Foundation Medicine has reached a regulatory milestone, reporting 100 approved companion diagnostic indications across the United States and Japan for its next-generation sequencing platforms FoundationOne CDx and FoundationOne Liquid CDx. The most recent approval was granted by Japan’s Ministry of Health, Labour and Welfare for use of FoundationOne CDx in identifying patients with NTRK fusion-positive solid tumors eligible for targeted therapy.
According to the company, the approvals include 57 indications in the United States and 43 in Japan, making Foundation Medicine the first provider of next-generation sequencing based companion diagnostics to reach this level of regulatory clearance across both markets.
Companion diagnostics are assays used to identify patient populations most likely to benefit from specific therapeutic agents. These tests undergo independent regulatory review and analytical and clinical validation to ensure reliability and consistency in clinical use. In oncology, they are increasingly integrated into treatment selection workflows for targeted therapies and immuno-oncology agents.
Foundation Medicine paved the way for high-quality, accessible genomic testing by being the first to undergo parallel review by the Food and Drug Administration (FDA) and Centers for Medicare and Medicare (CMS), resulting in FDA approval of FoundationOne CDx as a pan-tumor companion diagnostic and a landmark national Medicare coverage determination. Since then, Foundation Medicine has continued to help usher in a new wave of precision medicine in cancer care. With 100 approved companion diagnostic indications, healthcare providers can confidently trust our high-quality and clinically actionable comprehensive genomic profiling tests. We are focused on making a meaningful difference in the lives of patients with cancer, allowing them to be matched to the most effective treatment based on the unique make-up of their cancer’s DNA.
Dan Malarek, chief executive officer at Foundation Medicine
Foundation Medicine noted that its initial regulatory pathway included parallel review by the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services, culminating in FDA approval of FoundationOne CDx as a pan-tumor companion diagnostic and associated national Medicare coverage. Subsequent collaborations with biopharmaceutical manufacturers have supported regulatory approvals for more than 35 therapeutic products linked to companion diagnostic indications.
The company reports having issued over 1.5 million comprehensive genomic profiling results to date, reflecting clinical adoption of its tissue-based and liquid biopsy platforms in routine oncology practice.
The FoundationOne CDx assay uses DNA isolated from formalin-fixed, paraffin-embedded tumor tissue to assess genomic alterations across more than 300 cancer-associated genes, including short variants, copy number alterations, selected rearrangements, microsatellite instability status, and tumor mutational burden. FoundationOne Liquid CDx applies a similar gene panel to circulating cell-free DNA obtained from plasma samples, providing a non-invasive option for genomic profiling in patients with advanced malignancies. Both tests are authorized for prescription use as companion diagnostics linked to specific therapies listed within their approved labeling, while also supporting broader mutation profiling for clinical decision-making.
Regulatory labeling for both assays notes that testing does not guarantee assignment to an effective therapy, negative results do not exclude the presence of actionable alterations, and tissue-based testing may be required when liquid biopsy findings are negative or inconclusive.