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

May 2007: Volume 33, Number 5

FDA Spells Out Stiffer Rules
for Advisory Committees
Responding to growing anxiety from its approval of controversial drugs, the FDA has instituted a new policy to avoid conflicts of interest for members of its advisory committees that give expert advice on scientific and policy matters. The new rules will simplify the determination of who can participate in the committees and provide greater consistency and transparency, the agency said. Explained in a draft guidance titled Guidance for Industry and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, the rules include a six-step algorithm designed to help FDA staff decide who can sit on expert panels. The tougher rules set a $50,000 threshold for any member’s financial interest, defined as the potential for the participant to gain or lose money as a result of the panel’s decisions. Also, people with “disqualifying financial interests,” even if they fall short of the $50,000 mark, cannot participate unless the need for their special expertise outweighs the potential for a conflict. The draft guidance will be available for comment until May 20. Click here to submit a comment, visit and reference docket number 2007D-0101. Click here for online guidance.
FDA Clears Roche’s anti-HBs and HBsAg Assays
Roche Diagnostics (Indianapolis, Ind.) announced the FDA clearance of the Elecsys antibody to hepatitis B surface antigen (anti-HBs) and hepatitis B surface antigen (HBsAg) assays for use on the Roche MODULAR Analytics E170 analyzer. Both assays employ electrochemiluminescence technology and offer an 18-minute turnaround time. The Roche analyzer can process up to 170 of the new tests per hour. The anti-HBs assay also was cleared as a quantitative test for the determination of HBV disease.
Fast Test for Meningitis Cleared
The FDA announced the clearance of the Xpert EV assay manufactured by Cepheid (Sunnyvale, Calif.). The test helps physicians distinguish between viral and bacterial meningitis and produces results in 2.5 hours, making it significantly faster than existing methods. The Xpert EV cartridge-based test is the first fully-automated assay that isolates and amplifies viral genetic material present in cerebrospinal fluid via a reverse transcription-polymerase chain reaction.
Four More Analytes Get Waived
Status on Piccolo Systems
Abaxis (Union City, Calif.) announced that tests for four analytes—calcium, creatinine, urea nitrogen, and uric acid—on the Piccolo and Piccolo Xpress POC analyzers received CLIA-waived status. Abaxis said the FDA decision brings the number of waived analytes on the Abaxis’ systems to 16, or 70% of the analytes the company sells.