MONSTAR-SCREEN-3 study showed 100% detection of circulating tumor DNA (ctDNA) at baseline timepoint, and 60% of patients testing positive one month after surgery had tumor fractions only detectable via ultra-sensitive MRD

 Myriad Genetics, Inc, a leader in molecular diagnostic testing and precision medicine, announced new molecular residual disease clinical data from the MONSTAR-SCREEN 3 study, a collaboration with the National Cancer Center Hospital East (NCCHE) in Japan, demonstrating successful pan-cancer implementation of Myriad’s ultra-sensitive Precise MRD Test to detect and monitor ctDNA in patients.

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The interim results – first shared at the 2025 ASCO Annual Meeting by Tadayoshi Hashimoto, MD, PhD of the NCCHE – achieved 100% baseline detection of ctDNA across tumor types, including those traditionally challenging to assess because of low levels of ctDNA in blood. Key findings include:

  • Personalized whole-genome sequencing (WGS) panels utilizing up to 1,000 somatic variants were successfully created via Precise MRD for 97.3% of patients tested.
  • Precise MRD detected tumor fractions as low as 0.0001% (1 part per million) and showed a clinically meaningful lead time in detecting recurrence compared to imaging.
  • Clearance of ctDNA during neoadjuvant chemotherapy, as shown by Precise MRD, predicted pathological complete response.

“Previous studies have shown that ctDNA-based MRD detection significantly correlates with recurrence risk and predicts benefit of adjuvant chemotherapy in certain cancers,” said Takayuki Yoshino, MD, PhD of the NCCHE and principal investigator for the MONSTAR-SCREEN-3 study. “However, first-generation MRD assays appear to have limited sensitivity in low ctDNA-shedding tumors. For our pan-cancer study, we selected Precise MRD because of its enhanced sensitivity across diverse tumor types.”

“Our results showed that among samples that were ctDNA-positive at the one-month post-surgery timepoint, 60% had ctDNA levels in the ultra-sensitive range that may not have been reported as positive by first generation MRD tests,” said Dr. Hashimoto. “In addition, these patients had significantly worse disease-free survival compared to those that were ctDNA-negative, demonstrating the importance of ultra-sensitive ctDNA detection.”

“The initial results from the study highlight the tremendous potential for utilizing Precise MRD across cancer types to enhance personalized treatment and therapeutic strategies for patients,” said Dale Muzzey, PhD, chief scientific officer, Myriad Genetics. “Precise MRD is informed by WGS, enabling the tracking of thousands of tumor-specific sites, far more than what is possible with first-generation MRD tests. Tracking so many variants yields exceptional sensitivity even in cancers with low shedding tumors such as breast and renal. A key benefit of our ultrasensitive assay is confidence in ctDNA results, as shown by the finding that the ctDNA status after neoadjuvant treatment was strongly associated with pathological response.”

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About the Study

The SCRUM-MONSTAR-SCREEN-3 study explores how multi-omic profiling, including MRD, can be used to develop more personalized treatment and therapeutic strategies in three study cohorts. Approximately 1,200 patients across more than 20 cancer types are undergoing MRD monitoring via Precise MRD as part of the study. The goal of SCRUM-MONSTAR-SCREEN-3 is to generate high-quality, prospective, clinical evidence showing that MRD testing can be broadly applied across cancer types, including many that are “low-shedding,” and to patients with different stage of extent of disease. ctDNA levels are being assessed at diagnosis, post-neoadjuvant therapy, post-surgery, and every 3-6 months thereafter for ≥2 years.

About Myriad’s Precise MRD Test

Myriad’s Precise MRD test is a tumor-informed, WGS-based test that monitors hundreds to thousands of tumor-specific variants, enabling exceptional sensitivity and quantification of ctDNA in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment.

Precise MRD is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators. Myriad continues to develop its Precise MRD assay to meet the needs of patients with cancer, academic partners, and biopharma companies. The test is currently being evaluated in several high-impact studies and is performed at the company’s laboratory facility in Salt Lake City.

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Source – GlobeNewswire