Harnessing Critical Experience To Plan And Execute A Dual-Submission Study

Background

Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires thoughtful trial design and data collection.

Objective

A sponsor approached Premier Research with a single-use, multiplexed, molecular, POC test to qualitatively diagnose influenza A and B, by detecting viral RNA in nasal swabs from symptomatic patients. Our task was to obtain sufficient data to support a dual 510(k)/CLIA Waiver submission. To succeed, we needed to develop a clear strategy to ensure that the data necessary to support both 510(k) clearance and CLIA waiver would be collected within a single clinical trial.