FDA approves breakthrough cancer gene test


FDA approved a new cancer biomarker test that can detect genetic mutations in 324 genes and 2 genomic signatures in tumors.

FDA approved a new cancer biomarker test that can detect genetic mutations in 324 genes and 2 genomic signatures in tumors.

Simultaneously, CMSproposed coverage of the FoundationOne CDx (F1CDx) test (Foundation Medicine) a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test.

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The F1CDx detects gene mutations that may be found in any solid tumor and this information can be used by physicians according to professional guidelines to manage cancer patients, according to a statement from FDA.

“Moreover, it can 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,” FDA said. “Importantly, the F1CDx can detect genetic mutations that are indicated for multiple FDA-approved treatments, which extends beyond the previous ‘one test for one drug’ model.”

The test is the second IVD to be approved and covered after overlapping review by FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.

“By leveraging two policy efforts aimed at expediting access to promising new technologies, we’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA. “The FDA’s Breakthrough Device Program and Parallel Review with CMS allowed the sponsor to win approval for this novel diagnostic and secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application.”

Compared to other companion diagnostics previously approved by FDA, which match one test to one drug, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer.

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In addition, based on individual test results, the new diagnostic can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and healthcare professionals access to all the information in one test report, avoiding duplicative biopsies, FDA said.

“The F1CDx can help cancer patients and their health care 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, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in the statement. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.” 

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CMS also issued a proposed national coverage determination of the F1CDx and other similar NGS IVDs for Medicare beneficiaries with advanced cancer (such as recurrent, metastatic or advanced stage IV cancer), who have not been previously tested using the same NGS technology and continue to seek further cancer therapy.

The device works by sequencing DNA from a patient’s tumor sample to determine the presence of gene mutations and alterations. It also detects certain molecular changes (microsatellite instability and tumor mutation burden).

Results from comparing FICDx to companion tests indicated that the test’s ability to detect select mutation types representative of the entire 324 gene panel is accurate approximately 94.6% of the time.

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