The U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx™, the company’s comprehensive companion diagnostic test for solid tumours.

FoundationOne CDx is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors.

It is reported as the first and only FDA-approved test of its kind for all solid tumors, acting as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies including immunotherapies by assessing all classes of genomic alterations in 324 genes.

It can also be used as a tool for physicians that identifies patient opportunities for clinical trial participation; and an FDA-approved platform for diagnostic development for biopharma companies developing precision therapeutics.

Patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer may be identified, and benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications.

FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and, relevant clinical trial information.

It is estimated that approximately 1 in 3 patients across five common advanced cancers are expected to match with an FDA approved therapy.

Today, approximately 50% of new cancer drugs in development are projected to have a companion biomarker.

“Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option,” said Andrea Ferris, President and CEO of LUNGevity Foundation. “This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumour profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratise next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments.”

Source: BusinessWire