Myriad Genetics expands Precise MRD test to three cancer types
Myriad Genetics, Inc. has expanded the availability of its Precise MRD test to include breast, colorectal and renal cancers, potentially reaching over 6 million individuals in the U.S. The test utilizes whole-genome sequencing to track up to 1,000 variants, providing dynamic disease monitoring. Clinical validity is supported by the MONITOR-Breast study, which demonstrated high detection rates and risk stratification capabilities.

*this image is generated using AI for illustrative purposes only.
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:
| Metric | Finding |
|---|---|
| Baseline detection rate | 93% of patients (including 20% at ultrasensitive levels below 100 PPM) |
| Prediction of pCR specificity | 100% |
| Post-NAT ctDNA positivity likelihood | 47 times more likely to remain positive after surgery |
| Sustained clearance | 78% of patients, significantly more likely to achieve pCR |
| Persistent or intermittent positivity | 22% of patients, identifying elevated risk |
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.
How will the expansion into breast, colorectal, and renal cancers impact Myriad Genetics' market share in the competitive ctDNA testing landscape?
What are the potential reimbursement challenges for Precise MRD given its longitudinal testing model across multiple cancer types?
Could the ultrasensitive detection capabilities of Precise MRD lead to earlier regulatory approvals for adjuvant therapies based on minimal residual disease status?
























