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FDA Clears Part of Nanosphere's Enteric Pathogens MDx Test

NEW YORK (GenomeWeb) – Nanosphere said after the close of the market Tuesday that the US Food and Drug Administration has granted 510(k) clearance for a part of the firm's Enteric Pathogens Nucleic Acid Test.

Specifically, the FDA cleared for marketing the bacterial portion of the assay. The EP test simultaneously identifies a panel of community-acquired pathogenic bacteria and genetic virulence markers directly from a stool sample. Bacterial targets in the panel include Campylobacter, Salmonella, Shigella, Vibrio, Yersinia enterocolitica, and Shiga toxin gene 1 and 2.

The firm added that the test provides results in two to three days faster than conventional identification methods.

Nanosphere said that it will submit additional data to the FDA for the two viral targets, norovirus and rotavirus, that will be included in the test.

"FDA clearance of Verigene EP further strengthens our portfolio of multiplexed molecular gastrointestinal tests and expands our ability to deliver clinical, economic, and workflow benefits to those hospitals and laboratories which have adopted our Verigene System," Nanosphere President and CEO Michael McGarrity.

Earlier this year the FDA cleared for marketing the firm's 14-target Verigene Gram-Negative Blood Culture Test, a rapid in vitro test that, in addition to identifying more than 90 percent of gram-negative bacteria associated with bloodstream infections.

In Wednesday morning trade on the Nasdaq shares of Nanosphere were up 13 percent at $1.61.

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