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

Key Takeaway: Myriad Genetics has announced the granting of a second foundational patent by the United States Patent and Trademark Office for its molecular residual disease (MRD) technology. This patent, coupled with an earlier one, boosts Myriad's ability to provide a high-definition MRD assay capable of detecting tumor DNA in various patient fluid samples. The company aims to commercialize its Precise MRD assay while conducting several high-impact studies in collaboration with leading research institutions. Preliminary results from these collaborations are expected to be released in the fall of 2024.
Price reaction · baseline $25.26 (2024-07-08 close) · hit after-hours · 1 other MYGN headline(s) in the window, move may be shared
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Market Sentiment Analysis

POSITIVE FACTORS

  • Myriad Genetics received a second foundational patent to enhance its MRD assay capabilities.
  • The patented technology allows for highly sensitive tumor-informed MRD detection.
  • Myriad's developments are expected to bolster its position in precision medicine and oncology care.
  • The company has multiple collaborations to advance its MRD studies with prominent research institutions.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~41 mo
Minimal dilution risk
Lead asset
SKB264
Phase 2 · Solid Tumor

Full Press Release Details

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.

Frequently Asked Questions

What is the new patent issued to Myriad Genetics?

The new patent, U.S. patent no. 12,024,749, covers Myriad's MRD technology for detecting circulating tumor DNA.

What does the Precise MRD assay detect?

The Precise MRD assay detects tumor DNA at lower levels by tracking tumor-specific variants.

What is the purpose of Myriad's MRD assay?

The MRD assay aims to advance oncology care for cancer patients through precision medicine.

Where is the Precise MRD assay being developed?

It is being developed at Myriad's laboratory facility in Salt Lake City.

Which studies is Myriad collaborating on?

Myriad is collaborating on studies for metastatic breast cancer and renal cell carcinoma.

Last updated: Jul 9, 2024