Alec Ritchie, Ph.D.
For each candidate test, the manufacturer is expected to provide sufficient information about the test to judge its merit and to establish procedures for performance of the assay.
The AsTeC Review Committee, comprised of the Principal Investigator (PI), Co-PIs, and the Project Officer, will prioritize experimental tests for evaluation using guidelines developed with the advice of a Scientific Working Group (SWG). The SWG is comprised of three external scientists knowledgeable in IA diagnostics and FDA requirements for in vitro diagnostic test evaluations.
Last Updated November 19, 2012