FDA, CMS: Second Parallel Review Decision Ever for NGS Test

Regulatory NewsRegulatory News | 01 December 2017 |  By 

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cancer test in 2014.

Under the parallel review program, device makers can request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between a marketing decision by FDA and a national coverage determination by CMS.

The test, which can detect 324 genetic mutations and two genomic signatures in solid tumors, is also the first approved under FDA's new breakthrough devices program. FDA said the test can help identify patients with five specific tumor types and could benefit from 15 targeted therapies already approved by the agency.

"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," FDA Commissioner Scott Gottlieb said.

Future of the Parallel Review Program

In October 2016, FDA and CMS announced they would continue the parallel review program indefinitely, despite having only reached a parallel decision on a single product at the time.

An FDA spokesperson told Focus that FDA has received approximately 60 inquiries from device makers about the parallel review program and received 26 applications to participate.

At the MedTech Conference in September, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said FDA was looking to work with CMS to better leverage the use of real world data in reimbursement decisions, and CMS said the goal was to make parallel reviews the norm rather than the exception.

But CMS also said that staffing was a potential hurdle to the program, as FDA has a lot more employees to work on the applications.



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