarities with Washington’s “My Health My Data” Act, Connecticut amended its comprehensive privacy law to include heightened regulation of “consumer health data,” and Texas amended its comprehensive privacy law to include heightened regulation of biometric and genetic data.

Additional states may adopt health-specific privacy laws that could impact our business activities and our collection and handling of health-related data.

In addition to the federal privacy and security regulations and health privacy law referenced above, 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 Factors" section below.

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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.

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

Several states have enacted legislation requiring medical device manufacturers to, among other things, establish marketing compliance programs, file periodic reports with the state, and make periodic public disclosures on sales and marketing activities, and such laws may also prohibit or limit certain other sales and marketing practices.

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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 Continuing Appropriations and Extensions Act, 2025 (Pub.L.

118-83, enacted on September 26, 2024) 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, 2026 through March 31, 2026, and will be based on the original 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.

Most recently, on February 3, 2026, Section 6226 of the Continuing Appropriations Act, 2026 further delayed the data reporting requirements for CDLTs that are not ADLTs as well as the phase-in of payment reductions.

The next data reporting period will be from May 1, 2026 through July 31, 2026, and will be based on an updated data collection period of January 1, 2025 through June 30, 2025.

A 0% payment reduction will be applied until January 30, 2027, so that the fee schedule amount for a CDLT that is not an ADLT may not be reduced compared to the payment amount for that test in CY 2026.

From January 31, 2027 through December 31, 2028, payment may not be reduced by more than 15% percent per year compared to the payment amount established for a test the preceding year.

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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The same series of laws discussed above 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 2024.

The Further Continuing Appropriations and Extensions Act, 2025 further applied a 0.0 percent reduction limit for calendar year 2025.

Consequently, payment may not be reduced by more than 15 percent per year for calendar years 2026 through 2028 as compared to the payment amount established for a test the prior year.

Consequently, payment may not be reduced by more than 15 percent per year from January 31, 2027 through December 31, 2028 as compared to the payment amount established for a test the prior year.

Given the many uncertainties built into PAMA’s price-setting process, we cannot predict how payments we receive under the CLFS, and thus our revenue, may change from year to year.

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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