November 2008: Volume 34, Number 11
FDA Clears Novel Molecular MRSA/SA Test
Cepheid announced FDA clearance of its Xpert MRSA/SA skin and soft tissue infection test for the rapid detection of MRSA and staph. The test runs on the company’s GeneXpert system and processes swab specimens within 1 hour, making it the fastest FDA-cleared molecular test for this purpose. Current culture-based testing methods take 48–72 hours to determine if a skin or soft tissue infection is caused by MRSA or staph, prompting physicians and surgeons to often prescribe broad-spectrum antibiotics while they wait for test results.
TB Test Approved
Oxford Immunotec announced that its T-SPOT.TB test won FDA approval. The test is a cellular blood assay intended for use as an aid in the diagnosis of TB infection. The company’s studies demonstrated better than 95% sensitivity and specificity for the test, as well as reliability in targeted patient groups such as HIV-positive persons, recent contacts of TB case patients, patients with chronic renal failure, children, and immunosuppressed patients.
FDA Clears CDC Flu Test
The FDA announced it has cleared the rRT-PCR Flu Panel test for diagnosis of flu and H5N1. Developed by the CDC in collaboration with Applied Biosystems and the Association of Public Health Laboratories, the test panel can detect and identify commonly circulating human flu viruses as well as H5N1 viruses within 4 hours, testing multiple samples at once.
Gen-Probe Test Gets Additional Approval
Gen-Probe’s Procleix Ultrio assay received a supplemental FDA approval to screen donated blood for HBV. FDA previously approved the assay to screen donated blood for HIV-1 and HCV. The test is now approved to screen donated blood, plasma, organs, and tissue for the three viruses in individual donations or in pools of up to 16 blood samples. The test runs on the enhanced, semiautomatic Procleix system and on the fully automated Procleix Tigris system.
FDA Clears Five-Species Candida FISH Test
AdvanDx announced FDA clearance of its Yeast Traffic Light PNA FISH test that identifies Candida yeast species directly from positive blood cultures. Conventional methods can take up to 5 days to identify the infecting species, while the Yeast Traffic Light test identifies C. albicans, C. parapsilosis, C. tropicalis, C. glabrata, and C. krusei within hours so that physicians can provide earlier appropriate antifungal therapy for patients with candidemia.