FDA’s response on Troponin Assay Anticipated (NASDAQ:NSPH)

Nanosphere Inc. (NASDAQ:NSPH) is a pharmaceutical company that develops, manufactures and then brings into market “advanced molecular diagnostics systems” which detect “multiplexed direct genomic and ultra-sensitive protein detection”. All its products are based on the company’s trademark Verigone(R) system. It has developed troponin assay especially for the flu season and has submitted an application to the FDA to market this. The company expects to get the response on its submitted application from the FDA on January 31, 2010. The announcement was made rather indirectly on the company’s financial results for the quarter July 2009 – September 2009 that were published in November 5, 2009.

The company hopes that the fate of the troponin assay would be similar to that of several other products under its pipeline. One example is the test that the company has developed in the last detect to detect the types A and B of the influenza virus. The test can also detect respiratory syncytial virus (RSV). The test is also fully automated throughout the diagnosis process: from the time the sample is taken to the point the result is given out. However, the company had to get the approval of the United States of America’s toughest regulator the Food & Drug Administration to get the regulator’s approval to bring this newly developed test in the market. For this reason, the company submitted an application – namely, the 510(K) – to get the marketing approval in the early 2009. In October 13, 2009, the company announced that the FDA has approved their submitted 510(K). This meant that the company was now allowed to market the test.

Mr. William Moffitt, who is the Chief Executive Officer and also the President of Nanosphere Inc., said:

“We are very pleased to receive clearance to provide our customers a better performing and easier to use solution for diagnosing influenza and RSV viruses in time for this flu season. The attention drawn to this flu season has highlighted the need for a respiratory virus test that offers better sensitivity than the rapid strip tests and faster and easier testing than cultures or currently available molecular tests. Our assay addresses these needs and demonstrates the power and flexibility of the Verigene System. Nanosphere’s respiratory virus assay run on the Verigene SP platform provides clinicians with the first sample-to-result system that combines the benefits of high sensitivity and specificity with ease of use and rapid turn-around time.”