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

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

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.

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

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

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 ...

NEW YORK – ClearNote Health said Wednesday that it has received UK Conformity Assessed marking for its blood test for early-stage pancreatic cancer. The San Diego-based firm's Avantect Pancreatic ...

NEW YORK – VieCure said Thursday that it has entered a strategic partnership with cancer genomic testing firm Guardant Health to embed Guardant's menu of precision oncology tests into the VieCure Halo ...