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Myriad Genetics (MYGN) Wins Foundational Patent for MRD Assay
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Myriad Genetics, Inc. (MYGN - Free Report) recently announced the issuance of a patent by the United States Patent and Trademark Office, which will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to the market. U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers the company’s foundational and proprietary method of preparing cell-free DNA.
The latest development showcases some of Myriad Genetics’ novel proprietary technology that could strengthen its position as a precision medicine leader — both via its Precise MRD offering and potential licensing opportunities in the MRD space.
News in Detail
Myriad Genetics’ patented method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing. Specifically, it relates to the manner in which a sample is sufficiently enriched with ctDNA so that it can be detected, if present, with high sensitivity and specificity. The company filed the patent in 2016 at the advent of MRD development, envisioning the potential role of tumor-derived cell-free DNA in the expanding field of cancer diagnostics.
Image Source: Zacks Investment Research
The Precise MRD assay leverages MYGN’s existing technology, laboratory systems and processes, infrastructure and intellectual property and builds upon its FDA-approved MyChoice companion diagnostic and FirstGene platforms. According to the company’s representative, their distinctive capabilities enable them to profitably commercialize Precise MRD, advancing oncology care for patients in the emerging under-penetrated MRD market.
Advancements in the Precise MRD Test
The company has made significant strides in developing its Precise MRD assay. The test is currently being installed in the 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.
Moreover, Myriad Genetics announced several important research collaborations, including a retrospective study of MRD efficacy in metastatic breast cancer with researchers at Memorial Sloan Kettering and a retrospective analysis of MRD utility in metastatic renal cell carcinoma with clinicians at The University of Texas MD Anderson Cancer Center. The company plans to present initial findings from retrospective MRD studies at the upcoming conferences and anticipates full results from the renal study later this year.
MYGN is on track to process samples for biopharma partners by the fourth quarter of 2024 and submit them by year-end to the MolDX (Molecular Diagnostic Services Program), which was developed to identify and establish coverage and reimbursement for molecular diagnostic tests. Commercial launch is targeted for the second half of 2025. The approach described in the granted patent is fundamental to the Precise MRD test, which has been refined over the years since the initial filing.
Precise MRD is available for use in joint research studies between Myriad and academic or pharmaceutical investigators. The company plans Precise MRD to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through survivorship monitoring. MYGN recognizes a significant opportunity to pair Precise MRD with the MyRisk hereditary cancer test and the recently acquired Precise Tumor and upcoming Precise Liquid tests to offer a comprehensive set of easy-to-use clinical decision support tools for oncologists to advance the care of patients.
Industry Prospects
Per a research report, the global MRD testing market was valued at $1.89 billion in 2022 and is expected to witness a CAGR of 11.5% up to 2030.
Notable Developments
Last month, Myriad Genetics announced a research collaboration with the National Cancer Center Hospital East in Japan to study the prognostic and predictive value of MRD testing. The SCRUM-MONSTAR-SCREEN-3 study will use Precise MRD to monitor ctDNA over time in patients diagnosed with a wide array of solid tumors and hematological cancers. The study aims to generate high-quality, prospective clinical evidence showing MRD testing can be broadly applied across cancer types and to patients with different disease severity or staging.
Price Performance
In the past six months, MYGN shares have increased 27.9% compared with the industry’s rise of 1.8%.
Zacks Rank and Key Picks
Myriad Genetics currently carries a Zacks Rank #3 (Hold).
Cardinal Health’s stock has surged 54% in the past year. Earnings estimates for Cardinal Health have risen from $7.28 to $7.29 in fiscal 2024 and from $8.02 to $8.04 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.67%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 26.3% upward in the past year compared with the industry’s rise of 5.2%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.09%. In the last reported quarter, it delivered an average earnings surprise of 5.81%.
Estimates for DaVita’s 2024 earnings per share have moved up from $8.97 to $9.23 in the past 30 days. Shares of the company have surged 74.8% in the past year compared with the industry’s 22.3% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 35.57%. In the last reported quarter, it delivered an average earnings surprise of 22.22%.
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Myriad Genetics (MYGN) Wins Foundational Patent for MRD Assay
Myriad Genetics, Inc. (MYGN - Free Report) recently announced the issuance of a patent by the United States Patent and Trademark Office, which will strengthen its ability to deliver a tumor-informed, high-definition, molecular residual disease (MRD) assay to the market. U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers the company’s foundational and proprietary method of preparing cell-free DNA.
