American Association for Clinical Chemistry
Better health through laboratory medicine
December 2010 Clinical Laboratory News: News from the FDA

News from the FDA

Rheumatoid Arthritis Blood Test Cleared

Bio-Rad Laboratories and Axis-Shield have received FDA clearance for Bio-Rad’s BioPlex 2200 Anti-CCP test for the early detection of rheumatoid arthritis. The clearance also marks the test’s U.S. launch. The BioPlex 2200 Anti-CCP assay is based on Axis-Shield’s proprietary anti-CCP technology. The test runs on Bio-Rad’s BioPlex 2200 system and measures anti-cyclic citrullinated peptide antibodies, a biomarker that has shown to have superior specificity in diagnosing rheumatoid arthritis. 

FDA Laboratory Earns A2LA Accreditation

FDA announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System program in the Center for Biologics and Evaluation Research (CBER) under ISO/IEC 17025 in the fields of biological and chemical testing. The ISO/IEC 17025 is a standard developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) to combine requirements for technical competence in testing and calibration laboratories with requirements for quality systems. CBER received accreditation for six methods to test influenza vaccines, including those for sterility and potency, and seven methods for evaluating blood donor screening kits that indentify HIV, HBV, HCV, HTLV-I/II, Trypanosoma cruzi, and West Nile virus.

FDA Approves HER2 Tests for Gastric, Stomach Cancer

Dako has received FDA approval to expand the use of its HercepTest and HER2 FISH pharmDx Kit to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer). The company’s tests are designed to aid in the assessment of patients for whom Herceptin (trastuzumab) is being considered. FDA approved the use of Herceptin in combination with chemotherapy for HER2-positive, metastatic stomach cancer or cancer of the gastroesophageal junction.