November 2007 Clinical Laboratory News: News From the FDA

November 2007: Volume 33, Number 11

FDA Clears First Rapid Test for
 Bacterial Contamination in Blood Platelets

Verax Biomedical (Worcester, Mass.) announced FDA clearance of its Platelet PGD test system, which cuts detection time for bacterial contamination in leukocyte reduced apheresis platelets to about 30 minutes. Consisting of a disposable strip for use in a hospital transfusion service setting, the test can be used after platelets have entered the inventory and gives laboratories the ability to detect contaminated units that might otherwise slip past current testing methodologies.

First Genetic Test for Warfarin Sensitivity Cleared on New Nano-tech Analyzer

Nanosphere (Northbrook, Ill.) announced FDA clearance of its Verigene warfarin metabolism nucleic acid assay, making it the first cleared test to help assess who might be especially sensitive to warfarin (Coumadin). The clearance comes on the heels of FDA’s updated labeling for warfarin that contains information about how genetic variations might mediate a patient’s sensitivity to the drug.

The FDA also recently gave the nod to Nanosphere’s Verigene System analyzer, on which the FDA cleared the new Coumadin sensitivity test to run. The Verigene instrument is a random access, molecular diagnostics workstation for nucleic acid and protein diagnostics, and it uses gold nanoparticles to detect nucleic acid targets in a multiplex format. It incorporates reader and processor components, as well as single use, disposable test cartridges.

      IL Second Generation PT Reagent Cleared

Instrumentation Laboratory (IL, Lexington, Mass.) announced that the FDA cleared its HemosIL RecombiPlasTin 2G PT reagent. It is based on recombinant tissue factor and a blend of synthetic phospholipids, which allow better sensitivity and lot-to-lot consistency, according to IL. The reagent is also insensitive to the new antibiotic Cubicin and has an ISI value of approximately 1.0 on IL’s ACL analyzers, traceable to WHO standards.

   FDA Releases Guidance on ASR FAQs

Aiming to clear any confusion on the definition and marketing rules for ASRs and their use in laboratory developed tests (LDTs), “Guidance for Industry and FDA Staff, Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions” elaborates on the definition of ASRs, provides examples of what is and is not an ASR, and works to sharpen the focus of manufacturers trying to figure out they can market ASRs appropriately. According to the guidance, ASRs are: used to detect a single ligand or target (e.g. protein, single nucleotide change, epitope); not labeled with instructions for use or performance claims; and not promoted for use on specific designated instruments or in specific tests. FDA also makes a point to distinguish between indicating the affinity of a reagent and describing a specific clinical use of a reagent, with the later prompting the agency to no longer view it as an ASR. The guidance document is online.

 IL Gets Expanded Clearance for D-Dimer HS Assay

Instrumentation Laboratory (Lexington, Mass., IL) announced expanded FDA clearance for the intended use of its HemosIL D-Dimer HS assay. The assay can now be used to exclude venous thromboembolism (VTE) in outpatients suspected of deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability assessment model. IL released the assay in 2005 with claims for use as an aid in the diagnosis of VTE. In data submitted as part of the 510(k) from a multi-center clinical study with 668 samples from patients suspected of having DVT or PE, HemosIL D-Dimer HS safely excluded DVT or PE with a negative predictive value of 100%.






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