The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Pfizer’s Braftovi (encorafenib) in combination with cetuximab.
The combination therapy received approval from the FDA for previously treated metastatic colorectal cancer (mCRC) patients with a BRAF V600E alteration.
With the approval, FoundationOne Liquid CDx becomes the first comprehensive genomic profiling test to be approved by the FDA to detect patients with BRAF V600E mutations in mCRC who may benefit from treatment with the combination therapy.
Foundation Medicine chief medical officer Dr Mia Levy said: “Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients.
“This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this difficult-to-treat condition.”
The prescription-only FoundationOne Liquid CDx is a qualitative in vitro diagnostic test that leverages next-generation sequencing technology to identify cancer patients with advanced solid tumours.
This test holds the capability to assess more than 300 cancer-related genes from a simple blood sample, offering better genomic insights.
It uses circulating cell-free DNA to specifically analyse 324 genes.
Furthermore, the test obtained FDA approval to report short variants in 311 genes and to serve as a companion diagnostic to detect patients who may be qualified for treatment with specific therapies.
Last week, Foundation Medicine launched a new tissue-naive circulating tumour DNA (ctDNA) monitoring assay named FoundationOn Monitor.
This assay is intended for use in retrospective studies and offers research insights into treatment response and resistance using a blood sample.