Myriad Genetics Stock

Myriad Genetics, Inc. (Myriad) operates as a genetic testing and precision medicine company.

The company develops and offers tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower health care costs. The company's genetic 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 the company has specialized products, capabilities, and expertise: Oncology, Women's Health, and Pharmacogenomics. The pillars of the company's long-term growth strategy are founded on investments in science and innovation, technology-enabled operations, an elevated customer experience, strong commercial execution, and scalable operations. The company's path to continued growth is driven by articulating the company's clinical differentiation, raising awareness with patients who would benefit from the company's testing products, and innovation that improves clinical outcomes, ease of use, and access.

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 three key areas where the company has specialized products, capabilities, and expertise:

Oncology: 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 for women of all ancestries, assessing cancer risk, and offering prenatal testing solutions.

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

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 one or more of these cancers. 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. 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 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 have received approvals from the FDA in ovarian cancer, metastatic breast cancer, pancreatic cancer, and advanced prostate cancer. The test is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid (EDTA).

MyChoice CDx Companion Diagnostic Test: 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 (GIS) encompassing loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions across the entire genome. The combination of these methods is a more comprehensive way to measure HRD status, versus either one alone.

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

Precise Tumor Molecular Profile Test: A tumor profile test offered as part of Precise Oncology Solutions, a comprehensive solution for advanced precision oncology. Precise Oncology Solutions combines the company's leading germline hereditary cancer tests (MyRisk/BRACAnalysis CDx), the company's HRD companion diagnostic test (MyChoice CDx), and a comprehensive genetic tumor panel. Precise Oncology Solutions will help providers determine a clear, integrated, and personalized treatment plan for patients with cancer.

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

Foresight Carrier Screen: a prenatal test for future parents to assess their risk of passing on a recessive genetic condition to their offspring. The Foresight test screens for carrier status of up to 176 genes associated with serious and prevalent inherited conditions. The test has been shown to have a detection rate of 99% across all ethnicities. 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 single, Y chromosome marker in the maternal blood sample. If Y chromosome markers are found in the mother's blood, the baby is male. If no Y chromosome markers are detected, the baby is female.

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 sells its tests primarily through its own sales force and marketing efforts in the United States, Japan, Germany, and France, and the company service additional global accounts through indirect sales channels. The company's U.S. sales force is consisted of approximately 500 individuals across the company's dedicated sales channels. The company continues to optimize its sales and marketing channels through increased digital marketing, direct to patient marketing, enhanced virtual sales tools, and inside sales teams to drive efficiency in the company's sales model. For example, in 2023, the company formalized a national account focus in the company's Oncology and Women's Health products to address the needs of the company's largest accounts who are dealing with population health and value-based care decisions, while the company's field sales teams remained focused on core customers across channels. The company continues to expand and strengthen its inside sales team with improved segmentation and territory alignment and by expanding the company's inside sales team to cover additional products. The company's inside sales team focuses on a broader base of qualified leads, freeing up the field sales team to target higher potential clinical leads.

Seasonality

The company has historically experienced seasonality in its testing business. In the quarter ended March 31, the company typically experiences a decrease in volumes due to the annual reset of patient deductibles. Additionally, the volume of testing is typically negatively impacted by the summer season, which is generally reflected in the quarter ended September 30. Conversely, the quarter ended December 31 is generally strong as the company typically experiences an increase in volumes from patients who have met their annual insurance deductible.

Competition

Oncology

The company's competitors in the oncology market include Invitae Corporation, Ambry Genetics Corporation, Natera, Inc., Foundation Medicine, Inc, Caris Life Sciences, Tempus, Laboratory Corporation of America Holdings, and Quest Diagnostics Incorporated.

Women's Health

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

Pharmacogenomics

The company's competitors include Genomind, Tempus, Quest Diagnostics Incorporated, and Laboratory Corporation of America Holdings.

Trademarks

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, ColarisAP, 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, GeneSight, and EndoPredict are registered trademarks or trademarks of Myriad.

Research and Development

For the year ended December 31, 2023, the company incurred research and development expense of $88.7 million.

Governmental Regulation

The company's laboratories in Salt Lake City, Utah, Mason, Ohio, and South San Francisco, California are CLIA (the Clinical Laboratory Improvement Amendments of 1988) 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 (the Centers for Medicare & Medicaid Services)-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 maintain an active compliance program that is designed to meet requirements of the privacy and security rules and to identify privacy and security incidents and other issues in a timely fashion so that the company may remediate, mitigate harm and report if required by law.

In addition, the company's advertising for laboratory services using FDA-cleared or approved IVDs, as well as services using LDTs that are not FDA-approved is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (FTC), as well as certain state laws.

History

Myriad Genetics, Inc. was founded in 1991. The company was incorporated in the state of Delaware in 1992.