Becton Dickinson said this week that its BD MAX MRSA molecular test has received a CLIA moderate complexity rating.
Performed on the automated BD MAX system, the assay is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus. A moderate complexity rating allows the BD MAX MRSA assay to be performed by a qualified laboratory technician.
Earlier this year, the BD MAX GBS assay for Group B Streptococcus received a moderate complexity rating.
Germany's SIRS-Lab said this week that it has completed recruitment for a 1,000-patient trial to evaluate its Vyoo pathogen-detection assay for patients with suspected sepsis.
The prospective, blinded multicenter study focused on ICU patients at 13 key medical centers across Germany, SIRS-Lab said.
The Vyoo molecular test combines highly multiplexed qPCR with microarray analysis to identify molecular signatures of a variety of pathogens implicated in sepsis. The assay also uses a proprietary sample prep method that concentrates pathogen DNA from complex samples such as whole blood.
SIRS-Lab commenced the trial in March (PCR Insider, 3/24/2012). At the time, the company said that results would be available this year. This week, however, the company said that it expects results from the trial in 2013.
SIRS-Lab obtained CE marking for the current Vyoo test in May 2012. The company said this week that it has continued to invest in further automating Vyoo, reducing hands-on time for laboratory technicians to 70 minutes per run with an overall test time of seven hours.