Myriad Genetics, Inc.

https://www.myriad.com

Myriad Genetics, Inc. is an American genetic testing and precision medicine company headquartered in Salt Lake City, Utah, United States. The company's core mission is to advance health and well-being by empowering individuals and healthcare providers with genetic insights to better detect, treat, and prevent disease.

Myriad Genetics develops and commercializes a comprehensive portfolio of molecular diagnostic tests across various medical specialties. Key product areas include hereditary cancer risk assessment (e.g., MyRisk Hereditary Cancer, BRACAnalysis), tumor profiling (e.g., MyChoice CDx, Prolaris for prostate cancer), prenatal screening (e.g., Foresight, Prequel), and pharmacogenomics (e.g., GeneSight for mental health medications). These tests are designed to assess an individual's risk for developing disease, predict disease progression, guide treatment decisions, and identify a patient's likelihood of responding to specific drug therapies.

Under the leadership of President and CEO Sam Raha, Myriad Genetics is strategically focused on its Cancer Care Continuum to drive accelerated growth, expanding its test portfolio into areas such as therapy selection and Molecular Residual Disease (MRD) testing. The company reported full-year 2025 revenue of $824.5 million and has projected revenues between $860 million and $880 million for 2026, with plans for new product launches in 2026, including an AI-enabled Prolaris test and Precise MRD.

Latest updates

Myriad Genetics Data Highlights MRD Test Performance in Breast Cancer Trials

Event summary

  • Myriad Genetics will present six abstracts, including two podium presentations, at the American Association for Cancer Research (AACR) Annual Meeting 2026, April 17-22.
  • Data from the MONITOR-Breast study will be presented, focusing on ctDNA dynamics during neoadjuvant therapy using Myriad’s Precise MRD assay.
  • The study, involving multiple centers, includes a large cohort of patients receiving neoadjuvant therapy and provides high-temporal resolution characterization of ctDNA dynamics.
  • A phase II clinical trial results will also be presented by Dr. Ranjan Upadhyay from The University of Texas MD Anderson Cancer Center.

The big picture

Myriad's presentation at AACR underscores the growing importance of liquid biopsies and ctDNA analysis in cancer treatment, particularly in breast cancer where treatment paradigms are rapidly evolving. The MONITOR-Breast study’s longitudinal data provides a significant advantage, but the company faces increasing competition in the rapidly expanding precision oncology diagnostics market. Success hinges on demonstrating clinical utility and securing broader adoption within oncology workflows.

What we're watching

Clinical Adoption
The extent to which the MONITOR-Breast data influences oncologist adoption of Precise MRD in standard treatment protocols will be a key indicator of commercial success.
Competitive Landscape
How competitors respond to Myriad's data and refine their own liquid biopsy offerings will determine the long-term market share dynamics in MRD testing.
Regulatory Pathway
The pace at which regulatory bodies evaluate and potentially expand indications for Precise MRD, particularly given its role in personalized treatment decisions, will impact revenue growth.

Myriad Data Suggests ctDNA Testing Could Refine Ovarian Cancer Recurrence Prediction

Event summary

  • Myriad Genetics presented four abstracts at the SGO Annual Meeting, April 10-13, 2026, in San Juan, Puerto Rico.
  • Data from Myriad’s Precise MRD™ test showed a significant correlation between ctDNA fraction and ovarian cancer recurrence.
  • The Myriad Collaborative Research Registry (MCRR) contains de-identified data from over 1.3 million participants.
  • Studies using the MCRR explored genetic variant prevalence in endometrial and ovarian cancers, and the utility of universal hereditary cancer screening.
  • Presentations included findings on Lynch syndrome gene association with ovarian cancer diagnosis and age at diagnosis.

The big picture

Myriad’s focus on MRD testing and leveraging its large patient registry underscores a broader trend in oncology towards personalized medicine and earlier detection of recurrence. The company’s ability to translate these research findings into commercially viable tests and secure reimbursement will be critical for sustained growth. The MCRR represents a significant asset, but its value is contingent on maintaining its scale and relevance within the evolving research landscape.

