The whole-genome sequencing assay is now available for breast, colorectal, and renal cancers following new clinical study results.
Myriad Genetics expanded the availability of its Precise MRD test to include patients undergoing treatment and surveillance for breast, colorectal, and renal cancers. The expansion increases access to the assay for the more than 6 million individuals in the US living with these types of cancer.
Precise MRD is a whole-genome sequencing-based assay that tracks up to 1,000 variants to create a personalized panel for each patient. The test is designed to provide clinicians with a quantitative molecular view of disease status across the cancer care continuum, including neoadjuvant therapy, post-surgical assessment, and long-term surveillance. The assay uses an ultrasensitive design to detect circulating tumor DNA (ctDNA) even in tumors with low levels of shedding.
“Expanding Precise MRD into breast, colorectal, and renal cancers marks a significant step forward in our broader precision oncology strategy,” says Brian Donnelly, chief commercial officer, Myriad Genetics, in a release. “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.”
Clinical Evidence from MONITOR-Breast Study
The company also announced results from the MONITOR-Breast study, which were published in Future Oncology. The prospective, multi-center study supported the clinical validity of the assay in breast cancer by demonstrating that ctDNA monitoring during neoadjuvant therapy provided real-time insight into treatment response and helped identify patients at risk for residual disease.
The study evaluated 154 patients with Stage I–III breast cancer across all molecular subtypes. Investigators analyzed 949 plasma samples collected longitudinally throughout treatment to assess ctDNA status.
“MONITOR-Breast highlights the strength of a whole-genome, tumor-informed approach to MRD detection,” says Dale Muzzey, chief scientific officer, Myriad Genetics, in a release. “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.”
Monitoring Across the Cancer Continuum
The assay is intended for use at multiple points in patient care to identify residual disease, provide prognostic information for risk stratification, track therapy response, and monitor for early signs of recurrence. The test is built to integrate into existing oncology workflows in both academic and community settings.
By utilizing whole-genome sequencing of tumor tissue, the test measures ctDNA at ultrasensitive levels while minimizing false positives. The company indicates that as it continues to expand across tumor types and build clinical evidence, the assay will play an increasing role in managing cancer care.
