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FDA Continues Embrace of Precision Medicine with Tumor Test Approval


In addition to the approval, the agency announced that it is streamlining the review process for NGS tumor tests.

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The FDA today authorized marketing of a new next-generation sequencing (NGS) tumor test and simultaneously announced that it is making changes to speed up future reviews and approvals for such tools.

The newly approved test was developed by Memorial Sloan Kettering Cancer Center. Called the Integrated Mutation Profiling of Actionable Cancer Targets, or IMPACT, it is an in vitro assay made to better inform treatment decisions.

While many diagnostics are designed to detect a specific biomarker to be targeted by a single drug, IMPACT can rapidly identify mutations in over 450 distinct genes by comparing a patient’s tumor cells to their normal tissue. The FDA’s review found the test to be “highly accurate” in identifying mutations across multiple cancer types, although its results “are not conclusive for choosing a corresponding treatment.”

The FDA said that today’s decision is part of a new policy framework for the review of NGS-based cancer profiling tools. In conjunction with the approval, it announced the creation of a new Class II regulatory pathway for the assays.

The agency also granted accreditation to the New York State Department of Health (NYSDOH) as a third-party reviewer of in vitro diagnostics. NYSDOH previously reviewed and approved IMPACT for use on samples from patients in the state of New York. Third-party review has been touted as a key apparatus in the regulator’s overall effort to update its review processes.

"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,” Commissioner Scott Gottlieb, MD, said in a statement. “As this field advances, we are modernizing the FDA's approach to the efficient authorization of laboratory tests.”

Since Gottlieb assumed the role, he has consistently emphasized those reform efforts through statements and actions. Precision medicine has been a major focus area. The agency has approved the first ever CAR-T treatments for cancer patients in recent months, and last week it announced it was easing its stance on direct-to-consumer genetic testing.

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