Foundation Medicine Companion Dx Test Gets FDA OK for Use with Merck's Tepmetko in Lung Cance

Original from: 360dx

Roche subsidiary Foundation Medicine said on Monday that its FoundationOne Liquid CDx assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Merck KGaA's Tepmetko (tepotinib) in patients with non-small cell lung cancer.

Tepmetko received FDA approval earlier this year for the treatment of adult patients with metastatic NSCLC who have mesenchymal-epithelial transition exon 14 skipping alterations (METex14).

"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," Foundation Medicine Chief Medical Officer Mia Levy said in a statement. "We're proud that our liquid biopsy is the first companion diagnostic approved in the US for Tepmetko as it will help identify more patients with METex14 skipping alterations who may be appropriate for targeted treatment."

FoundationOne Liquid CDx uses next-generation sequencing to analyze 324 genes from circulating cell-free DNA isolated from plasma. It is FDA-approved to report short variants in more than 300 genes.

Source: Foundation Medicine Companion Dx Test Gets FDA OK for Use with Merck's Tepmetko in Lung Cance