Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date
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Insights
The issuance of a patent for Myriad Genetics' method of preparing cell free DNA for tumor-informed MRD assays represents a significant advancement in the field of precision medicine. The ability to detect circulating tumor DNA with high sensitivity and specificity is paramount for the early detection and monitoring of cancer. This technology could potentially lead to improvements in patient outcomes due to more personalized treatment plans based on the molecular profile of an individual's cancer.
From a research perspective, this patent solidifies Myriad Genetics' intellectual property portfolio, potentially providing a competitive edge in the market for MRD assays. It is also indicative of the company's commitment to innovation, which could attract further investment and partnerships. However, the actual impact on the business will depend on the assay's efficacy, market adoption and how it compares to existing competitors' technologies.
The grant of U.S. patent 11,932,910 to Myriad Genetics underscores the importance of protecting intellectual property in the biotechnology industry. A strong patent portfolio is a critical asset for companies operating in this space, as it can deter competition and provide exclusive market rights for a certain period. The patent covers a foundational method in the preparation of cell free DNA, which is a cornerstone in the development of MRD assays.
However, the scope and enforceability of the patent are key factors that will determine its actual business impact. It will be important to monitor any challenges to the patent's validity or potential infringement cases, as these could affect Myriad Genetics' ability to capitalize on its proprietary technology. Additionally, the patent's international status and corresponding protection will affect global market opportunities.
The development of a high-definition MRD assay by Myriad Genetics could be a game-changer in the management of cancer. MRD assays are important for detecting minimal residual disease, which is a small number of cancer cells that remain in the patient after treatment and can lead to relapse. The patent for a method that enriches cell free DNA samples with ctDNA enhances the potential for early detection and accurate monitoring of cancer recurrence.
As a clinician, the availability of such sensitive and specific tests could inform treatment decisions and follow-up strategies, potentially leading to more tailored and effective interventions. However, the clinical adoption of this assay will depend on its integration into treatment guidelines and reimbursement policies. It will also be essential to evaluate how this assay performs in real-world settings compared to traditional monitoring methods.
SALT LAKE CITY, March 21, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today 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.
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,” said 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.”
Myriad has made significant strides in developing its Precise MRD assay. The test is currently being installed in the company’s new state-of-the-art 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 has announced several important research collaborations: 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, and 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,” said 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,” said 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.”
About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic 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 that the granted patent will strengthen the company’s ability to deliver a tumor-informed, high-definition, MRD assay to market, the company believes the issued patent will help advance the company’s position as a precision medicine leader—both via its own Precise MRD offering and via potential licensing opportunities—in the MRD space, the company believes that its unique set of capabilities will enable it to profitably commercialize a MRD offering, advancing oncology care for patients in this emerging under-penetrated market, the company expects to have results from its renal MRD study later this year, the company is on track to process samples for biopharma partners by Q4’24 and to submit to MolDx by year end, with a commercial launch targeted for the second half of 2025, and the company expects to soon launch its Precise Liquid test. 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, 2024, 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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(801) 584-3532
IR@myriad.com
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