FDA approves FoundationOne Liquid CDx as companion diagnostic for Exkivity

Original from: Medical Device Network

The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Takeda’s Exkivity (mobocertinib).

Exkivity already secured approval from the FDA for locally advanced or metastatic non-small cell lung cancer adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

FoundationOne Liquid CDx is claimed to be the only blood-based comprehensive genomic profiling test that received the US regulator’s approval for detecting EGFR exon 20 insertion mutations to identify suitable patients to treat with Exkivity.

This qualitative next-generation sequencing-based in vitro diagnostic test has the ability to analyse over 300 cancer-related genes for genomic alteration from a simple blood sample.

It specifically analyses 324 genes by deploying circulating cell-free DNA.

The prescription use-only test received FDA approval to report short variants in 311 genes, as well as a companion diagnostic to detect patients who are expected to benefit from treatment with specific therapies.

Foundation Medicine chief medical officer Mia Levy said: “Cancer is an incredibly complex disease, so it’s critical that oncologists leverage companion diagnostics, which are high-quality, well-validated genomic tests to inform treatment decisions for their patients.

“We’re proud of the work we’ve done with Takeda to develop blood and tissue-based companion diagnostics for therapies in their precision oncology pipeline, including this recent approval for Exkivity.”

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Source: FDA approves FoundationOne Liquid CDx as companion diagnostic for Exkivity