GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.
The firm said that the test, a hematology-based cellular biomarker that identifies morphological changes within monocyte white blood cells, could speed diagnosis.
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.
The firm said that its Vitros XT MicroSlides improve lab turnaround time by delivering simultaneous results for pairs of tests that physicians frequently order.
The firm said that it is now working toward obtaining the necessary regulatory classification to allow placement of its platelet testing devices in physician offices.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The firm has expansive plans, including a possible launch of 40 different types of tests. It currently plans to launch a liver function test in the US this summer.
The FDA said that the final rule is designed to ensure that manufacturers continue to use appropriate practices for Bacillus detection tests.