Foundation Medicine has received the US Food and Drug Administration (FDA) approval for the use of FoundationOne Liquid CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with advanced breast cancer.
The test is now approved for use in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, part of the Roche group.
This combination targets adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, following recurrence after adjuvant endocrine therapy.
Foundation Medicine, a unit of Roche, is said to be the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests.
Using a routine blood sample, FoundationOne Liquid CDx analyses over 300 cancer-related genes to deliver genomic insights.
With this latest approval, US-based Foundation Medicine now holds seven companion diagnostic indications for breast cancer.
Foundation Medicine chief medical officer Mia Levy said: “This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first line setting for metastatic breast cancer patients.
“Our high-quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen.”
FoundationOne Liquid CDx is a qualitative next-generation sequencing in vitro diagnostic test designed for prescription use.
It utilises advanced hybridisation-based capture technology to analyse genes from circulating cell-free DNA (cfDNA) extracted from the plasma of anticoagulated peripheral blood in advanced cancer patients.
The test is FDA-approved to report short variants in over 300 genes and serves as a companion diagnostic to identify patients who may benefit from specific therapies based on approved product labelling.
Last month, the American health agency approved FoundationOne CDx and FoundationOne Liquid CDx as Companion Diagnostics for Lynparza (olaparib) in prostate cancer testing.
