Foundation Medicine has commercially launched its comprehensive genomic profiling (CGP) assay, FoundationOne CDx, for all advanced solid tumours in the US.
Approved by the US Food and Drug Administration (FDA), the assay test is designed to examine genomic alterations in 324 genes that are associated with cancer growth.
The information obtained from the test can aid physicians in deciding which treatment course would be best for individual patients.
The FDA also approved the CGP assay as a broad companion diagnostic for some non-small cell lung cancer, melanoma, colorectal, ovarian and breast cancer forms.
This capability is intended to help in detecting patients who may respond to one of 17 on-label targeted treatments.
The platform also provides information of genomic biomarkers such as microsatellite instability (MSI) and tumour mutational burden (TMB) that indicate the use of other targeted oncology therapies and necessary clinical trial information.
Foundation Medicine chief medical officer Vincent Miller said: “Now that FoundationOne CDx is widely available in the US, oncologists can begin using this valuable test to help guide and simplify personalised treatment decisions for their patients.
“By integrating FoundationOne CDx early into routine clinical care, oncologists can create treatment efficiencies and expand access to biomarker-driven medicines for patients, with the potential to improve treatment outcomes.”
FoundationOne CDx is expected to guide personalised treatment decisions and at the same time minimise the duration and tissue required for biomarker testing.
Biopharma companies will now be able to use the platform for clinical research and development of companion diagnostics for precision therapeutics.