What we're watching

Clinical Adoption
The uptake of Precise MRD testing by oncologists will depend on reimbursement policies and demonstrated clinical utility beyond the presented data, potentially impacting Myriad’s revenue projections.
Data Integrity
The value of the MCRR is predicated on maintaining data quality and participant privacy, and any breaches or methodological concerns could erode trust and limit its research utility.
Competitive Landscape
Other diagnostic companies are developing similar ctDNA-based recurrence monitoring tests, and Myriad’s market share will be influenced by the performance and pricing of competing offerings.

Myriad Gains Exclusive Ovarian Cancer Test Niche with FDA Approval

Event summary

  • Myriad Genetics received FDA approval for its MyChoice CDx Test as a companion diagnostic for GSK’s Zejula (niraparib) for advanced ovarian cancer.
  • The approval is based on data from the PRIMA trial, which used the MyChoice CDx Test to stratify patients based on homologous recombination deficiency (HRD) status.
  • The MyChoice CDx Test is the only FDA-approved companion diagnostic in the U.S. to identify HRD-positive patients eligible for Zejula treatment.
  • Approximately 50% of patients with advanced ovarian cancer have HRD-positive tumors, representing a significant potential patient population.

The big picture

This approval establishes Myriad as a key player in the rapidly expanding precision oncology diagnostics market, capitalizing on the growing trend towards personalized cancer treatment. The exclusivity granted by the FDA approval provides a valuable competitive advantage, but the long-term success hinges on demonstrating clinical utility and securing favorable reimbursement. The PARP inhibitor market, while promising, is also facing increasing scrutiny regarding efficacy and patient selection, which could impact the demand for companion diagnostics.

What we're watching

Market Adoption
The speed of adoption by oncologists and hospitals will determine the initial revenue impact, as broader use requires education and integration into treatment protocols.
Competitive Landscape
While currently exclusive, the emergence of competing HRD tests could erode Myriad’s market share, particularly if they offer a more cost-effective or comprehensive analysis.
Reimbursement
Securing favorable reimbursement rates from payers will be critical for sustained growth, and any challenges in this area could limit patient access and test utilization.

Myriad Launches ctDNA Test, Eyes Broader Oncology Market

Event summary

  • Myriad Genetics launched Precise MRD, a tumor-informed circulating tumor DNA (ctDNA) assay, with a limited release to select community oncologists.
  • The test uses whole-genome sequencing to detect ctDNA at a sensitivity of one part per million.
  • Initial availability is focused on breast cancer patients, with a broader U.S. commercial launch planned for later in 2026.
  • The test provides longitudinal monitoring during cancer treatment, aiding in treatment decisions and detecting recurrence.

The big picture

Myriad's Precise MRD launch represents a strategic shift towards higher-margin, personalized diagnostics within the oncology space. The test addresses a growing demand for earlier cancer detection and treatment monitoring, driven by advancements in ctDNA technology and a desire to reduce reliance on traditional imaging. However, the limited initial release and dependence on reimbursement raise questions about the test’s long-term commercial viability and Myriad’s ability to compete in a rapidly evolving market.

What we're watching

Market Adoption
The success of Precise MRD hinges on adoption rates among community oncologists, which will be influenced by reimbursement policies and clinical validation data beyond the initial release.
Competitive Landscape
While Myriad emphasizes precision, other diagnostics companies are also developing ctDNA assays; the test’s differentiation and pricing will be critical for sustained market share.
Expansion Scope
Myriad’s stated plan to expand Precise MRD to other cancer types will determine the overall revenue potential and require significant investment in assay development and clinical trials.

