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

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) has been granted a third patent by the U.S. Patent and Trademark Office, strengthening its position in delivering a tumor-informed, high-definition, molecular residual disease (MRD) assay. The new patent, U.S. patent no. 12,104,212, covers proprietary methods for ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA).

This patent complements two earlier patents related to MRD technology and cell-free DNA preparation methods. Myriad's Precise® MRD assay can track up to thousands of tumor-specific variants, potentially detecting ctDNA at lower levels than other products currently available. The company is leveraging its existing technology, including the FDA-approved MyChoice® CDx companion diagnostic and FirstGeneTM platforms, to develop and commercialize Precise MRD.

Myriad is currently conducting several high-impact studies for its Precise MRD assay, including collaborations with Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, and the National Cancer Center Hospital East in Japan. The test is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators.

Positive

• Granted third patent for molecular residual disease (MRD) technology
• Precise® MRD assay can detect ctDNA at potentially lower levels than competitors
• Leveraging existing FDA-approved technology for MRD assay development
• Multiple ongoing high-impact studies and collaborations with prestigious institutions

Negative

• None.

Insights

Medical Research Analyst

The grant of this third patent for Molecular Residual Disease (MRD) technology significantly bolsters Myriad Genetics' intellectual property portfolio in the growing field of cancer diagnostics. This patent, focusing on ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA), complements two earlier patents and strengthens Myriad's position in the competitive MRD market.

The Precise® MRD assay, capable of tracking up to thousands of tumor-specific variants, potentially offers superior sensitivity compared to existing products. This could translate to earlier detection of cancer recurrence and more precise monitoring of treatment efficacy, which are important for improving patient outcomes in oncology.

Myriad's strategic approach of leveraging existing FDA-approved platforms like MyChoice® CDx and FirstGene™ for Precise MRD development may accelerate its path to market. The ongoing high-impact studies and collaborations with prestigious institutions like Memorial Sloan Kettering and MD Anderson Cancer Center add credibility and could provide valuable data for future regulatory submissions and market adoption.

While the MRD market is promising, it's important to note that Myriad faces stiff competition from established players. The company's ability to successfully commercialize Precise MRD and capture market share will depend on clinical performance, cost-effectiveness and reimbursement strategies.

Financial Analyst

The expansion of Myriad Genetics' patent portfolio in the MRD space is a positive development for the company's long-term growth prospects. The MRD market is projected to grow significantly, with some estimates suggesting a CAGR of over 20% in the coming years. This patent strengthens Myriad's competitive position and potential for market share capture.

Financially, the successful commercialization of Precise MRD could diversify Myriad's revenue streams and potentially improve its profit margins. The company's statement about profitable commercialization suggests confidence in the test's economic viability. However, investors should consider the substantial R&D and marketing investments required to bring Precise MRD to market and achieve widespread adoption.

Myriad's market cap of $2.45 billion reflects its current business, primarily in hereditary cancer testing. A successful entry into the high-growth MRD market could significantly impact the company's valuation. However, it's important to monitor the progress of ongoing studies and regulatory approvals, as these will be key milestones for realizing the commercial potential of Precise MRD.

While this patent news is positive, it's important to note that Myriad's stock performance will also depend on the performance of its existing product lines and overall market conditions in the diagnostics sector.

SALT LAKE CITY, Oct. 01, 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 third patent that will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to market. 

U.S. patent no. 12,104,212, entitled “Personalized Methods for Detecting Circulating Tumor DNA,” demonstrates Myriad’s continued efforts to advance its MRD strategy on multiple fronts. The claims of the patent cover proprietary methods that generate ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA).

Earlier this year, Myriad Genetics announced the grant of two complementary 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 Precise^® MRD.

“The issuance of this third MRD patent supports Myriad’s efforts to establish a proprietary and differentiated MRD assay that tracks up to thousands of tumor-specific variants, making it capable of detecting ctDNA at lower levels than other products in the market today,” said Paul J. Diaz, President and CEO, Myriad Genetics. “We have developed our Precise MRD assay by leveraging Myriad’s existing technology and building upon our FDA-approved MyChoice^® CDx companion diagnostic and FirstGene^TM 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.

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 issuance of a patent will strengthen Myriad’s ability to deliver a tumor-informed, high-definition, MRD assay to market and support Myriad’s efforts to establish a proprietary and differentiated MRD assay, and that Myriad’s unique set of capabilities will enable it to profitably commercialize Precise MRD, advancing oncology care for patients in this emerging and under-penetrated market. 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 is the new patent granted to Myriad Genetics (MYGN) for MRD technology?

Myriad Genetics has been granted U.S. patent no. 12,104,212, titled 'Personalized Methods for Detecting Circulating Tumor DNA,' which covers proprietary methods for ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA).

How many tumor-specific variants can Myriad's Precise MRD assay track?

Myriad's Precise MRD assay can track up to thousands of tumor-specific variants, potentially enabling detection of ctDNA at lower levels than other products currently available in the market.

What existing technologies is Myriad Genetics (MYGN) leveraging for its MRD assay?

Myriad Genetics is leveraging its FDA-approved MyChoice® CDx companion diagnostic and FirstGeneTM platforms to develop and commercialize its Precise MRD assay.

Which institutions is Myriad Genetics (MYGN) collaborating with for MRD studies?

Myriad Genetics is collaborating with Memorial Sloan Kettering, The University of Texas MD Anderson Cancer Center, and the National Cancer Center Hospital East in Japan for various MRD studies.