American Association for Clinical Chemistry
Better health through laboratory medicine
April 2007 Clinical Laboratory News: News From the FDA

April 2007: Volume 33, Number 4

First Fully-Automated WNV Assay Approved for Donor Screening 
The FDA announced its approval of a fully-automated version of Gen-Probe’s (San Diego, Calif.) Procleix West Nile virus (WNV) assay for use on the TIGRIS system. In 2005, the assay was approved for use on a semi-automated platform; however, the new, fully-automated assay detects WNV genetic material in plasma specimens from individual donors of blood, tissue, and organs. Labs can also use the assay to test pooled samples from up to 16 donors.
FDA Clears VZV IgG Assay 
DiaSorin (Stillwater, Minn.) announced the FDA clearance of its LIAISON varicella-zoster assay (VZV) assay. The test is the first fully-automated, chemiluminescent immunoassay that can determine if a VZV infection has previously occurred in a patient. The assay offers 35 minutes to first result and a turn-around-time of 90 results per hour. 
DNA Genotyping Test for HPV Now Under Review
In March, Roche Diagnostics (Pleasanton, Calif.) submitted the Amplicor HPV test to the FDA for review. The test, which uses Roche’s PCR-based technology, detects 13 of the more common high-risk HPV genotypes that may be present in a clinical sample. The FDA also accepted for review Roche’s Linear Array HPV Genotyping Test. This assay identifies which of the 13 high-risk genotypes is present in a clinical sample. A research prototype of the assay was used in a recently published study in JAMA (2007;297:813–819) that put the HPV prevalence in women age 14–59 at 26.8%. Currently, Digene (Gaithersburg, MD) is the only company with a screening test for HPV in the U.S. market.
Factor II and Factor V Assay Cleared 
AutoGenomics (Carlsbad, Calif.) received FDA clearance for its INFINITI system qualitative assay for Factor II and Factor V for use as an aid in the diagnosis of patients with suspected thrombophilia. The automated system detects Factor II G20210A and Factor V G1691A point mutations.