If you are interested in learning more about how FDA is modernizing its data strategy, including data quality, data stewardship, data exchange, and data analytics, attend the “Modernizing FDA’s Data Strategy” public meeting on March 27th!

Join the challenge to advance techniques for surveillance and detection of adverse events associated with FDA products. Submissions are being accepted until February 28th.

FDA’s technology modernization will be informed by direct engagement with stakeholders. As an example of stakeholder engagement, FDA has used PrecisionFDA to provide a community platform for the evaluation of next-generation sequence data and regulatory exploration.

The precisionFDA CDRH Biothreat Challenge addressed the need for a comprehensive citizen-science benchmarking study of infectious disease NGS diagnostic classification algorithms.

Stay up to date on the latest precisionFDA news and challenge information

PrecisionFDA and Georgetown-ICBI are launching the Brain Cancer Predictive Modeling and Biomarker Discovery Challenge! The goal of this challenge is to advance techniques for the prognosis and treatment of brain tumors by asking participants to develop machine learning and/or artificial intelligence models to identify biomarkers and predict patient outcomes using gene expression, DNA copy number, and clinical data.

Advancing the Regulatory Science of Omics via Crowdsourcing on the precisionFDA Platform

Breakout Session: Engaging the Global Community to Support and Inform Regulatory Science

Standardized benchmarking approaches are required to assess the accuracy of variants called from sequence data. Here, as part of the Global Alliance for Genomics and Health (GA4GH), we present a benchmarking framework for variant calling. We provide guidance on how to match variant calls with different representations, define standard performance metrics, and stratify performance by variant type and genome context. Our approach has been piloted in the PrecisionFDA variant-calling challenges to identify the best-in-class variant-calling methods within high-confidence regions. Finally, we recommend a set of best practices for using our tools and evaluating the results.

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

New in May 2017, the NGS Reference Virus Database version 10.2 (unclustered and clustered).

In support of the White House’s Precision Medicine Initiative, the FDA issued two draft guidances that offer a streamlined approach to the oversight of ‘Next Generation Sequencing’ tests that detect medically important differences in a person’s genomic makeup.