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

February 2007: Volume 33, Number 2

FDA Approves First Blood Screening Test
for Chagas' Disease

Ortho-Clinical Diagnostics (Raritan, N.J.) announced that the FDA approved a new test designed to screen blood donors for exposure to Chagas' disease. Caused by Trypanosoma cruzi, a tropical blood parasite that originates in South America, the blood infection is also called Amercian trypanosomaisis. The ORTHO T.cruzi ELISA Test System is the first blood screening test for the disease approved for use in the U.S. In clinical trials, the test demonstrated 100% sensitivity to all geographic strains of the parasite. The disease can be treated soon after infection occurs, but there is no cure once the disease enters the chronic stage.

CellSearch Cleared for Breast Cancer

Veridex (Warren, N.J.), a Johnson & Johnson subsidiary, announced that the FDA granted an expanded clearance for the company's CellSearch System to be used as an aid in the monitoring of metastatic breast cancer. The CellSearch System counts circulating tumor cells in a blood sample, and the results predict progression-free survival and overall survival in patients with metastatic breast cancer earlier than current methods.

GBS Test Cleared

The FDA cleared the Cephid (Sunnyvale, Calif.) Smart GBS test on the company's SmartCycler Platform. The Smart GBS assay is a molecular assay intended for rapid detection of Group B Strep colonization in pregnant women. Test samples can be obtained directly from swabs in both the antepartum and intrapartum setting, or for higher sensitivity, a Lim broth pre-enrichment protocol can be used in antepartum applications.

New Guidance on CF Nucleic Acid QC Material

The FDA clarified how to bring quality control (QC) material for cystic fibrosis (CF) nucleic acid assays to market, classifying these QC materials as class II special controls with a new guidance, “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” Under class II rules, a company need only prove that its product compares favorably in safety and effectiveness to others already on the market. The guidance covers preanalytical factors, analytical performance, and labeling of the QC materials to ensure safety and effectiveness under the special controls rules of class II devices. This lighter regulatory burden of class II can lead to more new products entering the market. The guidance is available online.