Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date
Myriad Genetics, Inc. secures a patent from the USPTO for a tumor-informed MRD assay, enhancing its precision medicine capabilities. The patent covers a method for preparing cell free DNA to detect circulating tumor DNA with high sensitivity and specificity.
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.
03/21/2024 - 09:40 PM
SALT LAKE CITY, March 21, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc.
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.”
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What did Myriad Genetics announce?
Myriad Genetics announced the issuance of a patent by the United States Patent and Trademark Office for a tumor-informed, high-definition, molecular residual disease (MRD) assay.
What does the patent cover?
The patent covers Myriad's method of preparing cell free DNA to detect circulating tumor DNA (ctDNA) with high sensitivity and specificity.
What is the patent number?
The patent number is 11,932,910.
What is the significance of the patent filing date?
The patent filing date in 2016 showcases Myriad's foresight in MRD development.
What is the focus of the patented method?
The patented method focuses on enriching samples with ctDNA to enable sensitive and specific detection.
