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