New tissue-naïve monitoring test offers research insights into treatment response and resistance using only a blood sample

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.

By quantifying ctDNA tumor fraction at each timepoint, the test offers molecular response insights to complement standard imaging in early-phase clinical research.¹ The test also has capabilities for assessing resistance to therapy across more than 300 genes. FoundationOne Monitor expands Foundation Medicine’s monitoring portfolio, providing therapy developers with an additional option for use when studying treatment response, particularly when there is no tumor tissue available for testing.

Foundation Medicine’s monitoring portfolio also includes FoundationOne®Tracker, a tissue-informed ctDNA test, which launched for research use in June 2021 and investigational use in January 2023. FoundationOne Tracker is a precise tool for treatment response monitoring to inform personalized treatment strategies when tumor tissue is available. The test is also now accessible through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023.

“The addition of FoundationOne Monitor to our monitoring portfolio makes Foundation Medicine a one-stop shop for our biopharma partners’ treatment response monitoring research needs,” says Jason Adams, Vice President, Biopharma Enterprise Partnerships at Foundation Medicine. “When tissue is not available, FoundationOne Monitor offers comprehensive insights on treatment response to help our biopharma partners study individual variants, identify resistance mechanisms, and quantify ctDNA tumor fraction.”

FoundationOne Monitor is currently in development for clinical use.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

¹Araujo DV, Bratman SV, Siu LL. Designing circulating tumor DNA-based interventional clinical trials in oncology. Genome Med. 2019 Apr 19;11(1):22. doi: 10.1186/s13073-019-0634-x. PMID: 31003596; PMCID: PMC6474042.

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