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FDA Approves Foundation Medicine's Liquid Biopsy Test as CDx for Novartis' Tabrecta in NSCLC

NEW YORK – Foundation Medicine said on Thursday that the US Food and Drug Administration has approved the liquid biopsy next-generation sequencing test, FoundationOne Liquid CDx, for use as a companion diagnostic to identify patients eligible for treatment with capmatinib (Novartis' Tabrecta).

The blood-based NGS test will specifically identify metastatic NSCLC patients whose tumors have mutations resulting in MET exon 14 skipping. The FDA granted accelerated approval to capmatinib for this patient population in May 2020, at which time it simultaneously approved Foundation Medicine's tissue-based NGS assay, FoundationOne CDx, as a companion diagnostic. Accordingly, capmatinib now has two FDA-approved companion diagnostics.

Japanese regulators also followed suit and approved the agent — which is an option for both first-line therapy and for previously treated patients — for this indication in June 2020.

FoundationOne Liquid CDx, which is now approved as a companion diagnostic for nine therapies across four cancer types, is designed to detect mutations and alterations in over 300 genes. It is also capable of assessing patients' microsatellite instability, blood tumor mutational burden, and NTRK fusion status, though the FDA has not yet approved these additional uses.

According to Roche subsidiary Foundation Medicine, the additional approval for the liquid biopsy is a valuable option given its noninvasive nature.

"For lung cancer patients with METex14, having the option of a noninvasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need," Foundation Medicine's CEO Brian Alexander said in a statement. "This approval, coupled with last year's simultaneous therapy and companion diagnostic approval for [capmatinib] and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient."

The companion diagnostic approval for FoundationOne CDx and capmatinib is a result of Foundation Medicine's ongoing strategic collaboration with Novartis; to date, there are now four Novartis oncology products with designated Foundation Medicine companion diagnostics.