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FDA clearance

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.

The ID Core XT is the second molecular assay approved by the FDA for use in transfusion medicine and the first to report genotypes as final results.

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.

The FDA granted the assay's status based on its ability to detect both ovarian and pancreatic cancer in asymptomatic individuals over the age of 65.

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Google's Project Nightingale has collected health information on millions of Americans, according to the Wall Street Journal.

An opinion piece at The Hill criticizes the proposed plan to collect DNA samples from migrants at the US border.

Nature News writes that women in chemistry are less likely to have their manuscripts accepted for publication.

In PNAS this week: tRNA fragment signature for chronic lymphocytic leukemia, genomic sites sensitive to ultraviolet radiation in melanocytes, and more.