The US Food and Drug Administration granted clearances for infectious disease tests, digital pathology software, and hematology analyzers, among other in vitro diagnostic technologies.

The rapid lateral flow assay from Lumos Diagnostics distinguishes bacterial and nonbacterial respiratory infections using a drop of blood.

The agency said that the test is unnecessary for the screening of whole blood and blood components that are screened with nucleic acid tests and core antigen tests.

The Determine Antenatal Care Panel is used for the simultaneous detection of infectious diseases that threaten maternal and pediatric health.

The partnership will initially focus on low-abundance biomarkers supporting translational research in Alzheimer's disease.

NEW YORK – QuidelOrtho announced Monday an integration deal making fecal biomarker testing from Bühlmann Laboratories available on QuidelOrtho's Vitros system. The Bühlmann fecal tests detect ...

The company's next-generation sequencing-based test is used to aid the detection of cancers in patients with indeterminate ...

Last week, readers were most interested in a story about an extended collaboration between Personalis and Tempus to include colorectal cancer.

NEW YORK – Supported by a recent $4 million seed round, Chicago-based startup company OrisDx is preparing to bring to market this year a saliva-based test to aid the detection of oral cancers in ...

Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...