FDA Wants to Further NGS, IVD Development to Foster Oncology Innovation

FDA Commissioner Scott Gottlieb elaborated on FDA initiatives aimed at developing next generation sequencing platforms and in vitro diagnostics to improve cancer treatment and research productivity and encourage innovation.

Speaking at the 2018 Community Oncology Conference in Oxon Hill, Maryland on Apr. 12, Gottlieb stressed the potential of NGS diagnostic technologies to target cancer with precision guided treatments and develop new treatments and highlighted the FDA’s efforts to keep pace with NGS technologies.

“We’re developing a policy approach…that give[s] patients and clinicians confidence in these panels’ analytical and clinical validity, while still allowing these sequencing systems to be efficiently updated as new genes, or gene variants, or improved algorithms come online,” he said.

He announced the release of two final guidances and one draft guidance on NGS and in vitro diagnostic development, stating the policies are designed to further the development of the platforms by allowing for more efficient regulatory review.

The first guidance discusses the FDA’s considerations for validating NGS-based tests designed to diagnose germline diseases, while the second describes the FDA’s thoughts on scientific evidence from accessible genetic variant databases being used to support clinical validity during premarket review.

A third draft guidance describes an optional streamlined submission process to determine the risks or non-risks of using investigational in vitro diagnostics in a clinical trial of investigational cancer drug or biological products.

“These new policies will improve the FDA’s ability to protect public health by ensuring these tests provide accurate and meaningful results, while at the same time speeding patient access to NGS assays by lowering barriers to innovation,” he said.

“The actions we’re taking today will encourage greater innovation and accelerate the adoption of tools that can increase the productivity of clinical research and improve the delivery of cancer care.” — James Miessler