Diagnostics In Brief

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

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 (Also see "Personalized Genetic Test Info Added To Warfarin Drug Labeling" - Medtech Insight, 20 Aug, 2007.), p. 9). Other firms developing warfarin test kits include AutoGenomics, Nanogen, Third Wave Technologies and Luminex.

Nanogen sans microarrays?: San Diego diagnostics firm is considering selling or shutting down its microarray business, including its Nanochip instrumentation systems, as part of "an aggressive plan to achieve profitability." Nanogen plans instead to focus on its real-time PCR and point-of-care products including the Cardiac STATus test kit. The company says it expects to decrease expenses and improve cash flow by at least $15 million annually without the microarray business. Nanogen reported revenue of $10.3 million last quarter, up 60% from the prior-year period. However, its expenses also increased, accounting for a net loss of $14.5 million in the quarter, up from $11.8 million in 2006.

Celera acquires Atria Genetics: Applera's molecular diagnostics subsidiary buys Atria Genetics for $33 million in cash, the companies announce Sept. 20. Abbott Molecular has marketed Atria's human leukocyte antigen (HLA) products, used to identify bone marrow transplant donors, through an alliance with Celera since 2004. Following completion of the Atria acquisition, Celera will get 60% of the end-user revenues under the Abbott deal in addition to the low single-digit percentage royalty it is already earning. Atria's sales reached $12 million in 2006. Celera, based in Rockville, Md., and Alameda, Calif., expects to close the deal by year-end and incorporate all 13 of Atria's South San Francisco employees.

Blood transfusion testing: FDA clears two new blood screening products. On Sept. 14, the agency licensed Alba Bioscience's ALBAclone blood grouping reagents for determining a donor's blood type, which FDA says will help ensure a more stable supply of blood typing tests. On Sept. 18, the agency cleared the Platelet PGD test system, manufactured by Verax Biomedical, to detect bacterial contamination in blood platelets prior to blood transfusion. Both companies' products were reviewed by the Center for Biologics Evaluation and Research.