News from the FDA

Clearance for Siemens Syphilis Assay

FDA cleared Siemens Healthcare Diagnostics' ADVIA Centaur Syphilis Assay for market. The test is designed to detect antibodies against Treponema pallidum, a bacterium known to cause the sexually-transmitted disease, syphilis.

Qiagen's Influenza A/B Assay Cleared

Qiagen received FDA clearance to market its multiplex real-time polymerase chain reaction test for detecting Influenza A/B, the Artus Infl A/B RG RT-PCR Kit. It is designed to help in differential diagnosis of Influenza A and B infections by qualitatively detecting and identifying virus in nasopharyngeal swab samples. The test runs on the company's Rotor-Gene Q MDx instrument.

Great Basin's C. difficile Test Approved

Great Basin received FDA approval for its first molecular diagnostic test for Clostridium difficile. The C. difficile test is based on a technology that uses an integrated disposable cartridge containing all necessary reagents. It runs on a benchtop analyzer that executes the assay, interprets the results, and provides electronic output to the clinician.