September 2008: Volume 34, Number 9
FDA Clears Osmetech’s Warfarin Sensitivity Test and Instrument
Osmetech announced the FDA clearance of its eSensor Warfarin Sensitivity Test for use as an aid in the identification of patients at risk for increased sensitivity to warfarin. The eSensor Warfarin Sensitivity Test detects three genetic markers known to play a role in warfarin’s metabolism. FDA also cleared the company’s eSensor XT-8 molecular diagnostics platform, a random-access, small-footprint microarray instrument. This is the third pharmacogenomic test cleared for warfarin dosing.
FDA Clears Pathwork Tissue of Origin Test
The second in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA, the Pathwork Tissue of Origin Test uses a microarray to analyze a malignant tumor’s gene expression pattern and pinpoint the source of hard-to-identify tumors. The test looks for 15 common tumor types, including bladder, breast, and colorectal tumors, and uses the PathChip gene expression array, a custom-designed microarray chip designed by Affymetrix. It is the first such custom chip from Affymetrix to achieve FDA clearance. According to Pathwork Diagnostics, up to 200,000 newly diagnosed cancer patients annually in the U.S. may have a tumor for which the site of origin is uncertain after the initial diagnostic workup.
Celera’s VirSeq HIV-1 Genotyping System Software v2.8 Cleared
Celera announced FDA clearance for its ViroSeq HIV-1 Genotyping System software v2.8. The system detects mutations in the HIV-1 viral genome that confer drug resistance, helping monitor HIV-1 infections. The updated software includes two additions to the resistance algorithm for new drugs—etravirine and darunavir—as well as updates to the resistance algorithm for all protease and reverse transcriptase inhibitors. The system also can now run on Intel dual-processor computers. The ViroSeq system features an automated DNA sequencing platform, reagents, and dedicated software. Abbott Laboratories distributes the system.
Response Biomedical’s POCT RAMP NT-proBNP Test Cleared
Response Biomedical announced the FDA clearance of its RAMP NT-proBNP test as an aid in the rapid diagnosis of heart failure. The test, run on the RAMP200 POC analyzer, is clinically concordant with the Roche Elecsys proBNP test. In clinical trials, the test provided results comparable to those produced by its automated
counterpart.
ABL80 FLEX Blood Gas Analyzer Cleared
Radiometer announced FDA clearance of its ABL80 FLEX CO-OX, a portable blood gas analyzer for POCT. The instrument measures pH, blood gases, electrolytes, glucose, and vital co-oximetry parameters. It also features an interval of 140 seconds between results, cartridge-based testing, sample size of 105 µL, self-cleaning sample inlet, automatic QC, and HIS/LIS connectivity.