Myriad Genetics, Inc. has recently been granted a pivotal patent by the United States Patent and Trademark Office. This patent, numbered 11,932,910, and titled Combinatorial DNA Screening, solidifies the company’s capabilities in offering a sophisticated molecular residual disease (MRD) assay to the market. This groundbreaking patent covers the unique method developed by the company for preparing cell-free DNA.

The issuance of this patent signifies a significant milestone for Myriad Genetics. It underlines the company’s innovative proprietary technology, enhancing its position as a frontrunner in precision medicine. The patent bolsters the company’s Precise MRD offering and opens doors for potential licensing agreements in the MRD sector.

Examination of the News

Myriad Genetics’ patented method encapsulates a critical aspect of tumor-informed MRD assays. These assays detect circulating tumor DNA (ctDNA) through sequencing techniques. The patent focuses on how a sample can be optimally enriched with ctDNA for highly sensitive and specific detection. This patent, filed in 2016 during the nascent stages of MRD development, highlights the foresightedness of Myriad Genetics regarding the potential of tumor-derived cell-free DNA in cancer diagnostics.

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The Precise MRD assay leverages the company’s established technology, laboratory infrastructure, and intellectual property. It builds upon the success of MYGN’s FDA-approved MyChoice companion diagnostic and FirstGene platforms. According to a company spokesperson, these distinctive capabilities equip Myriad Genetics to effectively commercialize Precise MRD, thereby advancing oncology care in the evolving and underserved MRD market.

Strides in the Precise MRD Test

Myriad Genetics has made significant headway in enhancing its Precise MRD assay. The test is currently undergoing installation in a cutting-edge laboratory facility in Salt Lake City. It will soon undergo extensive validation to facilitate its utilization in various applications, including biopharma studies and interventional prospective trials.

Furthermore, the company has announced strategic research collaborations. These include a study on MRD efficacy in metastatic breast cancer with researchers at Memorial Sloan Kettering and an analysis of MRD utility in metastatic renal cell carcinoma with professionals at The University of Texas MD Anderson Cancer Center. Myriad Genetics is poised to present preliminary findings from retrospective MRD studies at upcoming conferences and expects complete results from the renal study later this year.

Myriad Genetics is on course to process samples for its biopharma partners by the fourth quarter of 2024. Sample submissions to MolDX (Molecular Diagnostic Services Program) are anticipated by year-end, aiming to secure coverage and reimbursement for molecular diagnostic tests. The commercial launch of Precise MRD is scheduled for the second half of 2025. The approach outlined in the granted patent is fundamental to the Precise MRD test, which has evolved since its initial filing.

Precise MRD is available for collaborative research studies between Myriad and academic or pharmaceutical researchers. The company envisions Precise MRD as a tool to monitor ctDNA levels throughout a cancer patient’s journey from diagnosis to survivorship. By aligning Precise MRD with the MyRisk hereditary cancer test and the recently acquired Precise Tumor and upcoming Precise Liquid tests, Myriad Genetics aims to offer a comprehensive suite of user-friendly clinical decision support tools for oncologists, further enhancing patient care.

Market Forecast

Research estimates indicate that the global MRD testing market was valued at $1.89 billion in 2022 and is projected to grow at a CAGR of 11.5% through 2030.

Recent Collaborations and Achievements

Last month, Myriad Genetics announced a collaboration with the National Cancer Center Hospital East in Japan. The research initiative aims to evaluate the prognostic and predictive value of MRD testing. The SCRUM-MONSTAR-SCREEN-3 study will employ Precise MRD to track ctDNA in patients with a diverse range of solid tumors and hematological cancers. This study intends to generate robust prospective clinical evidence, showcasing the broad applicability of MRD testing across cancer types and disease severities.

Stock Performance

Over the past six months, shares of MYGN have risen by 27.9%, outperforming the industry index, which rose by 1.8%.

Zacks Rank and Top Selections

Currently, Myriad Genetics holds a Zacks Rank #3 (Hold).

Within the broader medical sector, some notable stocks include Cardinal Health with symbol CAH, Stryker trading as SYK, and DaVita with symbol DVA. While Cardinal Health and Stryker are rated as Zacks Rank #2 (Buy), DaVita is currently designated as Zacks Rank #1 (Strong Buy). The complete list of today’s Zacks #1 Rank stocks can be found here.

Cardinal Health’s shares have surged by 54% over the past year. Earnings forecasts for Cardinal Health have been raised to $7.29 in fiscal 2024 and $8.04 in fiscal 2025, up from $7.28 and $8.02, respectively, in the last 30 days.

Cardinal Health has consistently surpassed earnings estimates in the past four quarters, delivering an average surprise of 15.6%. In the most recent quarter, the company exceeded expectations with a 16.67% earnings surprise.

Estimates for Stryker’s 2024 earnings per share have remained steady at $11.86 in the last 30 days. Stryker’s shares have risen by 26.3% in the past year, compared to the industry’s 5.2% increase.

Stryker has consistently outpaced earnings estimates in each of the previous four quarters, with an average surprise of 5.09%. In the most recent quarter, the company achieved an average earnings surprise of 5.81%.

Estimates for DaVita’s 2024 earnings per share have been revised upwards from $8.97 to $9.23 in the past 30 days. DaVita’s shares have surged by 74.8% over the last year, in contrast to the industry’s 22.3% rise.

DaVita has consistently surpassed earnings estimates in the last four quarters, with an average surprise of 35.57%. In the most recent quarter, the company recorded an average earnings surprise of 22.22%.

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