Myriad Data at ASCO-GU Bolsters MRD, Prognostic Test Claims

Event summary

  • Myriad Genetics presented six abstracts at the ASCO-GU 2026 conference, focusing on its Precise MRD, Prolaris, and MyRisk tests.
  • Data from a meta-analysis of 14 studies (over 8,000 patients) supports the prognostic power of the Prolaris prostate cancer test, showing significance beyond clinical risk factors.
  • MyRisk testing data suggest germline variant prevalence is consistent across Gleason score and NCCN risk groups, potentially broadening testing scope.
  • Precise MRD demonstrated high sensitivity in detecting ctDNA at concentrations below 100 parts per million in genitourinary cancers.
  • Presentations occurred February 26-28, 2026, at the Moscone West Conference Center in San Francisco.

The big picture

Myriad's presentation underscores the growing importance of molecular diagnostics in cancer treatment, particularly the shift towards earlier detection and personalized therapies. The data reinforces Myriad’s strategy of expanding its portfolio across the cancer care continuum, but also highlights the challenges of demonstrating clinical utility and securing reimbursement for these advanced tests. The company's ability to translate these findings into commercially viable products will be crucial for sustained growth.

What we're watching

Clinical Adoption
The pace at which clinicians integrate Precise MRD into standard treatment protocols will determine its revenue impact, particularly given the early-stage nature of the data presented.
Regulatory Scrutiny
Expanded MyRisk testing, as suggested by the data, could draw increased scrutiny from payers and regulators regarding cost-effectiveness and clinical utility.
Competitive Landscape
How competitors respond to Myriad’s MRD data and refine their own offerings will shape the long-term viability of Myriad’s position in the evolving molecular diagnostics market.

Myriad Genetics Revenue Stalls as New Tests Loom

Event summary

  • Myriad Genetics reported fourth-quarter 2025 revenue of $209.8 million, flat year-over-year, with a 4% increase excluding an $8.1 million headwind.
  • Full-year 2025 revenue decreased 2% year-over-year to $824.5 million, a 2% increase when excluding headwinds.
  • Key growth drivers included Prolaris (12%), hereditary cancer testing (9%), and GeneSight (9%) test volume.
  • The company expects Q1’26 revenue to be between $200 and $203 million, a 2% to 4% growth over Q1’25.

The big picture

Myriad Genetics' revenue stagnation highlights the challenges facing diagnostic companies reliant on established tests, particularly as reimbursement pressures mount. The company's pivot towards new, AI-powered offerings and MRD testing represents a strategic attempt to reignite growth, but the execution risk is significant given the company's recent struggles and the competitive landscape. The company's ability to successfully commercialize these new tests will determine its long-term viability.

What we're watching

Execution Risk
The success of Myriad's 2026 test launches (Precise MRD, AI-enabled Prolaris, FirstGene) will be critical to reversing the revenue decline, and the company's ability to integrate these new offerings effectively remains to be seen.
GeneSight Dependence
GeneSight's continued revenue contribution will be heavily influenced by payer coverage decisions, and the company must diversify its revenue streams to mitigate future coverage-related headwinds.
Market Dynamics
The pace at which adoption of Precise MRD and other new tests occurs will depend on physician acceptance and reimbursement rates, which are subject to evolving market dynamics and competitive pressures.

Myriad's FirstGene Validation Bolsters Prenatal Screening Play

Event summary

  • Myriad Genetics published a study in Clinical Chemistry validating its FirstGene® Multiple Prenatal Screen, using nearly 500 samples.
  • The study demonstrated ≥98.2% analytical sensitivity and ≥99.0% analytical specificity across all components of the test, including aneuploidy, recessive condition screening, and fetomaternal blood compatibility.
  • FirstGene utilizes fetal-fraction amplification and a novel trajectory analysis algorithm to enhance genotype resolution.
  • The test is currently being evaluated in the CONNECTOR study to assess real-world clinical performance and support clinical validity and utility.

The big picture

Myriad's FirstGene aims to consolidate multiple prenatal screening tests into a single assay, addressing a noted inefficiency in current US practices where less than half of pregnancies receive recommended screening for each modality. The high analytical sensitivity and specificity reported in this validation study are crucial for building clinician confidence and driving adoption, but the success of FirstGene hinges on demonstrating clinical utility and securing favorable reimbursement. The company's strategy of leveraging fetal-fraction amplification, similar to its Prequel test, suggests a broader platform approach to prenatal diagnostics.

