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FDA approves first breakthrough-designated test to detect extensive number of cancer biomarkers

CMS will cover the test to make the targeted therapy options available to all who need it.

Susan Morse, Managing Editor

The Centers for Medicare and Medicaid Services said it will cover the first breakthrough-designated test to detect cancer biomarkers.

The Food and Drug Administration on Thursday approved the FoundationOne CDx, or F1CDx, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. 

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The test is the second in vitro diagnostic test to be approved and covered after overlapping review by the FDA and CMS under the parallel review program, which facilitates earlier access to innovative medical technologies.

"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 healthcare costs," said FDA Commissioner Scott Gottlieb, MD. 

[Also: FDA's approval of lower-cost hepatitis C drug expands treatment options for Medicaid patients]

The program and parallel review with CMS secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application, Gottlieb said.

Compared to other companion diagnostics previously approved by the FDA that 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, CMS said. 

Additionally, 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 the information in one test report, avoiding duplicative biopsies.

"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, MD, director of the FDA's Center for Devices and Radiological Health. "With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options." 

Today, 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. 

Use of a test as a diagnostic also includes the ability to help patients and their treating physicians determine candidacy for cancer clinical trials.

Healthcare professionals have said it's tough to recruit patients for clinical trials.

"Through parallel review and collaboration, we speed access to innovative diagnostics, so that doctors are better able to deliver the best quality care to their patients and patients have access to these state-of-the-art tests," said Seema Verma, administrator of CMS.

Twitter: @SusanJMorse
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