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FDA Clears Nanosphere's Respiratory Pathogen Test

NEW YORK (GenomeWeb) – Nanosphere today announced that it has received 510(k) clearance from the US Food and Drug Administration for its Verigene Respiratory Pathogens Flex test (RP Flex).

The RP Flex PCR-based test features new software that allows the Verigene System to identify 16 viral and bacterial targets, either as a full multiplexed panel or in user-defined subsets.

"Verigene RP Flex addresses a previously unmet healthcare need for our laboratory customers by bridging the gap between one-size-fits-all syndromic panels and targeted single-analyte tests," Nanosphere CEO Michael McGarrity said in a statement.

The test is the fifth FDA-cleared test in Nanosphere's menu of infectious disease diagnostics for the Verigene system. It follows the Verigene Gram-Positive and Gram-Negative Blood Culture Tests, the Enteric Pathogens test, and the Clostridium difficile test.

In October 2014, Nanosphere received FDA clearance to add norovirus and rotavirus to its Enteric Pathogens test.

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