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Nanosphere cleared to include H1N1 info on flu test label

This article was originally published in Clinica

Executive Summary

Nanosphere can now include claims of H1N1 virus detection in the package insert for its respiratory syncytial virus test on the Verigene SP system. The US FDA has granted a 510(k) clearance for the firm to include data on "reactivity with influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus". The RT-PCR-based test can correctly identify influenza A in samples containing this year's H1N1 virus, but cannot identify flu subtypes (such as H1N1). The performance of the assay with specimens positive for H1N1 has not been established, Nanosphere (Northbrook, Illinois) conceded. The test was cleared on the firm's next-generation system in October (www.clinica.co.uk, October 15 2009).

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