5:31 AM
Apr 12, 2018
 |  BC Extra  |  Politics & Policy

FDA streamlining cancer diagnostics development

Editor's Note: This article was updated on Apr 12, 2018 at 8:01 AM PDT

FDA Commissioner Scott Gottlieb Thursday announced new policies that are intended to encourage development of next-generation sequencing (NGS) technology for cancer diagnostics.

In a speech to the Community Oncology Alliance, Gottlieb presented the new guidance documents as part of broader policies that are intended to reduce the cost and improve the quality of cancer drug development. He emphasized the need to reduce drug costs and argued that lower development costs will help achieve this goal.

“Rising co-pays and co-insurance are pushing far too many patients into a financial no-man’s land where sometimes they must literally choose between exhausting their bank accounts, or going without access to potentially effective treatments,” Gottlieb said.

He added: “With a few notable exceptions, drug development costs are still soaring; too many trials still fail, often in late stages, not just because the science is challenging, but also because the clinical trial paradigm is badly in need of modernization.” Modern diagnostic tools like NGS can reduce the uncertainty, and the cost, of clinical trials, Gottlieb said.

The guidances announced Thursday are intended to integrate expertise from physicians and scientists into FDA reviews in ways that could make it possible to exempt some NGS tests from premarket review. They also include processes that will lead to a common regulatory approval filing for co-developed drugs and diagnostics.

“Taken together, these guidances pave the way for possible down-classification and even exemption from premarket review of NGS-based tests that demonstrate conformity with future FDA-recognized standards and tests that rely on demonstrating their validity against FDA-recognized databases,” Gottlieb said.

The new guidances include Considerations for Design, Development, and Analytical Validation of NGS-Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases. The guidance could lead to the development of consensus standards for NGS-based tests developed by the oncology community and recognized by FDA, Gottlieb said. It also lays the groundwork for FDA to classify NGS tests for germline diseases as moderate risk (class II) devices, which could make it possible for the agency to exempt them from premarket review.

Another guidance to be released Thursday covers the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics. It describes how FDA will approach the use of publicly accessible genetic variant databases, such as NIH’s ClinGen database, to support clinical validity during premarket review. Gottlieb said the guidance will “encourage expert-based crowd sourcing of NGS evidence generation, curating, and data sharing.”

The third guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, presents oncology drug trial sponsors an optional submission process to determine if use of an investigational in vitro diagnostic (IVD) is considered a significant or non-significant risk, or if it is exempt from review. “This is a step toward our goal of having a common filing for a drug and diagnostic system where the drug is co-developed with a diagnostic test,” Gottlieb said.

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