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Nanosphere (NSPH): FDA Authorizes Marketing Of Mutations Detection Test

 November 13, 2012 09:41 AM

(By Balachander) Nanosphere Inc. (NASDAQ: NSPH) announced that it has received authorization from the U.S. health regulators to market test for detection of CYP2C19 mutations affecting drug metabolism.

The Northbrook, Illinois-based company said its Verigene Nucleic Acid Test (CYP2C19) is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway.

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of Nanosphere's CYP2C19 test on the automated sample-to-result Verigene system.

According to Nanosphere, the Verigene System is a molecular diagnostics platform capable of performing tests for genetic, infectious disease and protein targets on a single sample-to-result platform.

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The Verigene CYP2C19 test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient's whole blood sample in less than 2.5 hours.

In April 2011, the CYP2C19 Test received CE IVD Mark for commercial distribution in Europe.

The FDA has cleared the company's assays, which includes tests for gram positive bloodstream infections (BC-GP), respiratory viruses (RV+), hypercoagulation, and warfarin metabolism.

The BC-GP test provides identification of bacteria and antimicrobial resistance genes from gram-positive blood culture bottles within two and a half hours, as compared with current microbiological methods, which can take up to two to three days, the company said.

On Tuesday, shares surged 10.74 percent to trade at $2.92.

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