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Shares in Nanogen Surge 21 Percent on News of FDA Clearance

NEW YORK, March 29 (GenomeWeb News) - Shares in Nanogen were up 21.11 percent, or $.57, at $3.27 in mid-afternoon trading after the company this morning said it won 510(k) clearance from the US Food and Drug Administration to sell one of its tests.

 

The product, called StatusFirst CHFNT-proBNP EDTA plasma test, is used to diagnose individuals suspected of having congestive heart failure. It is the first 510(k) clearance for Nanogen.

 

Nanogen said it will continue developing its StatusFirst CHF whole blood test with an eye for FDA clearance.

 

The cleared test is the result of a collaboration between Nanogen and Princeton BioMeditech Corporation. The companies co-developed and will co-market the product, Nanogen said.

 

PBM will manufacture the product under contract with Nanogen. The test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM.