The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients.
The assay looks for genomic changes in 324 genes that are known to promote cancer growth. The FDA also approved FoundationOne CDx as a broad companion diagnostic for patients with non-small cell lung cancer, melanoma, colorectal cancer, breast cancer or ovarian cancer to help find the patients who could benefit from treatment with one of 17 on-label targeted therapies.
Foundation Medicine’s test also reports genomic biomarkers like tumor mutational burden, the company touted, which can inform clinical trials or help doctors choose targeted oncology therapies for their patients.
“Now that FoundationOne CDx is widely available in the U.S., oncologists can begin using this valuable test to help guide and simplify personalized treatment decisions for their patients,” Dr. Vincent Miller, chief medical officer at Foundation Medicine, said in prepared remarks. “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.”