December 2007 Clinical Laboratory News: News From the FDA

December 2007: Volume 33, Number 12

Second Test Cleared for Nanosphere’s Verigene System

Nanosphere (Northbrook, Ill.) announced the FDA clearance of its Verigene F5/F2/MTHFR nucleic acid test that detects gene mutations associated with blood coagulation disorders and problems metabolizing folate. The assay identifies mutations in three genes—F5, F2, and MTHFR—that together can increase a person’s risk for developing blood clots. Both the F5 and F2 genes encode proteins involved in coagulation, and the F2 protein is an active precursor of thrombin. The MTHFR gene encodes an enzyme important to synthesis of the primary circulating form of folate.

CDRH Posts List of Guidance Docs for 2008

The FDA’s CDRH released a list of the guidance documents it wants to tackle next year, encouraging stakeholders to submit comments, draft language, as well as suggestions for new or different guidance documents they’d like to see the agency consider. CDRH emphasized that it probably will not get to all the items on the list, as its staff are frequently called off to review premarket submissions or to work on unplanned guidance documents for de novo devices. Highlights of the list include Assay Migration Studies for IVDs, Clinical Trials Using De-identified Leftover Samples, IVDs for Detection and Differentiation of Influenza Viruses, HCG Tests, IVDMIAs, and CLIA Categorization Procedures and CLIA Waiver Applications. The full list, including instructions on how to submit comments, is available online.

     Rapid HIV Test Gets CLIA Waiver 

Chembio Diagnostics (Medford, N.Y.) announced that the FDA has granted a CLIA waiver for its rapid HIV test kit, which is marketed by Inverness Medical Innovations (Waltham, Mass.) as the Clearview COMPLETE HIV 1/2 test. The test is a single-use, self-contained, closed system for collecting, processing, and analyzing whole blood, serum, or plasma for the detection of HIV 1 and HIV 2 antibodies.

   Two Quest POC Tests Cleared

Quest Diagnostics (Madison, N.J.) announced that its HemoCue (Lake Forest, Calif.) and Focus Diagnostics (Cypress, Calif.) subsidiaries received FDA clearance for two new POC tests. The HemoCue WBC analyzer uses a whole-blood test performed on finger-stick samples to help physicians diagnose infection, inflammation, and other conditions. The HerpeSelect Express HSV-2 test, from Focus Diagnostics, aids in the diagnosis of herpes simplex-2 virus.

  TB Test Approved

Cellestis (Valencia, Calif.) announced FDA approval of its QuantiFERON-TB Gold In-Tube assay. The blood test detects cell immune responses to proteins associated with TB infection, replacing the original QuantiFERON-TB Gold test. According to Cellestis, the new assay offers the same specificity and accuracy, but adds the in-tube format to simplify testing and better fit with existing lab equipment.

   Sepsis Risk Assessment Assay Cleared

bioMérieux (Marcy l’Étoile, France) announced FDA clearance to market the VIDAS BRAHMS PCT test. The first automated test for measuring procalcitonin in the U.S., the assay is intended for use with critically ill patients on their first day of admission to the ICU as an aid to determine their risk for progression to sepsis and septic shock. bioMérieux licensed the use of procalcitonin from BRAHMS AG (Hennigsdorf, Germany) in 2005 for use on its VIDAS immunoassay instrument.






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