Nanogen gets FDA clearance of StatusFirst test for congestive heart failure

By Lisa Kerner

Erie, Pa., March 29 - Nanogen, Inc. said it received 510(k) clearance from the Food and Drug Administration to market StatusFirst CHF, a plasma test to aid in the diagnosis of congestive heart failure (CHF).

"This is the first 510(k) clearance earned by Nanogen and is a significant milestone," chairman and chief executive officer Howard C. Birndorf said in a company news release.

"The StatusFirst CHF 510(k) plasma clearance will permit us to begin the commercial launch of our CHF test. We will continue our development work to achieve clearance of the StatusFirst CHF whole blood test, which would significantly expand the potential market for our CHF product."

Nanogen said it will co-market the StatusFirst CHF with Princeton BioMeditech Corp., an established rapid diagnostic test manufacturer and co-developer of the product.

Princeton BioMeditech will manufacture the StatusFirst CHF NT, which is sold in conjunction with its DXpress reader.

Nanogen is a San Diego-based developer of diagnostic products.

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