Becton Dickinson said this week that it has received US Food and Drug Administration clearance to market BD Max StaphSR Assay for use on the BD Max automated molecular testing system.
The new assay is designed to detect Staphylococcus aureus and methicillin-resistant S. aureus DNA directly from nasal swabs in approximately two hours. It can detect mecA dropout mutants and other new strains of MRSA that may not be detected by other assays, BD said.
The company added that its test is the first and only commercially available molecular assay in the US that detects recently discovered MRSA strains with the mecC gene.
The BD Max StaphSR Assay joins a portfolio of assays including the BD Max MRSA and BD Max Cdiff for detection of toxigenic Clostridium difficle DNA, which are already commercially available on the BD Max platform.
Roche said this week that it has received 510(k) clearance from the US Food and Drug Administration for the use of four additional specimen types with the Cobas CT/NG v2.0 test to help physicians diagnose Chlamydia trachomatis and Neisseria gonorrhoeae infections in symptomatic and asymptomatic patients.
In addition to self-collected vaginal swabs (collected in a clinical setting) and male urine specimens, the test may now be used with endocervical and clinician-collected vaginal specimens, female urine specimens collected in Cobas PCR media, and cervical specimens collected in PreservCyt solution.
The clinical performance of the Cobas CT/NG v2.0 Test using the additional specimen types was validated in the VENUS Studies, which included 6,004 patients (5,266 females and 738 males), representing more than 26,000 specimens collected in two clinical studies.
"With the addition of these specimen types, the Cobas CT/NG v2.0 Test now provides US labs with a comprehensive offering for chlamydia and gonorrhea testing," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "This will enable more labs running the Cobas 4800 System to combine CT/NG and HPV testing onto a single automated platform and further optimize their workflow."
The Cobas CT/NG v2.0 Test is a qualitative in vitro test for the detection of CT/NG DNA in patient specimens. It uses PCR amplification and nucleic acid hybridization to detect CT/NG DNA in a single analysis. It runs on the Cobas 4800 System, which automates nucleic acid purification, PCR set-up, and real-time PCR amplification and detection.