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Great Basin Scientific Confirms FDA Clearance For Multiplex Panel


Shares of Great Basin Scientific Inc (NASDAQ: GBSN), a nano-cap molecular diagnostic testing company that focuses on testing infectious diseases, gained more than 10 percent on Monday.

Great Basin Scientific announced earlier in the morning it has received U.S. Food and Drug Administration 510(k) clearance for its Staph ID/R Blood Culture Panel.

Staph ID/R Blood Culture Panel is a sample-to-test, automated, DNA multiplex assay for identification of Staphylococcus aureus and Staphylococcus species directly from positive blood cultures in about two hours.

Great Basin Scientific noted the clearance marks its first multiplex panel to receive FDA clearance. The company added that the FDA's approval adds to the "value and versatility" of its analyzer.

"Receiving FDA clearance for our Staph ID/R Blood Culture Panel — our second FDA clearance this month — marks a major milestone in our growth as a Company," said Ryan Ashton, cofounder and Chief Executive Officer of Great Basin Scientific. "This menu expansion to four products, along with the five tests we plan to bring to clinical trial in 2016, will add further value for our customers who rely on our analyzer system to perform a greater variety of tests. The customer feedback we've received is that we are truly meeting the needs of the small and midsized hospital labs with our superior menu versatility, cost efficiency and customer service."


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Posted-In: Great Basin Scientific Molecular Diagnostic Testing Ryan Ashton Staph ID/R Blood Culture PanelNews FDA