Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostic testing and precision medicine, today announced a commercialization roadmap for its Precise MRD™ (molecular residual disease) assay and highlighted compelling data that reinforces the clinical value of ultrasensitive circulating tumor DNA (ctDNA) detection across cancer types.

Myriad will launch Precise MRD with select community-based clinicians in March 2026 in breast, followed by colorectal and renal cancers later this year. The company may expand into additional cancer types, including ovarian and endometrial in 2027 and beyond.

"Our Precise MRD 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, Myriad Genetics. "By detecting ctDNA at extremely low levels and demonstrating a clear link to clinical outcomes, this limited clinical launch represents meaningful progress toward earlier insight, more informed decisions, and better outcomes for patients."

This timeline reflects the clinical evidence demonstrating Precise MRD's high sensitivity and ability to detect ctDNA down to one part-per-million (ppm). Interim study analyses have suggested near-universal baseline detection and recurrence prediction in colorectal cancer, as well as high baseline sensitivity in breast cancer.

The growing body of evidence behind Precise MRD and the increasing role of ultrasensitive MRD testing in clinical practice has been shared across multiple leading scientific and industry forums, including publication in The Lancet Oncology, presentations at the 2025 San Antonio Breast Cancer Symposium® (SABCS) and the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, and the introduction of Myriad's MRD strategy at the J.P. Morgan Healthcare Conference.

Study Findings

MONITOR-Breast is a prospective, multicenter observational study evaluating patients with Stage I-III breast cancer across all subtypes. The study systematically assessed ctDNA using Precise MRD, a tumor-informed whole-genome sequencing (WGS)-based assay, at frequent intervals during neoadjuvant therapy, with a median of 10 timepoints per patient. This design enabled a high-resolution, longitudinal analysis of ctDNA dynamics across the neoadjuvant treatment course. Results shared at SABCS demonstrated:

• High baseline sensitivity: 93% baseline sensitivity, with high detection rates across stage, nodal status, or subtype.
• Ultrasensitive detection: 21% of baseline samples and 73% of post-neoadjuvant therapy ctDNA samples were detected at levels below 100 ppm, a range typically below the threshold of first-generation assays.
• Early clearance predicts response: Clearance of ctDNA by day 50 of neoadjuvant therapy, followed by sustained ctDNA negativity, was significantly associated with pathological complete response.
• Persistent ctDNA positivity predicts residual disease: Ongoing or intermittent ctDNA positivity throughout the neoadjuvant period, even at ctDNA levels below 20 ppm, was significantly associated with residual disease.

At ASCO® GI, collaborators from the National Cancer Center Hospital East in Japan reported interim key outcomes from MONSTAR-SCREEN-3, a multi-center, prospective study of patients with resectable Stage I-IV colorectal cancer that incorporates Precise MRD:

• Universal baseline detection: 100% baseline ctDNA detection across all patients with 20% of samples identified at levels in the ultrasensitive range.
• High sensitivity for recurrence prediction: 100% sensitivity at one-month post-surgery in predicting recurrence.
• Postoperative prognostic significance: ctDNA 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).
• Quantitative risk stratification: Patients with ctDNA levels above 100 ppm experienced significantly worse disease-free survival than those with lower level ctDNA detection, demonstrating the importance of an ultra sensitive assay (p<0.001).