NEW YORK – Waters said Wednesday that it has received US Food and Drug Administration 510(k) approval for its automated BD Bactec FXI Culture System. According to Waters, clinical study data shows ...

NEW YORK – Tempus on Wednesday said that it is making its Paige Image Management System (IMS) open source for members of a newly formed digital pathology consortium, with Yale New Haven Hospital and ...

The test's new AI component is meant to help identify men who are at risk of having the severity of their tumor upgraded at ...

Under the agreement, NDT has an exclusive worldwide license for diagnostic use of a panel of nine antibodies to different tau protein forms.

The companies will initially offer C2N's PrecivityAD test in Argentina, Chile, Colombia, Dominican Republic, Ecuador, Jamaica, Mexico, Uruguay, and Venezuela.

The tissue-based next-generation sequencing assay analyzes 324 genes as well as genomic signatures including microsatellite instability and tumor mutational burden.

Proceeds will go toward obtaining US Food and Drug Administration approval for its products, for research and development work, and for general corporate purposes.

NEW YORK – Roche subsidiary Foundation Medicine announced on Tuesday that its FoundationOne CDx assay has received US Food and Drug Administration approval for use as a companion diagnostic with Roche ...

NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...

The guidelines now include Guardant's blood-based test Shield and Freenome's SimpleScreen, along with Geneoscopy's stool-based ColoSense assay and Abbott's Cologuard Plus assay.