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FoundationOne®Monitor

"Foundation Medicine, Inc...announced that research from its robust oncology diagnostics portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California April 5-10, 2024....In a retrospective study of 58 patients from the Genentech, a member of the Roche Group, MyPathway study (NCT02091141)...Results suggest ​serial early ctDNA monitoring ​is a valuable complementary tool for real-time treatment response monitoring to targeted therapy....Leveraging plasma collected serially from patients in Genentech’s Prospective Clinico-Genomic (PCG) study (NCT04180176), the FoundationOne Monitor assay was used to investigate ctDNA tumor fraction for monitoring treatment response."

We describe a highly specific tumor naïve algorithmic filtration of non-tumor signal to enable high confidence ctDNA quantification and MR assessment. On tx MR is associated with favorable outcomes. These findings may enable personalized tx approaches tailored to a patient's risk of progression and downstream cancer morbidity.

Clinical Trial Registration Number: NCT03016312 Background: IMbassador250 (IM250) was a prospective phase III trial which showed no overall survival (OS) benefit for adding atezolizumab to enzalutamide for men with mCRPC who had prior progression on abiraterone. Here we report on a new tumor-naïve monitoring assay (F1M) for molecular response assessment which is based on ctDNA TF detection and dynamics. TF detection at C3D1 was linked to unfavorable outcomes and identified early progression post-abiraterone, with increased information derived from TF detection at baseline. TF on F1M thus complements PSA testing, which had a lower PPV for identifying early progression than ctDNA.

"Foundation Medicine, Inc., today announced the launch of its tissue-naïve circulating tumor DNA (ctDNA) monitoring assay, FoundationOne^®Monitor, for research use in retrospective studies. Currently available for biopharma customers, FoundationOne Monitor provides unique access to Foundation Medicine’s ctDNA tumor fraction biomarker that incorporates information to improve sensitivity and maintain high specificity to monitor ctDNA levels."