FDA grants breakthrough designation to FoundationOne Tracker, an assay for detecting MRD in cancer, aiding treatment decisions and relapse monitoring.

Foundation Medicine has received FDA breakthrough device designation for its FoundationOne Tracker, a circulating tumor DNA (ctDNA) detection and molecular monitoring assay. This tool is designed to detect molecular residual disease (MRD) in early-stage cancer after curative therapy, helping to guide subsequent treatment decisions and monitor the risk of relapse. The assay uses patient-specific algorithms and a personalized design for ctDNA detection in plasma, and has been developed in collaboration with Natera, combining their respective expertise in genomic profiling and ctDNA monitoring.

The FoundationOne Tracker not only aims to detect MRD in early-stage cancers but also to monitor ctDNA in advanced-stage cancers. It assesses patients’ response to therapy and tracks MRD and molecular residual relapse. The tool’s broader goal is to improve ctDNA detection and molecular monitoring across various cancer stages, enhancing the personalization of cancer treatment plans. Foundation Medicine’s CEO, Brian Alexander, emphasizes the company’s commitment to advancing precision cancer care by enabling oncologists and partners to make informed treatment decisions based on early ctDNA detection and monitoring therapy responses.

Foundation Medicine is actively involved in research to demonstrate the utility of MRD detection. Recent data presented at the ASCO Gastrointestinal Cancer Symposium showed the feasibility of using MRD in metastatic colorectal patients post-surgery. Additional MRD data is set to be presented at the ASCO Genitourinary Cancers Symposium, focusing on the genomics of resected early-stage bladder cancer. This research is part of the effort to validate the use of comprehensive genomic profiling-informed MRD detection in ctDNA, potentially leading to more precise and effective cancer management.

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