Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
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 test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.
The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.
The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.
The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.
The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.
The Hill reports President Donald Trump issued an executive directing federal agencies to cut the number of board and advisory committees they have.
The New York Times reports that researchers are combining tools to more quickly develop crops to feed a growing population and cope with shifting climates.
Scientists in Canada are looking to the UK's plan to sequence children with rare conditions for inspiration, the National Post reports.
In PNAS this week: copy number changes arose during polar bear evolution, genomic and transcriptomic analysis of the Siberian hamster, and more.