Myriad Genetics Announces Second Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) has secured a second key patent for its molecular residual disease (MRD) technology, enhancing its ability to deliver high-definition, tumor-informed MRD assays. The newly issued U.S. patent no. 12,024,749, titled “Combinatorial DNA Screening,” complements a previously granted patent on methods of preparing cell-free DNA, solidifying Myriad's unique position in the MRD market. This innovative technology detects circulating tumor DNA with high sensitivity, providing a competitive edge. The company continues to refine its Precise MRD assay, currently involved in multiple high-impact studies, and anticipates releasing preliminary results this fall.

Positive

• Second foundational patent strengthens Myriad's intellectual property portfolio.
• Patent enhances Myriad's competitive edge in high-sensitivity MRD assays.
• Precise MRD assay detects tumor DNA at lower levels than current market products.
• Multiple high-impact studies ongoing, showing robust development activity.
• Potential for profitable commercialization and licensing opportunities.

Negative

• Preliminary results from collaborations are pending, adding a layer of uncertainty.

Medical Research Analyst

Myriad Genetics' new patent for its Molecular Residual Disease (MRD) assay marks a significant stride in cancer diagnostics. This patent enhances the company's technological framework for detecting circulating tumor DNA with high sensitivity and specificity. Such advancements are important as they allow for more accurate monitoring of cancer post-treatment, improving patient outcomes by identifying residual disease early.

The MRD assay leverages genome-scale sequencing technology to track thousands of tumor-specific variants, setting it apart from competitors by detecting tumor DNA at exceptionally low levels. This technology could revolutionize oncology care by providing more precise and timely information about disease recurrence, which is critical for guiding subsequent treatment decisions and improving survival rates.

Looking ahead, as more high-impact studies and collaborations with distinguished institutions like Memorial Sloan Kettering and MD Anderson Cancer Center yield results, the credibility and adoption of Myriad's MRD assay in the clinical setting are likely to increase. Investors should watch for upcoming study results and potential FDA feedback, which could further validate the technology and accelerate its adoption.

Financial Analyst

From a financial perspective, Myriad Genetics' new patent strengthens its intellectual property portfolio, potentially leading to increased revenue streams from licensing opportunities and new product offerings. This development solidifies Myriad's competitive advantage in the precision medicine market, particularly in the emerging field of MRD assays.

Given that the company plans to commercialize the Precise MRD assay, leveraging its established technology and infrastructure, there's an expectation of profitability. The MRD market is under-penetrated, providing ample growth opportunities. Successful commercialization could significantly boost Myriad's market share and financial performance.

Investors should be mindful of the high development costs and the time required for widespread adoption. However, the strategic collaborations and ongoing studies could mitigate these risks by providing early validation and facilitating entry into the market. Monitoring quarterly earnings for updates on the assay's performance and market reception will be crucial.

SALT LAKE CITY, July 09, 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 second patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market. 

U.S. patent no. 12,024,749, entitled “Combinatorial DNA Screening,” covers Myriad’s groundbreaking platform MRD technology, which enables highly sensitive and specific tumor-informed, sequencing-based MRD assays such as Precise MRD. Specifically, the patented method relates to detecting circulating tumor DNA in patient fluid samples, including blood and plasma.

Earlier this year, Myriad Genetics announced its complementary patent granted for the company’s methods of preparing cell-free DNA that also enables high sensitivity tumor informed MRD assays. Together, these two patents support Myriad’s pioneering efforts to establish a proprietary and differentiated MRD assay that tracks thousands of tumor-specific variants identified via genome-scale sequencing technology, making it capable of detecting tumor DNA at lower levels than other products in the market today.

“The issuance of this second patent supporting our MRD assay development showcases another dimension 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,” said Paul J. Diaz, president and CEO, Myriad Genetics. “We have developed our Precise^® MRD assay by leveraging Myriad’s existing technology – laboratory systems, infrastructure, and intellectual property – and by building upon our FDA-approved MyChoice^® CDx 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 and under-penetrated market.”

Myriad continues to develop its Precise MRD assay to meet the needs of cancer patients, academic partners, and biopharma companies. The test is currently undergoing several high-impact studies while also transitioning to the company’s state-of-the-art laboratory facility in Salt Lake City. Myriad has announced several MRD collaborations, including a metastatic breast cancer study with researchers at Memorial Sloan Kettering, a metastatic renal cell carcinoma study with clinicians at The University of Texas MD Anderson Cancer Center, and a prospective pan-cancer study led by researchers at the National Cancer Center Hospital East in Japan. Preliminary results from multiple collaborations are expected to be released this fall.

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 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 its Precise MRD offering, advancing oncology care for patients in this emerging under-penetrated market, and the company expects to have preliminary results of several high-impact Precise MRD studies from multiple collaborations released this fall. 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 
Glenn Farrell 
(385) 318-3718 
PR@myriad.com 

FAQ

What recent patent did Myriad Genetics obtain for MRD technology?

Myriad Genetics obtained U.S. patent no. 12,024,749, titled 'Combinatorial DNA Screening,' enhancing their MRD assay capabilities.

How does Myriad Genetics' new patent benefit its MRD assays?

The new patent strengthens Myriad's MRD assay by enabling highly sensitive and specific detection of tumor DNA in patient fluid samples.

What ongoing studies are associated with Myriad Genetics' Precise MRD assay?

Myriad's Precise MRD assay is involved in multiple high-impact studies, including research on metastatic breast cancer and renal cell carcinoma.

When will preliminary results from Myriad Genetics' MRD collaborations be available?

Preliminary results from Myriad Genetics' MRD collaborations are expected to be released this fall.

What is the significance of Myriad Genetics' new patent for investors?

The new patent enhances Myriad's competitive position in the MRD market, potentially leading to profitable commercialization and licensing opportunities.