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

August 2007: Volume 33, Number 8

FDA Clears First Rapid Blood Test for Malaria

In contrast to standard lab tests for malaria that involve a microscope, the Binax NOW Malaria Test offers results in 15 minutes and uses only a few drops of blood on a dipstick, the FDA said when announcing marketing clearance for the test. The Binax NOW assay, made by a unit of Inverness Medical Innovations (Waltham, Mass.), also differentiates the most dangerous malaria parasite from the less virulent. The Binax NOW test was 95% accurate compared with standard microscope diagnosis, the FDA said. Results of the assay must still be confirmed with standard microscopic methods.

Sysmex Urinalysis Analyzer Cleared

Sysmex (Mundelein, Ill.) announced FDA clearance of its UF-1000i Automated Urinalysis Analyzer, a particle analyzer that classifies urine-formed elements with minimal operator intervention. The company’s newest urinalysis system since the UF-50 in 2002, the UF-1000i offers high-precision counts for white blood cells and red blood cells, improved sensitivity for pathological casts, and enhanced analysis information for the screening of patients with kidney disease, among other updates. Sysmex also added new reagents for better discrimination of particles.

FDA Issues Final Guidance on Genetic Tests

Completing the draft guidance that the agency issued in February of 2006, the FDA announced the availability of “Pharmacogenetic Tests and Genetic Tests for Heritable Markers.” The guidance document covers what information companies need to include in their submissions in order to get FDA clearance for these types of tests, which include pharmacogenetic tests with single markers, multiple markers, or multiplex tests, as well as array-based tests. The guidance touches on preparing the application for the FDA, such as device design, analytical studies, software, and comparison studies; it also discusses labeling, and includes an appendix to help manufacturers plan and evaluate their clinical studies. The FDA said in the guidance that its goal is to facilitate progress in the field of pharmacogenomics by shortening development and review times, and generally help move pharmacogenetics from research into informed clinical use.