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Myriad Genetics, MD Anderson Partner to Study Clinical Utility of MRD Assay

NEW YORK – Myriad Genetics and the University of Texas MD Anderson Cancer Center on Tuesday announced a five-year strategic alliance to further develop and to evaluate the clinical utility of Myriad's Precise MRD assay for measuring minimal residual disease.

Under the terms of the agreement, the partners will design both retrospective and prospective studies investigating the test's clinical utility in breast, gastrointestinal, genitourinary, and gynecological cancers. These studies also aim to generate evidence to support inclusion of the test in national guidelines and healthcare provider adoption.

MD Anderson investigators will lead patient recruitment, sample collection, clinical data analysis, and manuscript writing. Myriad will provide funding, MRD testing, and scientific research support, as well as potential milestone and royalty payments.

Financial details of the agreement were not disclosed.

Precise MRD is a tumor-informed, whole-genome sequencing test that monitors hundreds to thousands of tumor-specific variants to detect and quantify circulating tumor DNA (ctDNA) in patient blood samples.

The deal expands on an existing research collaboration between MD Anderson and Myriad, announced last year, under which MD Anderson is conducting a study to determine whether ctDNA levels can predict a patient's response to Merck's Keytruda (pembrolizumab) and hormonal therapy in certain breast cancers.

Myriad also entered into research collaborations with four other institutions last year to assess the Precise MRD test in breast cancer monitoring.

"We aim to explore numerous applications for MRD testing, including monitoring patients for relapse after treatment, identifying high-risk patients in need of clinical trials, and potentially intervention approaches," Christopher Flowers, division head of cancer medicine at MD Anderson, said in a statement.

Myriad CSO Dale Muzzey added that the company is "optimistic that our MRD test’s ability to quantitatively detect tumor-derived DNA at very low levels — far lower than is possible with first-generation MRD tests — will open new opportunities for therapy-response and recurrence monitoring."