One-hour test for MRSA and staph approved
Cepheid (Sunnyvale, Calif.) received FDA approval of its Xpert MRSA/SA Blood Culture test for the detection of methicillin- resistant Staphylococcus aureus (MRSA) and S. aureus in blood culture bottles showing Gram-positive cocci. The 1-hour test runs on the company's GeneXpert System.
Same-day diagnostic results for blood culture bottles growing Gram-positive cocci allow practitioners to begin targeted therapy in septic patients far sooner than current culture-based methods, can potentially improve antibiotic stewardship, and ultimately provide patients with an effective therapeutic regimen.
New test detects human influenza infections
The FDA approved a new test developed by the CDC to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses. The Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel can differentiate seasonal from novel influenza infections. Results can be available within 4 hours and the system can test multiple samples at once.
The test provides better support for labs on the frontline of influenza testing in the United States and abroad, and may be especially important in the early stages of a pandemic.
The test is currently available to CDC-qualified labs for diagnosing influenza, with some laboratories able to obtain reagents at no cost.
Drug-eluting stent treats small vessels
Boston Scientific Corporation's (Natick, Mass.) TAXUS Express2 Atom Paclitaxel-Eluting Coronary Stent System was approved for treating small coronary vessels. It is the only drug-eluting stent approved by the FDA for use in vessels as small as 2.25 mm in diameter.
The company also received FDA approval of its TAXUS Express2 Paclitaxel-Eluting Coronary Stent System for the treatment of in-stent restenosis in bare metal stents. This is the first such approval granted in the United States for the treatment of in-stent restenosis in bare metal stents.
Test IDs Candida yeast species
AdvanDx (Woburn, Mass.) received FDA approval for its Yeast Traffic Light PNA FISH test to identify Candida yeast species directly from positive blood cultures. The test is an addition to the company's molecular-based peptide nucleic acid fluorescence in situ hybridization (PNA FISH) diagnostics platform, which provides rapid identification of bloodstream pathogens in hours instead of days.
The test allows the identification of up to five Candida species in a single Yeast Traffic Light test in a matter of hours, including C. albicans and C. parapsilosis, C. tropicalis, and C. glabrata and C. krusei. The rapid identification of Candida species enables clinicians to provide early, effective, and appropriate antifungal therapy for patients.
ELISA detects bullous pemphigoid
MBL International Corporation's (Woburn, Mass.) BP180 and BP230 enzyme-linked immunosorbent assay (ELISA) kits for the detection of bullous pemphigoid (BP) were approved for U.S. marketing.
The new kits present a significant advance in testing for BP, which may lead to better treatment. The kit is highly specific, sensitive, and has a combined correlation of greater than 90% when compared with the immunofluorescence method.