The molecular test detects and differentiates Bordetella pertussis and Bordetella parapertussis from fresh and frozen nasopharyngeal swab samples.
The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
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 test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
In order to be eligible for the drug, patients must have NTRK fusions, which may be determined via various tests including NGS and FISH.
The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.
The fully automated system has 12 independent thermal cyclers and runs the firm's diagnostic kits, but it can also operate as an open instrument.
An artificial intelligence-based analysis suggests a third group of ancient hominins likely interbred with human ancestors, according to Popular Mechanics.
In Science this week: reduction in bee phylogenetic diversity, and more.
The New York Times Magazine looks into paleogenomics and how it is revising what's know about human history, but also possibly ignoring lessons learned by archaeologists.
The Economist reports on Synthorx's efforts to use expanded DNA bases they generated to develop a new cancer drug.