Based in Warsaw, Poland, the technology was inspired by "ultra-fast" PCR methods from the Wittwer group and Scope plans to launch tests for MRSA and C. diff.
The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.
GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.
An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
Since moving to rapid molecular testing, the lab has doubled its billable test volume, largely through increasing clients for its outreach lab services.
The company is recalling cards for cefoxitin and oxacillin after it determined they can provide false results for some strains of MRSA, the FDA said.
Collaborators said that the test is accurate and reliable for the rapid detection of the most common gram-positive bacteria responsible for bloodstream infections.
At the recent CVS, the two large health systems described introducing Cepheid platforms for flu testing across rural and satellite locations.
A rapid PCR respiratory panel enabled the hospital to avoid antibiotics in 89 out of 295 pediatric patients in a one-year period.