FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

Regulatory NewsRegulatory News | 15 November 2017 |  By 

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of Health (NYSDOH) under its clinical laboratory evaluation program.

In conjunction with the announcement, FDA also laid out a new framework for clearing NGS-based tumor profiling tests based on recommendations from accredited third-party reviewers, the first of which is NYSDOH.

"The goal of allowing NGS-based tumor profiling tests to undergo review by accredited third-parties is to reduce the burden on test developers and streamline the regulatory assessment of these types of innovative products," FDA Commissioner Scott Gottlieb said.

FDA gained the authority to accredit third-party reviewers under the FDA Modernization Act to increase the efficiency of reviews for certain devices that require a 510(k). The agency currently lists seven third-party reviewers, including NYSDOH, that are accredited to review a wide range of Class I and Class II devices.

FDA also says it has classified the IMPACT test and other NGS-based tumor profiling tests as Class II devices and that laboratories that develop such tests will be able to submit applications to either FDA or NYSDOH.

"Moving forward, laboratories whose NGS-based tumor profiling tests have been approved by NYSDOH do not need to submit a separate 510(k) application," FDA said. Laboratories can instead forward their NYSDOH application and the state's review memorandum and recommendation to FDA to receive 510(k) clearance.

FDA reviewed the IMPACT test under its de novo pathway, through which sponsors can request the agency classify a low- to moderate-risk device that has no legally marketed predicate device as Class I or Class II.

For its review, FDA said it looked at information from MSK, including what was submitted previously to NYSDOH "to inform and expedite" its decision.


The IMPACT test works by comparing a patient's tumor to a normal tissue sample to look for mutations in 468 genes and other biomarkers linked to various forms of cancer.

FDA says the IMPACT test is "highly accurate" and can identify mutations in more genes than any other test it has reviewed in the past.

However, FDA says that while the results of the test can provide valuable insights to patients and physicians, its results alone "are not conclusive for choosing a corresponding treatment."

As such, the test's indications for use state that "the test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product."

FDA, Press Release


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