Nanosphere, Inc. (NSPH) Receives FDA Clearance to Market the Verigene CYP2C19 Test

Nanosphere, a leading provider of advanced molecular diagnostics systems, announced that the U.S. Food and Drug Administration has granted 510(k) clearance, permitting the marketing of the company’s CYP2C19 Nucleic Acid Test on the automated sample-to-result Verigene System.

The Verigene CYP2C19 Test is indicated as an aid to help clinicians determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. In less than 2.5 hours, the Verigene CYP2C19 Test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient’s whole blood sample. The test gives physicians the crucial information they need to treat patients quickly and appropriately with the most effective drugs.

The achievement of receiving FDA clearance adds to Nanosphere’s growing array of FDA-cleared assays, which includes tests for gram positive bloodstream infections (BC-GP), respiratory viruses (RV+), hypercoagulation, and warfarin metabolism.

A molecular diagnostics platform with the capability of performing tests for genetic, infectious diseases, and protein targets on a single sample-to-result platform, the Verigene System’s ease of use and on-demand processing capability allow hospitals to generate time-critical results in a near-patient setting.

The CYP2C19 Test received CE IVD Mark in April 2011 for commercial distribution in Europe and all countries recognizing the CE Mark.

Based in Northbrook, Ill., Nanosphere is a developer, manufacturer, and marketer of the Verigene System, an advanced molecular diagnostics platform for detecting life-threatening infections and cardiovascular diseases. Easy to use and cost-effective, the platform allows simple, low-cost, and highly sensitive genomic and protein testing on a single platform.

For more information, visit www.nanosphere.us

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