The firm noted that its study showed strong performance data, including high sensitivity and high specificity, in providing results direct from blood.
GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
Its product revenues were up 30 percent year over year, but research revenues decreased 89 percent. The firm posted $329,000 in grant contribution revenues.
The company has split bloodstream infection testing into three multiplex panels that can detect a total of 56 pathogen targets and 10 markers of antimicrobial resistance.
The firm said that the test, a hematology-based cellular biomarker that identifies morphological changes within monocyte white blood cells, could speed diagnosis.
Industry executives said that clinical needs associated with antimicrobial resistance and sepsis are generating more interest in AST technologies.
The firm said that its new hematology-based cellular biomarker test has the potential to advance clinicians’ approach to sepsis triage and diagnosis.
The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.
Immunexpress received US clearance for a direct-from-blood sepsis test in 2017 and recently won a contract to commercialize a sample-to-answer sepsis assay.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.