American Association for Clinical Chemistry
Better health through laboratory medicine
March 2008 Clinical Laboratory News: News From the FDA

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March 2008: Volume 34, Number 3

FDA Clears Second Warfarin Assay

AutoGenomics (Carlsbad, Calif.) announced the clearance of its Infiniti 2C9-VKORC1 Multiplex Assay for Warfarin, making it the second FDA-cleared assay for determining an individual’s sensitivity to warfarin. Last August, the FDA updated the labeling for Coumadin (warfarin) to include information about how genetic testing could guide initial dosing.

Then in September, FDA cleared the first genetic test for the drug, Nanogen’s Verigene Warfarin Metabolism Nucleic Acid Test. The new AutoGenomics test identifies patients with CYP 450 2C9 and VKORC1 genetic variants and offers simultaneous multiplexed determination of 15 genetic variants that characterize a wide spectrum genetic variants found in different ethnic populations. The assay works with whole blood or a wash of buccal cells. More information about the warfarin labeling change is online.

First-in-Class Breast Cancer Prognosis Kit Approved

Dako (Glostrup, Denmark) announced the FDA pre-market approval of its TOP2A FISH pharmDx assay. The test helps predict prognosis in high-risk breast cancer patients and is the first approved test for the TOP2A gene in cancer patients. Anthracycline-based chemotherapy for breast cancer targets TOP2A, and patients with normal TOP2A status have a better outcome than patients with TOP2A gene amplifications or deletions. The FDA said the test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics like size or lymph node involvement point to a higher risk of tumor recurrence or decreased survival.

HTLV-I/HTLV-II Blood Screening Test Cleared

Abbott (Abbot Park, Ill.) announced that the FDA okayed its HTLV-I/HTLV-II test, the first FDA-cleared, fully automated blood test kit that screens individual donations of blood and plasma for antibodies to HTLV-I and HTLV-II. The two are related retroviruses that are associated with human T-cell leukemia and neurological disorders. The test runs on the Abbott Prism instrument.

Final Guidance Issued on CLIA Waivers

A new FDA guidance aims to help manufacturers understand how to demonstrate that their devices are worthy of a CLIA waiver. The final guidance, titled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, includes a greater emphasis on scientifically-based flex studies and validation or verification studies, acknowledgement that reference methods are not available for all device types, new emphasis on QC, as well as a focus on intended users during studies testing the device. The guidance also covers updated study recommendations on use of patient specimens in an intended-use environment over time. The document is available online on the FDA Web site.