FDA Reports Progress in Advancing Regulatory Science for Diagnostics

The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and Innovation Act, says the agency has made “significant progress” in advancing the science of medical product development and evaluation, improving clinical evaluation, ensuring the safety and effectiveness of marketed products, and infrastructure/ organizational development to advance regulatory science.

“FDA’s regulatory responsibility to evaluate medical products drives our research agenda, but the outcomes of this research also directly foster and stimulate new medical product development,” writes the agency in the report.

Improving Evaluation
The agency reports it has refined predictive models to support product evaluation by developing computational tools that now support nonclinical evaluation of medical products.

Importantly for the diagnostic industry, the FDA says it has carefully designed a pathway to foster biomarker development and adoption. Over this review period, the FDA reports it qualified three new biomarkers for use in clinical trials through the Biomarker Qualification Program.

Advancing Health Promotion
The FDA supported the regulatory public health response to the threats of Ebola virus and Zika virus through development of tools, reference materials, and publication of guidance to support rapid development of new medical products to diagnose, treat, and prevent spread of these diseases.

Infrastructure Development
Over the past two years, the agency says it enhanced information technology tools that support scientific review of regulatory applications for complex, molecular diagnostics. To make possible the secure deposition, retrieval, and analysis of the vast data needed to support next-generation sequencing-based testing, the FDA continued to enhance its high-performance, scientific computing environments.

Additionally, the FDA says it has expanded its ability to evaluate data from mass spectrometry for proteomics and glycomics.

Two other diagnostic-specific mentions in the report include the development of guidelines for reporting results of genetic tests in clinical pharmacology studies, as well as development of methods to analyze data from clinical validation studies for companion diagnostic assays.

Takeaway: Much of the progress the FDA notes in its recent report highlight how advances in diagnostic technology are driving advances regulatory science.