Myriad Genetics, Inc. operates as a molecular diagnostic testing and precision medicine company.
The company develops and offers 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. The company’s molecular tests provide insights that help people take control of their health, and enable healthcare providers to be...
Myriad Genetics, Inc. operates as a molecular diagnostic testing and precision medicine company.
The company develops and offers 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. The company’s molecular tests provide insights that help people take control of their health, and enable healthcare providers to better detect, treat, and prevent disease.
Business Strategy
The company’s focus is on innovation and growth in three key areas where it has specialized products, capabilities, and expertise: Oncology, Women’s Health, and Pharmacogenomics. The company’s 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, the company plans to accelerate electronic medical records (EMR) integrations, expand its sales channels, including into large health systems, cross-sell its portfolio of testing products to providers, enhance its testing products within medical guidelines, demonstrate its clinical differentiation and value compared to the standard of care, and optimize its revenue cycle processes. The company also continues to invest in clinical evidence development to support the growth of its existing products, and the launch of new products, such as FirstGene, Precise Liquid, and Precise molecular residual disease (MRD), which it expects will help continue its growth. The company intends to continue to develop and enhance its 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.
Testing
The company’s 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. The company focuses its efforts in the following key areas where it has specialized products, capabilities, and expertise:
Oncology: Clarifying cancer risk and cancer treatment with genetic 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: Leveraging pharmacogenomics to help clinicians understand how genetics may impact patient metabolism and response to antidepressants, and other mental health medications.
Descriptions of the company’s tests are as follows:
MyRisk Hereditary Cancer Test: DNA sequencing test for assessing the risks for hereditary cancers. The company’s 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 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 the 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.
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 the company’s BRACAnalysis CDx test are used as an aid to identify patients who are eligible for treatment with the U.S. Food and Drug Administration (FDA) approved poly-ADP ribose polymerase (PARP) inhibitors. The company is the only laboratory with an FDA-approved test for this indication, and has received approvals from the FDA in ovarian cancer, metastatic breast cancer, pancreatic cancer, and advanced prostate cancer. The test is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA).
MyChoice CDx Companion Diagnostic Test: 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. 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.
Prolaris Prostate Cancer Prognostic Test: RNA expression tumor analysis for assessing the aggressiveness of prostate cancer. The company’s 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.
EndoPredict Breast Cancer Prognostic Test: RNA expression test for assessing the aggressiveness of breast cancer. 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 has been shown to accurately predict the 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.
Precise Tumor Molecular Profile Test: a comprehensive genomic profiling test. Precise Tumor is a pan-cancer, NGS-based assay that uses state-of-the-art, next-generation sequencing to discover and target important variants within tumors. 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.
Prequel Prenatal Screen: a non-invasive prenatal screening (NIPS) test conducted using maternal blood to screen for severe chromosomal disorders in a fetus. The Prequel test uses whole genome sequencing to assess for trisomies and monosomies in all 23 chromosomal pairs, including the sex chromosomes, along with microdeletions associated with common genetic diseases. Prequel has a low test failure rate at less than 1 in 1,000 patients, and has been validated in multiple clinical studies to be highly accurate. 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 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. Enabled by its AMPLIFY technology, Prequel is the first prenatal cell-free DNA (cfDNA) screen available at eight weeks gestational age.
Foresight Carrier Screen: a prenatal test for future parents to assess their risk of passing on a recessive genetic condition to their offspring. The expanded Foresight test screens for carrier status of up to 272 genes associated with serious and prevalent inherited conditions. The company’s expanded Foresight screening test aligns with the American College of Medical Genetics and Genomics (ACMG) guidelines, which recommend offering expanded carrier screening to individuals who are pregnant or considering pregnancy. 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 of gestation with 99% accuracy. Innovative cell-free DNA technology and precise algorithms in the SneakPeek test are used to screen for a 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.
GeneSight Psychotropic Mental Health Medication Test: DNA genotyping test to aid psychotropic drug selection for patients suffering from depression, anxiety, attention-deficit/hyperactivity disorder (ADHD), and other mental health conditions. The GeneSight test provides healthcare professionals with information about which medications may require dose adjustments, may be less likely to work for a patient, or may have an increased risk of side effects based on a patient's genetic makeup. GeneSight covers 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 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. 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 the standard of care.
Sales and Marketing
The company primarily sells its tests through its sales force and marketing efforts in the United States and Japan, while servicing additional global accounts via indirect sales channels. The company’s U.S. sales force consists of approximately 500 individuals across its dedicated sales channels. The company continuously optimizes its sales and marketing channels by increasing digital marketing, leveraging direct-to-patient marketing, enhancing virtual sales tools to drive efficiency, and utilizing its inside sales team.
To create a seamless experience for providers and patients, the company is expanding its footprint in EMRs across hospital systems and other providers. This allows the company to offer the ordering and reporting functionality that providers need in their clinical practice. Additionally, this investment allows the company to better cross-sell its portfolio of products, providing a comprehensive set of tests for providers to use with their patients. Foundational to that effort includes improving the company’s products within medical guidelines to deliver value compared to the standard of care. The company also focuses on engaging with patients directly in establishing their family health history, assessing their eligibility for its products, and interpreting their test results. In the long term, the company is committed to building an end-to-end digital architecture to meet the needs of patients and providers, which will drive volume growth.
Research and Development
For the year ended December 31, 2024, the company incurred research and development expenses of $113.4 million.
Competition
Oncology
The company’s competitors in the oncology market include Natera, Inc., Foundation Medicine, Inc., Caris Life Sciences, Tempus, Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, and Veracyte, Inc.
Women’s Health
The company’s 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.
Pharmacogenomics
The company’s competitors in this market include Genomind, Tempus, Quest Diagnostics Incorporated, and Laboratory Corporation of America Holdings.
Seasonality
The company has historically experienced seasonality in its 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 (year ended December 31, 2024); 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.
Patents and Proprietary Rights
Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, MyRisk, Myriad myRisk, MyRisk Hereditary Cancer, MyChoice, Tumor BRACAnalysis CDx, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Foresight Universal Plus, Precise Tumor, Precise Oncology Solutions, Precise Liquid, Precise MRD, FirstGene, SneakPeek, SneakPeek Early Gender DNA Test, SneakPeek Snap, Urosuite, MyGeneHistory, Health.Illuminated., RiskScore, Prolaris, and GeneSight are registered trademarks or trademarks of Myriad.
Governmental Regulation
The company’s laboratories in Salt Lake City, Utah, Mason, Ohio, and South San Francisco, California are CLIA certified to perform high complexity tests.
Because the company’s 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.
The company is developing companion diagnostic tests for use with drug products in development by pharmaceutical companies, such as the company’s collaborations with pharmaceutical companies on PARP inhibitors for the treatment of ovarian, breast, and other cancers.
The company is 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.
Any products sold by the company pursuant to FDA clearances or approvals will be subject to pervasive and continuing regulation by the FDA. In particular, after a medical device is placed on the market, applicable regulatory requirements include:
Compliance with the FDA’s Quality System Regulation (QSR), which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;
Labeling and advertising regulations, which prohibit the promotion of FDA-regulated medical products for uncleared, or unapproved uses, or ‘off-label’ uses, and impose other restrictions on labeling; and
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 company is subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations, and maintains 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 it may remediate, mitigate harm, and report if required by law.
In addition, the company’s advertising for laboratory tests using FDA-cleared or approved IVDs, as well as 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.
History
Myriad Genetics, Inc. was founded in 1991. The company was incorporated in the state of Delaware in 1992.
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