What we're watching

Clinical Adoption
The CONNECTOR study's results will be critical; slow adoption could indicate underlying clinician hesitancy or competitive pressures impacting FirstGene's commercial prospects.
Reimbursement
Given the test's comprehensive nature and potential cost, securing favorable reimbursement rates will be essential for broad market access and profitability.
Competitive Landscape
The prenatal screening market is evolving rapidly; Myriad must demonstrate FirstGene’s sustained differentiation and value proposition against emerging competitors and alternative testing approaches.

Myriad Accelerates MRD Assay Launch, Data Bolsters Clinical Utility

Event summary

  • Myriad Genetics plans to launch its Precise MRD assay in March 2026, initially targeting breast cancer clinicians, followed by colorectal and renal cancers later in 2026.
  • Interim study data (MONITOR-Breast and MONSTAR-SCREEN-3) demonstrate high baseline sensitivity (93% in breast cancer, 100% in colorectal cancer) and predictive capabilities for recurrence and treatment response.
  • Precise MRD utilizes whole-genome sequencing to detect ctDNA down to one part per million (ppm), a significant improvement over first-generation assays.
  • The company has presented its MRD strategy at industry forums including ASCO Gastrointestinal Cancers Symposium and the J.P. Morgan Healthcare Conference.
  • MONSTAR-SCREEN-3 showed a one-month post-surgery recurrence prediction sensitivity of 100%.

The big picture

Myriad's accelerated launch of Precise MRD aligns with the growing trend towards personalized oncology and the increasing adoption of liquid biopsies for cancer monitoring. The assay's ability to detect ctDNA at extremely low levels positions Myriad to capitalize on the demand for more precise and earlier cancer detection, but success hinges on demonstrating clinical utility and securing reimbursement. The company's reliance on observational studies for validation also introduces a degree of uncertainty regarding real-world effectiveness.

What we're watching

Adoption Rate
The initial uptake by community-based clinicians in March 2026 will be a key indicator of Precise MRD’s commercial viability and Myriad’s ability to penetrate the market.
Clinical Validation
Continued validation of Precise MRD’s predictive power across a broader range of cancer types and patient populations will be crucial for expanding its clinical utility and reimbursement coverage.
Competitive Landscape
The emergence of competing ultrasensitive MRD assays and the potential for consolidation within the molecular diagnostics space could impact Myriad’s market share and pricing power.

Myriad Genetics Signals Growth, Margin Expansion in 2026 Guidance

Event summary

  • Myriad Genetics released preliminary Q4 2025 revenue of $207–$209 million and full-year revenue of $822–$824 million.
  • The company projects full-year 2026 revenue between $860 million and $880 million, a ~6% increase year-over-year.
  • Myriad anticipates adjusted EBITDA growth of approximately 43% to a range of $37–$49 million in 2026.
  • The company is providing 2026 financial guidance without GAAP reconciliation due to the difficulty in predicting adjusting items.

The big picture

Myriad Genetics' preliminary results and 2026 guidance suggest a renewed focus on growth and margin expansion following a period of strategic realignment. The company's reliance on non-GAAP metrics for guidance highlights the complexity of forecasting its performance, particularly given the sensitivity to factors like litigation charges and acquisitions. This signals a need for investors to scrutinize the underlying drivers of these projections and assess the sustainability of the anticipated improvements.

What we're watching

Execution Risk
The company's ability to achieve its ambitious 2026 revenue and EBITDA targets will depend on successful product launches and efficient operational execution, particularly given the lack of GAAP reconciliation for guidance.
Margin Sustainability
Whether Myriad can sustain the projected adjusted gross margin of 68–69% will hinge on managing costs associated with new product launches and navigating potential pricing pressures within the diagnostics market.
Regulatory Landscape
Changes in reimbursement policies from governmental or private insurers could significantly impact Myriad's revenue projections and necessitate adjustments to its commercial strategy.
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