Molecular information firm Foundation Medicine has secured approval from the US Food and Drug Administration (FDA) for its comprehensive companion diagnostic test, FoundationOne CDx, for solid tumours.
The genomic profiling (CGP) test is designed to identify people who could benefit from 17 select FDA-approved targeted treatments and to aid physicians in detecting potential candidates for clinical trials.
With genomic biomarkers such as microsatellite instability (MSI) and tumour mutational burden (TMB), the test would also predict the use of additional targeted oncology therapies.
FoundationOne CDx is intended to guide treatment decision by evaluating any class of genomic alterations in 324 genes that are considered to be involved in cancer growth.
The test is indicated as a companion diagnostic for non-small cell lung cancer (NSCLC), melanoma, colorectal, ovarian, or breast cancer.
Foundation Medicine CEO Troy Cox said: “Physicians will have an FDA-approved test for all solid tumours in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation.
“Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalised oncology care.”
Upon assessment, the test had demonstrated the ability to identify alterations matched to FDA-approved therapies, other alterations in genes involved with cancer growth, supply information on genomic biomarkers and relevant clinical trials.
The test is reported to include interpretive content developed for patients with any solid tumour type.
In line with the FDA approval, FoundationOne CDx has received preliminary National Coverage Determination (NCD) issued by the Centres for Medicare and Medicaid Services (CMS).