Foundation Medicine Reaches Historic 100 Companion Diagnostic Approvals Milestone
Key Insights
Foundation Medicine becomes the first and only company to achieve 100 approved companion diagnostic indications for next-generation sequencing in the United States and Japan.
The milestone includes 57 approvals in the United States and 43 approvals in Japan across FoundationOne CDx (search) and FoundationOne Liquid CDx (search) platforms.
The company has delivered over 1.5 million patient comprehensive genomic profiling reports and helped bring over 35 medicines to patients through approved companion diagnostic indications.
Foundation Medicine has achieved an unprecedented milestone in precision medicine by becoming the first and only company to reach 100 approved companion diagnostic indications for next-generation sequencing in the United States and Japan. The Boston-based precision medicine company announced this historic achievement following its recent Ministry of Health, Labour and Welfare (MHLW) approval of FoundationOne CDx (search) for a targeted therapy in NTRK fusion-positive solid tumors (search).
The milestone encompasses 57 approvals in the United States and 43 approvals in Japan across Foundation Medicine's FoundationOne CDx (search) and FoundationOne Liquid CDx (search) platforms. This achievement solidifies the company's position as the global leader in companion diagnostic approvals, with more approved companion diagnostic indications for next-generation sequencing than any other company in these key markets.
Advancing Precision Cancer Care
Companion diagnostics represent the gold standard in personalized cancer (search) care, undergoing extensive testing and review by independent regulatory agencies to ensure high-quality results. These tests are designed to accurately identify patients most likely to benefit from approved therapies, providing healthcare providers with critical information needed to direct personalized cancer treatment decisions.
"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 (search) as a pan-tumor companion diagnostic and a landmark national Medicare coverage determination," said Dan Malarek, chief executive officer at Foundation Medicine.
Clinical Impact and Industry Partnerships
The 100 companion diagnostic milestone translates directly to patient impact, with Foundation Medicine having delivered over 1.5 million patient comprehensive genomic profiling reports. The company has worked with biopharmaceutical companies to help bring over 35 medicines to more patients through its approved companion diagnostic indications.
Malarek emphasized the clinical significance of this achievement: "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 (search), allowing them to be matched to the most effective treatment based on the unique make-up of their cancer's DNA."
Comprehensive Genomic Testing Portfolio
Foundation Medicine's testing portfolio offers healthcare providers both tissue- and blood-based options for detecting genomic alterations that guide personalized treatment decisions. The FoundationOne CDx (search) test analyzes more than 300 cancer (search)-related genes for genomic alterations using tissue samples from a patient's tumor. Meanwhile, FoundationOne Liquid CDx (search) provides genomic insights by analyzing more than 300 cancer-related genes from a simple blood sample.
FoundationOne CDx (search) is a next-generation sequencing-based in vitro diagnostic device that detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with select gene rearrangements and genomic signatures including microsatellite instability (search) and tumor mutational burden (search). The test uses DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.
FoundationOne Liquid CDx (search) utilizes targeted high-throughput hybridization-based capture technology to analyze 324 genes using circulating cell-free DNA isolated from plasma derived from peripheral blood of advanced cancer (search) patients. The test is FDA-approved to report short variants in over 300 genes and serves as a companion diagnostic for specific therapeutic indications.
This milestone reinforces Foundation Medicine's commitment to transforming cancer (search) care through precision diagnostic solutions and strengthens confidence among biopharmaceutical partners seeking to accelerate innovation in personalized medicine.