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Nanosphere Gets FDA OK for Additional Targets on Enteric Pathogens MDx Test

NEW YORK (GenomeWeb) – Nanosphere today said that it has received US Food and Drug Administration 510(k) clearance for additional targets on its enteric pathogens molecular diagnostic test.

The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplex panel that runs on the firm's Verigene molecular diagnostics system.

When the FDA cleared part of the panel earlier this year, Nanosphere said the EP test could simultaneously identify 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 additional viral targets now included in the EP panel are norovirus and rotavirus.

The firm noted that that the Verigene EP is its second FDA-cleared test in the area of gastroenteritis, joining its Verigene Clostridium difficile Nucleic Acid Test (CDF).

Nanosphere's MDx menu now includes five tests targeting infections of the bloodstream, respiratory tract, and gastrointestinal tract. In addition to the Verigene EP test, the other tests in its portfolio include the Verigene Gram-Positive Blood Culture Test (BC-GP), the Verigene Gram-Negative Blood Culture Test (BC-GN), the Verigene Respiratory Virus Plus Test (RV+), and Verigene CDF, each of which is FDA-cleared and CE-marked.

Nanosphere's shares were up 27 percent at $.83 in Monday morning trade on the Nasdaq. Its stock rose nearly 27 percent on Friday after reports revealed billionaire investor George Soros had purchased shares in the firm during the second quarter of the year.

Nanosphere's stock recently hit a 52-week low of $.49, and last month it received a letter from Nasdaq notifying the company that its common stock had failed to meet the minimum required closing bid price of at least $1.00 per share during the previous 30 days.