Myriad Genetics, a provider in genetic testing and precision medicine, announced that the United States Patent and Trademark Office has issued a patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market. 

Patent Aims to Strengthen Myriad’s Precision Medicine Capabilities

U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers Myriad’s foundational and proprietary method of preparing cell free DNA. This method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing. Specifically, the patented method relates to the manner in which a sample is sufficiently enriched with ctDNA that it can be detected, if present, with high sensitivity and specificity.

“The 2016 filing date of this patent—at the advent of MRD development—highlights Myriad’s foresight about the potential role of tumor-derived cell-free DNA in the expanding field of cancer diagnostics,” says Paul J. Diaz, president and CEO, Myriad Genetics. “The issuance of this patent showcases some of Myriad’s novel proprietary technology that we believe will help advance Myriad’s position as a precision medicine leader—both via its own Precise MRD offering and via potential licensing opportunities in the MRD space. We have developed our Precise MRD assay by leveraging Myriad’s existing technology, laboratory systems and processes, infrastructure and intellectual property, building upon our FDA-approved MyChoice companion diagnostic and FirstGene platforms. We believe that our unique set of capabilities will enable us to profitably commercialize Precise MRD, advancing oncology care for patients in this emerging under-penetrated market.”

Further reading: Myriad Genetics Acquires Diagnostic Assets from Intermountain Precision Genomics

Progress in Test Development and Research Collaborations

Myriad has made several strides toward developing its Precise MRD assay:

  • The test is currently being installed in the company’s new laboratory facility in Salt Lake City, where it will soon undergo further validation to enable its use in a range of applications, including biopharma studies and interventional prospective trials. 
  • Myriad announced several important research collaborations for the assay.
    • A retrospective study of MRD efficacy in metastatic breast cancer with researchers at Memorial Sloan Kettering
    • A retrospective analysis of MRD utility in metastatic renal cell carcinoma with clinicians at The University of Texas MD Anderson Cancer Center
    • A prospective pan-cancer study beginning in May with pioneering MRD researchers at the National Cancer Center East in Japan.

“We will be presenting initial learnings from our retrospective MRD studies in conferences this spring and summer, and we expect to have full results from the renal study later this year,” says Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. “We are on track to process samples for biopharma partners by Q4’24 and to submit to MolDx by year end, with commercial launch targeted for the second half of 2025. The approach described in the granted patent is core to our Precise MRD test, though in the years since that initial filing we have continued to refine the test, incorporating and protecting these innovations along the way.”

Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. 

“The sensitivity and detection limit achieved with Precise MRD allows it to perform across a wide range of indications, including those with scarce ctDNA that were not well suited to first-generation tests,” says Muzzey. “We intend for it to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through survivorship monitoring. We see significant opportunity to pair Precise MRD with MyRisk, our market-leading hereditary cancer test, and our recently acquired Precise Tumor and soon to launch Precise Liquid tests, to offer a comprehensive set of easy to use clinical decision support tools for oncologists to advance the care of patients.”