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Diagenode already sells more than 30 real-time PCR tests that are CE-marked for the detection of bacteria, parasites, and viruses for multiple infectious diseases.
The Cobas vivoDx MRSA test uses new bacteriophage technology based on bioluminescence to detect bacterial colonization in nasal swabs.
The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow.
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.