Myriad Genetics, Inc. has announced results from the largest individual-patient-data meta-analysis of its Prolaris Biopsy Test to date, demonstrating significant prognostic value for patients with localized prostate cancer. The study, published in Clinical Genitourinary Cancer, pooled data across 14 studies involving 8,478 patients, with individual participant data available for 7,924 patients. The findings indicate that the Prolaris combined clinical risk score (CCR) provides independent, additive prognostic information beyond established clinical tools such as Gleason score, CAPRA score, and NCCN risk group.

The analysis evaluated Prolaris performance across all National Comprehensive Cancer Network (NCCN) risk groups and initial disease management strategies. Results showed the CCR score was significantly prognostic for distant metastasis and prostate cancer-specific mortality. This evidence supports the role of the Prolaris Biopsy Test in risk stratification to inform initial prostate cancer management discussions and shared decision-making.

Steven Monda, MD, study author and Clinical Instructor at the University of Michigan Health, emphasized the clinical utility of the test. "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," Monda said. He noted that CCR is prognostic for prostate cancer-specific mortality even in low-risk patients, which is useful for active surveillance conversations.

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 decisions related to initial prostate cancer management options, including active surveillance, definitive therapy, and multi-modal escalation. By providing additional insight into a patient’s risk of disease progression, the test aims to help clinicians identify patients appropriate for active surveillance versus those who may require treatment or treatment escalation.

Study Details

The meta-analysis utilized individual participant data where available, evaluating Prolaris performance with clinically meaningful endpoints and a consistent statistical approach. The study confirmed that Prolaris is a robust prognostic tool with broad applicability for patients with localized prostate cancer.

Myriad Genetics, Inc. has broadened access to its Precise MRD test for patients undergoing treatment and surveillance for breast, colorectal and renal cancers. This expansion makes the ultrasensitive, whole-genome sequencing-based assay available to more than 6 million individuals living with these cancers in the U.S., significantly increasing the potential patient population for the test.

Precise MRD generates a personalized panel for each patient by tracking up to 1,000 variants. The test provides clinicians with a dynamic and quantitative molecular view of disease status across the cancer care continuum, from neoadjuvant therapy through post-surgical assessment and long-term surveillance. Its design enables robust detection of circulating tumor DNA (ctDNA) even in low-shedding tumors.

MONITOR-Breast study results

The company announced the publication of results from the prospective, multi-center MONITOR-Breast study in Future Oncology, supporting the clinical validity of Precise MRD in breast cancer. The study evaluated 154 patients with Stage I–III breast cancer across all molecular subtypes, analyzing 949 plasma samples collected longitudinally throughout treatment.

Key findings from the study include:

The study demonstrated that ultrasensitive ctDNA monitoring during neoadjuvant therapy provided real-time insight into treatment response. Longitudinal testing identified 44% more patients at risk for residual disease than testing at the post-neoadjuvant therapy timepoint alone.

Strategic expansion

"Expanding Precise MRD into breast, colorectal and renal cancers marks a significant step forward in our broader precision oncology strategy," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. "In a single, easy-to-read report, Precise MRD delivers ultrasensitive ctDNA detection and longitudinal insights, along with the clinical interpretation support clinicians need to help guide treatment and surveillance decisions."

Dale Muzzey, Chief Scientific Officer, Myriad Genetics, highlighted the strength of the whole-genome, tumor-informed approach. "Precise MRD enables ultrasensitive ctDNA detection and longitudinal disease monitoring that captures dynamic treatment response," Muzzey said. "The ability to identify additional at-risk patients through frequent sampling, beyond a single timepoint assessment, demonstrates the importance of molecular monitoring in improving risk stratification and guiding clinical decision-making."

The test integrates into existing oncology workflows across academic and community settings. It is designed for use across key points in patient cancer care, including neoadjuvant monitoring, post-surgical assessment and surveillance.