Myriad Genetics Highlights MRD Clinical Validity Data at American Association for Cancer Research Annual Meeting
SALT LAKE CITY, April 25, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostic testing and precision medicine, announced new clinical data will be shared at the American Association for Cancer Research (AACR) Annual Meeting that highlights the performance of the Precise MRD test in patients with oligometastatic clear-cell renal cell carcinoma (ccRCC).
A podium presentation titled "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" will be presented by Dr. Chad Tang, M.D., associate professor in the department of genitourinary radiation oncology at The University of Texas MD Anderson Cancer Center (MDACC) on April 28. The abstract presentation number is CT132.
MRWS offers substantial advantages for patients compared to more aggressive frontline systemic therapies; however, no clinically-utilized prognostic markers exist to identify patients who would benefit from such treatment de-escalation strategies1. Moreover, oligometastatic ccRCC poses a unique challenge for MRD assays because tumors tend to be heterogeneous, slow growing, low shedding, and generally limited in trackable mutations1. Myriad's ultrasensitive ctDNA MRD assay can detect very low ctDNA levels by employing large, tumor-informed panels and offers new possibilities for patients who might be optimal candidates for MRWS in lieu of systemic therapy, potentially avoiding serious side effects and high costs.
"This study demonstrated that metastasis-directed radiation therapy (MDT) can help patients delay or avoid systematic treatments without sacrificing outcomes. Overall survival was not compromised, with survival rates of 94% at two years and 87% at three years," said Tang. "The study also suggests that ultrasensitive ctDNA detection is a promising personalized biomarker that may offer opportunities for de-escalated, personalized care in patients with a cancer type that does not otherwise have many good biomarkers. Our data show those who tested positive on Precise MRD prior to MRWS initiated systemic therapy within a median time of 27 months, whereas those who tested negative on Precise MRD were maintained on MDT for a median time of 54 months."
"We are delighted that this clinical readout of Precise MRD was selected as a late-breaking oral presentation at AACR," said Dale Muzzey, chief scientific officer, Myriad Genetics. "In this study, our ultrasensitive MRD assay identified more than 50% of patients as MRD-positive at their baseline visit, which is impressive given that the very low tumor fractions common in ccRCC are often below the detection limits of first-generation MRD tests. Many of these patients may have gotten false negatives if tested on earlier MRD assays, and that is clinically meaningful because MRD positivity in this study was associated with substantially longer duration prior to the initiation of more aggressive systemic therapy. The performance of Precise MRD in this challenging clinical setting gives us optimism about its potential validity and utility in a range of other applications."
In addition to the podium presentation by Dr. Tang, two Precise MRD posters will be on display on April 30 from 9:00am – 12:00pm in Section 10:
- Poster #6639: Optimized selection of tumor-informed MRD panels enhances sensitivity of ctDNA detection
Summary: Myriad's Precise MRD test is an ultrasensitive second-generation hybrid-capture-based tumor-informed assay that detects ctDNA in the plasma and uses a novel ranking algorithm to select up to 1,000 high-confidence targets based on tumor-specific and target-specific features to optimize panel design for residual disease detection. - Poster #6641: Inclusion of INDEL somatic variants in MRD panels improves confidence in ctDNA residual release detection
Summary: Including insertion/deletion (INDEL) mutations in the tumor-informed, patient-specific tumor panels used to monitor for MRD in patients with cancer increases the likelihood of detecting low abundance ctDNA and achieving high sensitivity at low tumor concentrations.
Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. Myriad continues to develop its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. The test is currently being evaluated in several high-impact studies and is performed at the company's state-of-the-art laboratory facility in Salt Lake City.
1 "Charting the Path to Systemic Therapy De-escalation—Oligometastatic Kidney Cancer as a Paradigm" by Tang and Msaouel PMID: 38451536
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 planning. 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 about the study and how it suggests that ultrasensitive ctDNA detection is a promising personalized biomarker that may offer opportunities for de-escalated, personalized care in patients with cancer types that does not otherwise have many good biomarkers, the potential of the company's ultrasensitive ctDNA MRD assay to offer new possibilities for patients who might be optimal candidates for MRWS in lieu of systemic therapy, potentially reducing serious side effects and high costs, and the company's optimism regarding Precise MRD's potential validity and utility in a range of other applications. 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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