NIH/FDA Next-Generation Sequencing and Radiomics Workshop (Overview)


The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) Joint Leadership Council Next-Generation Sequencing and Radiomics Working Group is hosting a virtual workshop on resource requirements for acceleration of clinical applications of next-generation sequencing and radiomics, including those using artificial intelligence. This meeting will bring together members of the scientific community to discuss how to overcome the “ground truth gap” that has frequently been identified as one of the limiting factors impeding high-quality research, development, validation, and regulatory science.

Goals for this workshop are to:

  • Identify and characterize critical resource gaps in these fields, especially relating to reference standards.
  • Explore the landscape of existing resources that might be leveraged to accelerate growth in the NGS and radiomics spaces.
  • Identify opportunities to support NGS and radiomic tool development and validation, especially those using technologies such as artificial intelligence (AI) and machine learning (ML).

Two Requests for Information (RFIs) related to the topics of this workshop have been published jointly by the Office of The Director, NIH and the U.S. FDA. Follow the links below to read the full notices, which include details on the background, areas of interest, and how to submit a response. Responses received before the workshop may be discussed at the event.

NOT-OD-21-162: Critical resource gaps and opportunities to support Next Generation Sequencing (NGS) test development, validation, and data interpretation, including through the use of technologies such as artificial intelligence (AI)/machine learning (ML)

NOT-OD-21-163: Request for Information: Critical resource gaps and opportunities to support radiological tool development and clinical data interpretation using artificial intelligence (AI)/machine learning (ML)

Please contact with any questions.