The plaintiffs allege that Natera engaged in false and misleading advertising and marketing of its preimplantation genetic test for aneuploidy.

The company will conduct a prospective, multicenter study enrolling approximately 954 men with elevated PSA levels who are scheduled for a prostate biopsy.

The Germany-based company is developing a handheld infectious disease testing platform that does not require electricity.

The agency cleared more than a dozen assays and instruments for microbiology, molecular biology, clinical chemistry, and other testing.

The guidelines state that a test must be FDA-approved, personalized, tumor-informed, multiplex, and use PCR-NGS for ctDNA.

NEW YORK – Alzheimer's diagnostic company Alzpath announced on Wednesday that it has signed a global licensing agreement with Abbott to develop blood-based tests for Alzheimer's disease. Financial and ...

Last week, readers were most interested in a story about an allegation that Invitae illegally shared patients' genetic data.

NEW YORK – French oncology diagnostics company Spotlight Medical announced on Tuesday that its MyStage Dx assay for breast cancer has received CE marking under Europe's In Vitro Diagnostic Regulation.

NEW YORK – In a decision handed down on Tuesday by the US District Court for the District of Delaware, Guardant Health dodged trebled damages in a patent infringement case involving TwinStrand ...

NEW YORK – NeoGenomics said Monday after the close of markets that it has begun a private offering of $275 million of convertible senior notes. The company said it plans to use proceeds from the ...

Sysmex has launched its HISCL instrument and two blood-based Alzheimer's disease biomarker tests in Europe. The p-Tau217 test and Aβ42/40 ratio assay are research-use-only and CE-IVD marked. The tests ...