FDA clearance

The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.

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 said that its new hematology-based cellular biomarker test has the potential to advance clinicians’ approach to sepsis triage and diagnosis.

The firm said that its Vitros XT MicroSlides improve lab turnaround time by delivering simultaneous results for pairs of tests that physicians frequently order.

Designed for small and medium-sized labs, the system offers automated blood typing and screening based on gel card technology with minimum user intervention.

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 FDA cleared the firm's Coag-Sense PT2 second-generation PT/INR monitoring system for professional use in a CLIA setting and by patients at home.

The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.

The Optigen AP 3600 can process up to 100 panels, or as many as 3,600 individual allergen results, in one day, and allows for true walk-away time, the firm said.