IQuum H1N1 Test Gets Green Light for Emergency Use

“Better late than never,” they must have thought at IQuum headquarters. On the other hand, would the H1N1 pandemic have developed as some people predicted, these guys would be sitting on solid gold now. IQuum has received emergency use authorization from the FDA for its Liat Influenza A/2009 H1N1 Assay. This comes just four months after the company was awarded a fast track grant from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of a lab-in-a-tube based point-of-care test for pandemic novel influenzas. From just a nasopharyngeal swab, the assay detects the 2009 H1N1 influenza viral RNA in less than 30 minutes. During this time the system automatically performs sample purification, real-time PCR amplification and detection of a conserved region of the matrix gene of influenza A viral RNA and the hemagglutinin gene of 2009 H1N1 influenza viral RNA. The company claims an impressive 100% positive percent agreement and 100% negative percent agreement with conventional assays.
Press release: FDA Grants IQuum Emergency Use Authorization (EUA) for 2009 H1N1 Influenza Assay for CLIA ‘Moderate and High Complexity’ Certified Laboratories…
Product page: Liat Influenza A/2009 H1N1 Assay…