Myriad Genetics Advances Ultrasensitive MRD Testing with March 2026 Clinical Launch
Key Insights
Myriad Genetics (search) will launch its Precise MRD (search) assay for limited clinical use in March 2026, starting with breast cancer (search) followed by colorectal and renal cancers later in the year.
The ultrasensitive test demonstrates exceptional performance with 93% baseline sensitivity in breast cancer (search) and 100% baseline detection in colorectal cancer (search) patients.
Clinical studies show the assay can detect circulating tumor DNA (search) at one part-per-million levels, enabling early prediction of treatment response and disease recurrence.
Myriad Genetics (search) announced a commercialization roadmap for its Precise MRD (search) (molecular residual disease) assay, marking a significant milestone in ultrasensitive circulating tumor DNA (search) detection. The company will transition the test from research-use-only to a limited clinical launch in March 2026, beginning with breast cancer (search) applications before expanding to colorectal and renal cancers later in the year.
The timeline reflects compelling clinical evidence demonstrating the assay's ability to detect ctDNA (search) at extremely low levels down to one part-per-million (ppm). "Our Precise MRD (search) program reflects Myriad's unwavering commitment to advancing precision oncology by bringing ultrasensitive MRD testing into real-world clinical care," said Sam Raha, President and CEO of Myriad Genetics (search).
Breakthrough Performance in Breast Cancer
The MONITOR-Breast study, a prospective multicenter observational trial evaluating patients with Stage I-III breast cancer (search) across all subtypes, demonstrated exceptional performance metrics for the Precise MRD (search) assay. The study systematically assessed ctDNA (search) using the tumor-informed whole-genome sequencing-based assay at frequent intervals during neoadjuvant therapy, with a median of 10 timepoints per patient.
Results presented at the 2025 San Antonio Breast Cancer (search) Symposium revealed 93% baseline sensitivity with high detection rates across stage, nodal status, and subtype. Notably, 21% of baseline samples and 73% of post-neoadjuvant therapy ctDNA (search) samples were detected at levels below 100 ppm, a range typically below the threshold of first-generation assays.
The study established critical clinical correlations: clearance of ctDNA (search) by day 50 of neoadjuvant therapy, followed by sustained ctDNA negativity, was significantly associated with pathological complete response. Conversely, ongoing or intermittent ctDNA positivity throughout the neoadjuvant period, even at ctDNA levels below 20 ppm, was significantly associated with residual disease.
Universal Detection in Colorectal Cancer
Collaborators from the National Cancer Center Hospital East in Japan reported interim outcomes from MONSTAR-SCREEN-3, a multi-center prospective study of patients with resectable Stage I-IV colorectal cancer (search) incorporating Precise MRD (search). The results, presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, demonstrated universal baseline ctDNA (search) detection across all patients, with 20% of samples identified at levels in the ultrasensitive range.
The assay achieved 100% sensitivity at one-month post-surgery in predicting recurrence. ctDNA (search) positivity at one-month post-surgery was associated with significantly shorter disease-free survival over a median follow-up of approximately six months (p<0.001). Patients with ctDNA levels above 100 ppm experienced significantly worse disease-free survival than those with lower level ctDNA detection, demonstrating the importance of ultrasensitive detection capabilities (p<0.001).
Technical Innovation and Future Expansion
Precise MRD (search) represents a tumor-informed circulating tumor DNA (search) assay designed to support longitudinal monitoring after cancer treatment. Using whole-genome sequencing to create a personalized assay for each patient, the test enables ultrasensitive detection of ctDNA (search) down to one part per million through custom selection of up to 1,000 targeted variants for deep analysis.
Myriad plans to expand into additional cancer types, including ovarian and endometrial cancers in 2027 and beyond. The growing body of evidence supporting Precise MRD (search) has been shared across multiple leading scientific forums, including publication in The Lancet Oncology and presentations at major oncology conferences.
Clinical Impact and Market Position
The limited clinical launch represents meaningful progress toward earlier insight, more informed decisions, and better outcomes for patients according to company leadership. The assay's ability to provide quantitative risk stratification and early treatment response prediction positions it as a significant advancement in precision oncology applications.
Dale Muzzey, Chief Scientific Officer at Myriad Genetics (search), emphasized the clinical significance: "Each study showcases the benefit of ultrasensitive and quantitative ctDNA (search) testing, as we observed noteworthy correspondence with clinical outcomes of interest."
The commercialization timeline positions Myriad to capture the growing molecular residual disease testing market, particularly for low-tumor-shedding cancers such as breast cancer (search) where ultrasensitive detection capabilities provide distinct clinical advantages.