FDA approves, CMS proposes coverage for extensive cancer genomic test

The U.S. Food and Drug Administration (FDA) has approved a new cancer screening test, and the Centers for Medicare & Medicaid Services at the same time proposed to cover its costs to beneficiaries.

The FoundationOne CDx (F1CDx) is a next generation sequencing (NGS)-based test that can provide information on genetic mutations that may help patients with cancer. Based on individual test results, F1CDx can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options.

The diagnostic test, developed by Foundation Medicine, Inc., can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type with about 94.6 percent accuracy. All this information is delivered in one test report, thereby avoiding the need for multiple biopsies. F1CDx differs from previously approved companion diagnostics that matched one test to one drug.

“The F1CDx can help cancer patients and their healthcare professionals make more informed care decisions without the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) in a press release. “With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options.” 

The test works by sequencing DNA from a patient’s tumor sample to determine the presence of gene mutations and alterations. It can also be used as a companion diagnostic to identify patients with specific mutations who may benefit from certain FDA-approved treatments for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer.

CMS issued a proposed national coverage determination of the F1CDx and other similar genomic sequencing tests for Medicare beneficiaries with advanced cancer (i.e., recurrent, metastatic or advanced stage IV cancer), who have not been previously tested with the technology and seek further cancer therapy. The proposed national coverage determination is intended to help patients and their treating physicians make informed cancer treatment decisions to improve health outcomes. Use of a test as a diagnostic also includes the ability to help patients and their treating physicians determine candidacy for cancer clinical trials.

Topics: Clinical , Medicare/Medicaid