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

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

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

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

NEW YORK – ClearNote Health said on 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 ...

The UK government said that it plans this year to repeal regulations specific to COVID-19 tests as part of the alignment with EU Common Specifications.