The precision medicine company now has 57 approvals in the US and 43 in Japan for its FoundationOne CDx and FoundationOne Liquid CDx tests.
Foundation Medicine has achieved 100 approved companion diagnostic indications in the United States and Japan across its FoundationOne CDx and FoundationOne Liquid CDx next-generation sequencing-based platforms.
The Boston-based precision medicine company reached the milestone following recent Ministry of Health, Labour, and Welfare approval of FoundationOne CDx for a targeted therapy in NTRK fusion-positive solid tumors. Foundation Medicine now holds 57 approvals in the United States and 43 approvals in Japan.
“Foundation Medicine paved the way for high-quality, accessible genomic testing by being the only company to undergo parallel review by the Food and Drug Administration (FDA) and Centers for Medicare and Medicare, resulting in FDA approval of FoundationOne CDx as a pan-tumor companion diagnostic and a landmark national Medicare coverage determination,” says Dan Malarek, chief executive officer at Foundation Medicine, in a release.
Clinical Impact and Partnership Results
The milestone represents significant patient impact, with Foundation Medicine having delivered over 1.5 million patient genomic profiling reports. The company has collaborated with biopharmaceutical partners to help bring over 35 medicines to patients through its approved companion diagnostic indications.
Companion diagnostics serve as the gold standard in personalized cancer care, undergoing extensive testing and review by independent regulatory agencies. These tests help healthcare providers accurately match patients to therapies by identifying those most likely to benefit from approved treatments.
“With 100 approved companion diagnostic indications, healthcare providers can confidently trust our high-quality and clinically actionable genomic profiling tests,” says Malarek in a release. “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.”
Testing Platform Details
Foundation Medicine’s portfolio offers both tissue- and blood-based testing options for detecting genomic alterations that guide personalized treatment decisions. The FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations using tissue samples, while FoundationOne Liquid CDx provides genomic insights from blood samples by analyzing the same gene panel.
FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic device that detects substitutions, insertion, and deletion alterations, and copy number alterations in 324 genes, plus select gene rearrangements and genomic signatures, including microsatellite instability and tumor mutational burden using DNA from formalin-fixed, paraffin-embedded tumor tissue specimens.
FoundationOne Liquid CDx uses targeted high-throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients.
ID 182546437 © My Kids | Dreamstime.com
