FDA to Hold Workshop on Proteomics in the Clinic

The FDA is looking for public input on how best to develop a regulatory scheme for transforming research-level assays into validated in vitro diagnostics for broad patient use.

A June 13 public workshop will focus on the challenges to evaluating the safety and effectiveness of IVD tests that use technologies based on proteomics — the study of large-scale proteins and their interactions in people. Among variables facing clinical development of such assays are technological approaches, variety of sample types and preparation methods, data capture and analysis algorithms, the agency says. 

Topics for discussion during the one-day workshop include the state-of-the-art of proteomic IVDs and the FDA’s perspectives, public and private initiatives to standardize proteomic technologies and ensure quality control, and FDA experience clearing IVDs that use proteomic technologies.

The workshop will take place at the FDA’s White Oak campus in Silver Spring, Md., and will also be webcast. The deadline for registration is June 4. View the Federal Register notice. — Meg Bryant

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