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Nanosphere Receives FDA Clearance for Verigene Gram-Negative Blood Culture Test

Jan. 14, 2014

Ill.-based Nanosphere announced receipt of FDA 510(k) clearance for its Verigene in vitro diagnostic test. The new test is capable of identifying genus and species of gram-negative bacteria and genetic resistance markers.

Nanosphere already markets a Verigene product for gram-positive bacteria. Whereas other tests for gram-negative and gram-positive bacteria often take two to four days to produce results, Verigene can provide answers within just two hours, the company maintains. The quicker turnaround time leads to more targeted patient care, reduced healthcare spending, improved outcomes and optimized antibiotic therapy, Nanosphere says.

The test consists of a cartridge that is loaded into the Verigene System processor, along with test consumables and the blood sample. The processor then prepares the sample and processes the test. Once that is done, the slide from the processor is inserted in the Verigene reader, which produces the results.

The company also makes gastrointestinal and respiratory infection tests and cardiac diagnostics. — Lena Freund

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