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.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
A Harvard University professor has been charged with making false claims regarding funds he received from China, the New York Times reports.
Discover magazine reports that animal dissections might dissuade students from science careers, but that a firm has developed synthetic frogs for dissections.
Nature News reports that a US panel is reviewing current guidelines for federally funded gain-of-function viral research.
In PNAS this week: de novo mutation patterns among the Amish, an alternative RNA-seq method, and more.