New Large-Scale Meta-Analysis Demonstrates Strong Prognostic Performance of Myriad’s Prolaris® Biopsy Test in Localized Prostate Cancer
Findings from 14 studies involving more than 8,000 patients show Prolaris adds insight beyond conventional clinical risk categories
SALT LAKE CITY, July 02, 2026 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announces newly published data from the largest individual-patient-data meta-analysis of Prolaris to date, showing the Prolaris Biopsy Test adds significant prognostic information beyond conventional clinical risk categories for patients with localized prostate cancer. This evidence supports the role of the Prolaris Biopsy Test in localized prostate cancer risk stratification to help inform initial prostate cancer management discussions and shared decision-making. By providing additional insight into a patient’s risk of disease progression, Prolaris may help clinicians identify patients who could be appropriate for active surveillance versus those who may require treatment, as well as those who could be appropriate candidates for treatment escalation.
The study, Robust Meta-Analysis of a Clinical Cell-Cycle Risk (CCR) Score Demonstrates Broadly Applicable Metastasis and Disease-Specific Mortality Risk Stratification in Men With Localized Prostate Cancer, was published in Clinical Genitourinary Cancer. The analysis pooled data across 14 studies involving 8,478 patients, with individual participant data available for 7,924 patients. Results showed that the Prolaris combined clinical risk score (CCR) was significantly prognostic for the clinically meaningful outcomes of distant metastasis and prostate cancer-specific mortality, across all National Comprehensive Cancer Network® (NCCN®) risk groups and across initial disease management strategies. These analyses provide further evidence that Prolaris offers independent, additive prognostic information beyond established clinical tools -- including Gleason score, CAPRA score, and NCCN risk group -- and enables personalized risk discrimination for metastasis and prostate cancer-specific mortality in patients with prostate cancer.
The Prolaris Biopsy Test analyzes gene expression from a prostate biopsy sample and incorporates clinical information to generate a CCR score. The score is intended to support conversations and decisions related to initial prostate cancer management options, including active surveillance, definitive therapy, and multi-modal escalation.
“Our study shows that this tissue-based RNA test built on an array of cell cycle genes can provide prognostic information beyond clinical features alone, like CAPRA or NCCN, in localized prostate cancer,” said Steven Monda, MD, study author, urologist, and Clinical Instructor at the University of Michigan Health. “Further, CCR is prognostic for prostate cancer-specific mortality, even in low-risk patients. That’s useful in active surveillance conversations, where you want additional information about a patient’s individual cancer risk to inform counseling and surveillance intensity.”
Robust Evidence for Prolaris Across Risk Groups and Management Strategies
Using individual participant data where available, researchers evaluated Prolaris performance spanning NCCN risk groups and prostate cancer management strategies, with clinically meaningful endpoints and a consistent statistical approach. The results demonstrate that Prolaris is a robust prognostic tool with broad applicability for patients with localized prostate cancer. To learn more about the Prolaris Biopsy Test and its recently launched AI digital pathology features, clinicians and patients can visit myriad.com/prolaris.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic and precision medicine company committed to advancing health and well-being for all. Myriad Genetics develops and commercializes molecular tests that help patients and providers uncover genetic insights. Our tests assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care, support earlier detection, enable more precise treatment and contribute to lowering healthcare costs. For more information, visit www.myriad.com.
Myriad Genetics Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected role, intended use, and potential clinical utility of the Prolaris Biopsy Test. 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 24, 2026, 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.
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