Nov. 21, 2024—Foundation Medicine announced it has received approval from the FDA for FoundationOne Liquid CDx to be used as a companion diagnostic for tepotinib (Tepmetko, EMD Serono). Tepmetko received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.
“Access to a high-quality liquid biopsy, like FoundationOne Liquid CDx, can help unlock the power of precision medicine for more patients with non-small cell lung cancer,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a press statement. “We’re proud that our liquid biopsy is the first companion diagnostic approved in the U.S. for Tepmetko as it will help identify more patients with METex14 skipping alterations who may be appropriate for targeted treatment.”
FoundationOne Liquid CDx is a qualitative next-generation-sequencing–based in vitro diagnostic test for prescription use only that uses targeted high-throughput hybridization-based capture technology to analyze 324 genes using circulating cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer. With this approval, the company has more than 19 FDA-approved companion diagnostic indications for NSCLC.