Diagnostics In Brief
This article was originally published in The Gray Sheet
Executive Summary
First genetic test for warfarin sensitivity cleared: Nanosphere's Verigene multiplex nucleic acid test for genetic variations that influence metabolism of the common blood-thinner warfarin is 510(k)-cleared Sept. 17. FDA updated the labeling of warfarin in August to explain that patients with variations in the CYP2C9 and VKORC1 genes may respond differently to the drug (1"The Gray Sheet" Aug. 20, 2007, p. 9). Other firms developing warfarin test kits include AutoGenomics, Nanogen, Third Wave Technologies and Luminex
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Nanogen exits array business
Nanogen plans to close its array business and cut 20% of its staff to save about $15 million. The company originally announced it was considering dropping the business in September (1"The Gray Sheet" Sept. 24, 2007, p. 14). "Our analysis of alternatives for the array business has not resulted in any financially meaningful opportunities," COO David Ludvigson said Nov. 12. "The best way to meet our commitment to improving financial performance for our shareholders is to focus on our real-time PCR and point-of-care testing businesses." The restructuring will cost $6.9 million, charged to the third quarter, for inventory and assets related to the array business and $2.5 million in severance costs charged to the fourth quarter. The company will continue to supply most cartridges for the NanoChip electronic microarray system to customers through 2008