This article has been updated to included comments from the company.
NEW YORK (GenomeWeb News) – Nanosphere has recalled several lots of its Warfarin Metabolism Nucleic Acid Test cartridges due to aberrant results, according to a notice recently posted on the US Food and Drug Administration’s website.
Northbrook, Ill.-based Nanosphere began the recall nearly two months ago. A company spokesperson told GenomeWeb Daily News that the recall was "promptly completed and had no material impact on the company's business or financial position."
According to the FDA’s April 9 notice, the reason for the recall is that a warfarin 2C9*2 mutant capture signal “was found to be high enough to result in an aberrant result.”
The lot numbers affected by the recall are: 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A.
In September, Nanosphere became the first firm to receive clearance for a genetic test for warfarin sensitivity. The test runs on the firm’s Verigene platform.
In January, privately held AutoGenomics received FDA clearance for its molecular test for warfarin sensitivity, which runs on that firm’s Infinity Analyzer. Several other molecular diagnostics firms are in the process of developing or seeking regulatory approval for their warfarin tests as well.
Warfarin, marketed as Coumadin by Bristol-Myers Squibb, is used to prevent potentially fatal clots in blood vessels. However, too much or too little of the drug in patients can cause serious, life-threatening bleeding or blood clots. Variability to warfarin response has been linked to mutations in two genes: CYP2C9 and VKORC1.