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FDA clearance

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.

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The US National Institutes of Health's All of Us project awarded $4.6 million to the company Color to develop a genetic counseling resource for the program.

New guidelines say that more women may benefit from genetic testing for hereditary breast or ovarian cancer, according to the Los Angeles Times.

The Times of India reports on a pilot study that used genomic testing to determine whether patients had drug-resistant tuberculosis.

In Cell this week: small proteins identified among human microbiome, role for tumor microbes in pancreatic cancer survival, and more.