PS01: Diagnostics Townhall Meeting - Hot Topics

Diagnostics devices/tests are going through considerable change with the advent of digital technologies, digital pathology, and the use of software that assist in clinical decision-making. In addition to these new and/or updated technologies, there are traditional assays that are not standardized across all manufacturers. To maintain excellence of diagnostic devices/tests, one of the requirements is that we are aware of all the factors that impact our industry and stay on top of the most recent feedback from the regulatory agencies and discuss the latest research. This session will be an open dialogue with FDA, academia, and industry expert statisticians. It will include discussions moderated by Estelle Russek-Cohen, a retired FDA statistician and professor who has experience in all 3 medical centers, and led by panelists, e.g. Noberto Pantoja Galicia and Chunrong Cheng with an open mic for anyone who wishes to join the conversation with the goal to learn from each other and share knowledge. Hot topics include: 1) discussion of the most recent CLSI guidelines used in CBER/CDRH for in vitro diagnostic device approvals, including EP-17, EP09, EP05, EP-34, among others 2) Down classification of diagnostics from PMA to 510k 3) Impact of novel blood tests to detect more than one type of cancer (Multi-Cancer Detection (MCD)) 4) Ongoing studies to establish reproducibility across platforms for companion diagnostics including tumor mutation burden, ctDNA evidence 5) AI algorithms including Large Language Models and their evaluation such as study designs, context for use, and possibly the need for supporting studies to establish performance in intended use population and setting 6) Digital Health Technologies used during drug trials, and 7) General discussion on the potential of seeking approvals for diagnostics in more than one region. This session is consistent with RISW 2025 theme of "Future in Statistics: Collaboration and Innovation in the AI/ML Era". This format of a diagnostics townhall was held in a previous workshop in 2023 and was very successful in part because of the audience participation and we expect that to continue. The exponential use of AI in diagnostic devices and in SaMD in recent years means there are new challenges to discuss, in particular the Marketing Submission Recommendations for a predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (Guidance for Industry and FDA). This would also have a wide appeal to statisticians who are also supporting companion diagnostics as well as imaging, wearables, and other technology in drug trials. We expect this session to be appealing to a wide variety of attendees.