The latest development showcases some of Myriad Genetics’ novel proprietary technology that could strengthen its position as a precision medicine leader — both via its Precise MRD offering and potential licensing opportunities in the MRD space.
News in Detail
Myriad Genetics’ patented method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing. Specifically, it relates to the manner in which a sample is sufficiently enriched with ctDNA so that it can be detected, if present, with high sensitivity and specificity. The company filed the patent in 2016 at the advent of MRD development, envisioning the potential role of tumor-derived cell-free DNA in the expanding field of cancer diagnostics.
Image Source: Zacks Investment Research
The Precise MRD assay leverages MYGN’s existing technology, laboratory systems and processes, infrastructure and intellectual property and builds upon its FDA-approved MyChoice companion diagnostic and FirstGene platforms. According to the company’s representative, their distinctive capabilities enable them to profitably commercialize Precise MRD, advancing oncology care for patients in the emerging under-penetrated MRD market.
Advancements in the Precise MRD Test
The company has made significant strides in developing its Precise MRD assay. The test is currently being installed in the 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.
Moreover, Myriad Genetics announced several important research collaborations, including a retrospective study of MRD efficacy in metastatic breast cancer with researchers at Memorial Sloan Kettering and a retrospective analysis of MRD utility in metastatic renal cell carcinoma with clinicians at The University of Texas MD Anderson Cancer Center. The company plans to present initial findings from retrospective MRD studies at the upcoming conferences and anticipates full results from the renal study later this year.
MYGN is on track to process samples for biopharma partners by the fourth quarter of 2024 and submit them by year-end to the MolDX (Molecular Diagnostic Services Program), which was developed to identify and establish coverage and reimbursement for molecular diagnostic tests. Commercial launch is targeted for the second half of 2025. The approach described in the granted patent is fundamental to the Precise MRD test, which has been refined over the years since the initial filing.
Precise MRD is available for use in joint research studies between Myriad and academic or pharmaceutical investigators. The company plans Precise MRD to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through survivorship monitoring. MYGN recognizes a significant opportunity to pair Precise MRD with the MyRisk hereditary cancer test and the recently acquired Precise Tumor and upcoming Precise Liquid tests to offer a comprehensive set of easy-to-use clinical decision support tools for oncologists to advance the care of patients.
Industry Prospects
Per a research report, the global MRD testing market was valued at $1.89 billion in 2022 and is expected to witness a CAGR of 11.5% up to 2030.
Notable Developments
Last month, Myriad Genetics announced a research collaboration with the National Cancer Center Hospital East in Japan to study the prognostic and predictive value of MRD testing. The SCRUM-MONSTAR-SCREEN-3 study will use Precise MRD to monitor ctDNA over time in patients diagnosed with a wide array of solid tumors and hematological cancers. The study aims to generate high-quality, prospective clinical evidence showing MRD testing can be broadly applied across cancer types and to patients with different disease severity or staging.
Price Performance
In the past six months, MYGN shares have increased 27.9% compared with the industry’s rise of 1.8%.
Zacks Rank and Key Picks
Myriad Genetics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Cardinal Health (CAH - Free Report) , Stryker (SYK - Free Report) and DaVita (DVA - Free Report) . While Cardinal Health and Stryker each carry a Zacks Rank #2 (Buy), DaVita sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Cardinal Health’s stock has surged 54% in the past year. Earnings estimates for Cardinal Health have risen from $7.28 to $7.29 in fiscal 2024 and from $8.02 to $8.04 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.67%.
Estimates for Stryker’s 2024 earnings per share have remained constant at $11.86 in the past 30 days. Shares of the company have moved 26.3% upward in the past year compared with the industry’s rise of 5.2%.
SYK’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 5.09%. In the last reported quarter, it delivered an average earnings surprise of 5.81%.
Estimates for DaVita’s 2024 earnings per share have moved up from $8.97 to $9.23 in the past 30 days. Shares of the company have surged 74.8% in the past year compared with the industry’s 22.3% rise.
DVA’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 35.57%. In the last reported quarter, it delivered an average earnings surprise of 22.22%.