The RNA-based blood test takes less than five hours to detect the presence or absence of infection in patients who may have sepsis.
The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
GenMark's CEO said that the firm continues to focus on growing the ePlex instrument's global reach and expanding its menu.
The FDA go-ahead marks Quidel's fourth MDx test to receive 510(k) clearance for the Solana platform.
The point-of-care test delivers results in 13 minutes or less and will be available for the 2016-2017 respiratory season.
The point-of-care test detects and distinguishes influenza A and B as well as respiratory syncytial virus in about 20 minutes.
Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.
The recent approvals underscore the usefulness of procalcitonin as a sepsis biomarker, even as newer molecular approaches to diagnosing the condition hit the market.
The technique aims to enable physicians to more precisely locate where to biopsy, and as a result patients would require fewer biopsies.
The device, the ORAcollectDx, is an alternative to buccal swabs and provides higher DNA yields, according to the firm.
In Science this week: genetic target for urothelial bladder cancer treatment, and more.
At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.
Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.
Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.