Foundation Medicine has received approval from the US Food and Drug Administration (FDA) for its FoundationOne Liquid CDx test as a companion diagnostic (CDx) for Pfizer’s BRAFTOVI (encorafenib) in combination with cetuximab to detect metastatic colorectal cancer (mCRC).
FoundationOne Liquid CDx is a qualitative next-generation sequencing-based in vitro diagnostic test for advanced cancer patients with solid tumours.
Colorectal Cancer Alliance CEO Michael Salienza said: “As the second leading cause of cancer-related deaths for men and women combined, colorectal cancer has had a devastating impact on so many people.
“We’re encouraged by the ongoing progress happening in colorectal cancer care, and believe this approval is an important milestone in delivering broader access to more treatment options.”
BRAFTOVI in combination with Cetuximab was approved by the FDA in 2020 for the treatment of adult patients with previously treated mCRC with a BRAF V600E alteration.
FoundationOne Liquid CDx is now said to be the only FDA-approved comprehensive genomic profiling (CGP) test to identify patients with BRAF V600E alterations in mCRC who are eligible for treatment with the BRAFTOVI combination.
The test can analyse more than 300 cancer-related genes to provide genomic insights from a simple blood sample. It has also gained FDA approval for several CDx indications in breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer, and a pan tumour indication specific to NTRK1/2/3 fusions.
Foundation Medicine chief medical officer 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.”
FoundationOne Liquid CDx is currently for prescription use only. It analyses 324 genes using circulating cell-free deoxyribonucleic acid (DNA).
Foundation Medicine said that the test is also FDA-approved to report short variants in 311 genes and as a CDx to find patients who may benefit from treatment with specific therapies.
