Myriad Genetics Announces Precise MRD Clinical Data Published in The Lancet Oncology

By: Myriad Genetics, Inc. via GlobeNewswire

September 04, 2025 at 19:00 PM EDT

SALT LAKE CITY, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced The Lancet Oncology published a study highlighting the performance of Myriad’s molecular residual disease (MRD) test, Precise^® MRD, in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC).

One of the goals of this study was to determine whether patients with oligometastatic ccRCC could benefit from incorporating ultrasensitive MRD testing into their care. The study demonstrated that circulating tumor DNA (ctDNA) levels were associated with patients’ response to metastasis-directed radiation therapy (MDT). Precise MRD was able to detect ctDNA levels in patients with very low tumor burden. This may allow patients who are candidates for metastasis-directed radiotherapy without systemic therapy (MRWS) to delay or avoid systemic treatments, sparing patients from serious side effects and supporting treatment de-escalation.

Key MRD findings from this Phase 2 trial include:

94% of patients tested at baseline had ctDNA levels below 100 ppm, which falls in the ultrasensitive testing range.
Those who tested positive with Precise MRD prior to MRWS progressed to systemic therapy within a median time of 27 months, whereas those who tested negative were maintained on MDT for a median time of 54 months.
In those who were ctDNA negative and maintained on MDT, overall survival was not compromised, with survival rates of 94% at two years and 87% at three years.

“Our study demonstrated that MDT successfully delayed the initiation of systemic therapy in patients with oligometastatic ccRCC,” said Chad Tang, MD, associate professor in the department of genitourinary radiation oncology at The University of Texas MD Anderson Cancer Center (MDACC), and principal investigator of the study. “Median systemic therapy-free survival was nearly double in those who were ctDNA negative compared to those who were ctDNA positive, suggesting that ctDNA may be a promising biomarker to identify those who will benefit most from MDT.”

“Renal cancer is known to have low tumor fraction, making detection of ctDNA difficult for first-generation MRD assays,” said Dale Muzzey, PhD, chief scientific officer, Myriad Genetics. “Using the ultrasensitive Precise MRD Test, we could detect a wide range of ctDNA levels – from very high to very low – that were associated with response to metastasis-driven therapy. We are excited to continue characterizing the performance of Precise MRD in renal cancer, where biomarkers are urgently needed to inform care. The performance of Precise MRD in this challenging clinical setting is an encouraging indicator of its sensitivity in a range of other indications, such as breast cancer.”

About the Study
The study, “Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA) as a personalized biomarker,” was first shared at the 2025 American Association for Cancer Research Annual Meeting. The study was an investigator initiated single-arm trial enrolling patients with ccRCC and up to 5 metastases (NCT03575611). This study is among the largest trials conducted to date in this setting and includes one of the longest follow-up periods evaluating sequential metastasis directed therapy without systemic therapy for ccRCC. The Precise MRD Test was used to evaluate ctDNA levels as part of an exploratory endpoint to determine the association of translational biomarkers with patient outcomes.

About Myriad’s Precise MRD Test
Myriad’s Precise MRD Test is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants, enabling exceptional sensitivity and quantification of ctDNA in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment.

About Myriad Oncology™
Myriad Oncology provides a portfolio of advanced genetic and tumor genomic testing solutions, including risk assessment, screening, tools to aid treatment guidance, and survivorship. The Myriad Oncology offering is designed to meet the unique needs of oncology specialists and their patients across each step in the patient care continuum.

About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics 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 healthcare costs. For more information, visit www.myriad.com.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to how the ability of Precise MRD to detect ctDNA levels in patients with very low tumor burden may allow patients who are candidates for MRWS to delay or avoid systemic treatments, sparing patients from serious side effects and supporting treatment de-escalation; that ctDNA may be a promising biomarker to identify those who will benefit most from MDT; that the performance of Precise MRD in this clinical setting is an encouraging indicator of its sensitivity in a range of other indications, such as breast cancer; and the company’s excitement to continue characterizing the performance of Precise MRD in renal cancer. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2025, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

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