Summary
The FDA published document designed to help diagnostic test manufactures develop H1N1 tests and data that would accompany a FDA application to market them. This follows on the recent issuance of CDC guidelines for H1N1 tests.
Analysis
The FDA guidance document for H1N1 tests should help manufacturers develop the requistite data required for FDA approval and marketing. This new guidance document follows on the recently CDC issued guidelines that speak to the four clinical diagnostic methods used to test for H1N1. The tests vary in their ability to differentiate flu types, sensitivity, specificity and turnaround time for results.
Several companies offer different clinical diagnostic tests for flu in general and the H1N1 type in particular. The list of companies entering this potentially lucrative space continues to grow on a daily basis. These include the Focus Division of Quest Diagnostics (NYSE:DGX), Prodesse and others.
