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Correction: Nanosphere Eyes FDA OK for Plavix Metabolism, Troponin Tests

The story has been updated to correct revenue estimates Nanosphere's CFO provided at the conference for tests in the company's pipeline.

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Nanosphere CFO Roger Moody told investors Wednesday at the 2011 Jefferies Global Healthcare Conference that the company has filed for US marketing clearance for a companion diagnostic test for assessing Plavix (clopidogrel) metabolism.

In addition, the company plans to file for US Food and Drug Administration approval for its troponin test and bloodstream infection panel during the year as part of its plan to have eight tests on the market during the next few years, each with revenues of about $50,000 per customer per year.

On the Plavix metabolism assay, Moody said the company's pre-market approval application is pending with the FDA, and while he didn't give a timeline on when Nanosphere anticipates it may get the OK, he said that when it does it will be the first test available in the US for evaluating whether a patient is successfully metabolizing the anti-platelet drug. Up to more than 60 percent of patients, Moody said may be genetically predisposed to poor metabolism of the drug.

While Moody claimed Nanosphere will be the first with such a test, in October 2010 the FDA cleared AutoGenomics' Infiniti CYP2C19 assay. Though the label for the test does not specifically state that the assay will be used as an aid for Plavix (clopidogrel) dosing, it is expected to be used for that purpose.

In addition, privately held Spartan Bioscience has said that it plans to file for FDA clearance of its CYP2C19 test for Plavix metabolism later this year, after introducing the test and its system last year for research use only.

Nanosphere's test is already on the market in Europe.

In addition to its Plavix test, Nanosphere expects to submit its bloodstream infection panel during the third quarter of this year, and its troponin I assay later this year. Other tests under development include an enteric panel and a C. difficile panel. Moody did not detail plans for FDA submissions for those assays.

In total, the company has three tests cleared in the US, the most recent one being its respiratory virus subtyping panel, which received 510(k) clearance in January. It also has three tests on the market in Europe.

Moody said that through the remainder of 2011, Nanosphere will continue its expansion efforts into Europe and plans to enter the Asian market. Its first foray into that region will be Japan, where it expects to establish a presence during the second half of this year.