Myriad Genetics Announces Two New Patents Granted for its Molecular Residual Disease (MRD) Assay
Rhea-AI Summary
Myriad Genetics (NASDAQ: MYGN) has been granted two new patents by the United States Patent and Trademark Office for its molecular residual disease (MRD) assay technology. The first patent (No. 12,215,391) covers proprietary automated methods of MRD analysis, specifically focusing on automation systems interfacing with laboratory equipment. The second patent (No. 12,215,392) relates to patient journey aspects of MRD, covering methods performed before, during, or after treatment, or during remission.
These patents follow three earlier patents awarded in 2024 for foundational platform MRD technology and cell-free DNA preparation methods. The company's Precise® MRD test is designed to determine treatment effectiveness and cancer recurrence. The test is currently under evaluation in several studies and has completed transition to Myriad's Salt Lake City laboratory facility.
Positive
- Secured two new strategic patents strengthening MRD testing intellectual property portfolio
- Previously obtained three related patents in 2024, building comprehensive IP protection
- Successfully completed laboratory facility transition for Precise MRD test in Salt Lake City
Negative
- Product still in evaluation phase, not yet generating revenue
Insights
The first patent (No. 12,215,391) covering automated MRD analysis methods is particularly valuable as it protects scalable, high-throughput testing capabilities - a critical factor for commercial success in the diagnostic market. Automation patents typically translate to improved operational efficiency and reduced costs, potentially leading to higher profit margins.
The second patent (No. 12,215,392) focusing on patient journey aspects creates a comprehensive protective moat around various testing timepoints - before, during and after treatment, as well as during remission. This broad coverage effectively positions Myriad to capture multiple testing opportunities throughout a patient's cancer journey, potentially leading to recurring revenue streams.
Combined with their three existing MRD-related patents from 2024, Myriad has built a robust five-patent portfolio specifically around their Precise® MRD test. This intellectual property strategy appears designed to create high barriers to entry for competitors while protecting various aspects of their technology - from foundational platform technology to specific implementation methods.
The market impact is particularly noteworthy as the global MRD testing market is projected to see substantial growth, driven by increasing cancer prevalence and the shift toward personalized medicine. By securing these patents, Myriad positions itself to potentially capture a larger share of this expanding market through both direct testing services and potential licensing opportunities.
The strategic significance of Myriad's MRD patent portfolio extends beyond mere intellectual property protection - it addresses critical unmet needs in cancer care. The ultrasensitive Precise MRD test's ability to monitor both treatment effectiveness and cancer recurrence positions it as a valuable tool in the precision oncology arsenal.
The technology's implementation in the new state-of-the-art laboratory facility in Salt Lake City suggests a commitment to maintaining high-quality standards and scalability. The ongoing evaluation in multiple high-impact studies indicates a robust clinical validation strategy, which is important for market adoption and potential insurance coverage.
The timing of these patents is particularly strategic as the oncology field increasingly emphasizes early detection and monitoring. The ability to detect molecular residual disease with high sensitivity could potentially lead to earlier intervention in cases of cancer recurrence, improving patient outcomes and reducing treatment costs.
For investors, the expansion of Myriad's oncology testing portfolio represents diversification beyond their traditional hereditary cancer testing business. The MRD testing market presents significant growth potential, particularly given the increasing adoption of precision medicine approaches in oncology and the growing need for more accurate treatment response monitoring.
SALT LAKE CITY, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic and tumor genomic testing and precision medicine, announced that the United States Patent and Trademark Office has issued two new patents that further advance Myriad’s ability to bring its tumor-informed, high-definition, molecular residual disease (MRD) assay to market.
- US patent No. 12,215,391 relates to Myriad’s proprietary automated methods of MRD analysis. Specifically, the claims are relevant to certain MRD methods that are performed via an automation system configured to interface with laboratory equipment.
- US patent No. 12,215,392 relates to patient journey aspects of MRD. Specifically, the claims are relevant to certain MRD methods performed before, during or after treatment, or during remission.
In 2024, Myriad Genetics was awarded three patents related to foundational platform MRD technology and cell-free DNA preparation methods that each enable highly sensitive and specific tumor-informed, sequencing-based MRD assays, such as Myriad’s Precise® MRD test.
“These additional patents underscore Myriad’s novel proprietary technology that we believe will help advance Myriad’s position as a precision medicine leader. Our Precise MRD assay will work to answer the two fundamental questions that clinicians and patients have in the fight against cancer: 1) is treatment working? and 2) has cancer recurred?” said Paul J. Diaz, President and CEO, Myriad Genetics. “We believe our ultrasensitive Precise MRD test will enhance treatment strategies for providers and improve patient outcomes, as well as open new opportunities for therapy-response and recurrence monitoring.”
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 recently completed transitioning to the company’s state-of-the-art laboratory facility in Salt Lake City.
About Precise Molecular Residual Disease (MRD) Test
Myriad’s Precise MRD test is whole-genome sequencing (WGS)-based assay, enabling the custom selection of hundreds to thousands of targeted variants for deep analysis. Myriad’s MRD assay targets 1,000 sites specific to the tumor genome, enabling sensitive detection of very low tumor levels. Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators.
About Myriad Genetics
Myriad Genetics is a leading genetic and tumor genomic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics 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 statements relating to the company’s belief that these additional patents underscore the company’s proprietary technology and will help advance its position as a precision medicine leader, the anticipate benefits of its Precise MRD assay in addressing fundamental questions in cancer care related to treatment efficacy and cancer recurrence, the potential for its ultrasensitive assay to enhance treatment strategies, improve patient outcomes, and create new opportunities for therapy-response and recurrence monitoring, and the company’s ongoing efforts to develop its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. 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.
Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com
Media Contact
Kate Schraml
(224) 875-4493
PR@myriad.com
FAQ
What are the two new patents granted to Myriad Genetics (MYGN) for MRD testing?
How many MRD-related patents has MYGN received in total since 2024?
What is the current development status of MYGN's Precise MRD test?
What are the main clinical applications of MYGN's Precise MRD test?
