American Association for Clinical Chemistry
Better health through laboratory medicine
April 2009 Clinical Laboratory News: News from the FDA

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April 2009: Volume 35, Number 4

Warfarin Genotyping Test Cleared by FDA

TrimGen has received 510(k) clearance from FDA for its new eQ-PCR Warfarin Genotyping kit, designed to test for SNPs in the VKORC1 and cytochrome P450 Cyp2C9 genes that serve as predictors for warfarin dosing. The assay will allow physicians to identify patients who may be at risk for warfarin sensitivity. Warfarin is currently one of the most commonly prescribed anticoagulants in the U.S. TrimGen joins several other firms, including Nanosphere, Autogenomics, ParagonDx, and Osmetech, that have received FDA clearance for warfarin sensitivity tests.

Abbott Receives 510(k) Clearance for Hematology Instrument

FDA has granted 510(k) clearance to Abbott for its new hematology instrument, Cell-Dyn Emerald. The new device is capable of analyzing blood for a variety of disorders, including anemia and infections. It also provides complete blood counts and features an electronic touch screen and compact size, suitable for small and mid-sized clinical laboratories. 

BioImagene Receives FDA Clearance for Digital Pathology Hardware

FDA has given 510(k) clearance to BioImagene PATHIAM System with iScan for assessment of HER2/neu immunohistochemistry tests. The scanner and associated software are used to detect and provide quantitative measurement of HER2/neu, a protein measured in breast cancer patients in order to determine if they are candidates for treatment with the cancer drug Herceptin. “This FDA clearance is a significant accomplishment for BioImagene and validates the innovations in our digital pathology hardware and software,” commented Dr. Ajit Singh, CEO of BioImagene. “Many pathology workflow innovations are possible only by going digital. This clearance will help increase adoption of digital pathology and accelerate the progress toward personalized medicine.”

FDA Releases Personnel Directory

FDA has released a personnel directory with contact information of key officials, organized by center and division. A second issue is expected to be released in July to include new listings of top officials from the Obama administration. The directory is available for purchase via subscription at the FDA website.

FDA Merging Operations with Relocation Project

FDA is consolidating its labs and offices into a 662-acre former military compound known as the Naval Surface Warfare Center, located in White Oak, Md. outside of Washington, D.C. The $1.15 billion project includes 14 new buildings and 3.1 million square feet of labs and offices and is expected to serve as a new hub for biotech research in the area. About 3,700 FDA employees already are stationed in White Oak, with 1,100 more currently arriving, but about 8,800 could work there by 2012. The move is part of an effort by the General Services Administration to make better use of real estate currently owned by the federal government, and is expected to save FDA $10 million annually in rental fees.