Stakeholders suggested that while the FDA rule is dead, updates to LDT regulation are coming nonetheless, and the industry should play a lead role in developing them.

Danaher subsidiaries Beckman Coulter, Cepheid, and Leica Biosystems will be working together with external partners to focus on existing disease areas.

The new BD Onclarity HPV test would enable patients to collect a sample without the need for liquids or other devices and mail it to the laboratory for testing.

Danaher subsidiaries Beckman Coulter, Cepheid, and Leica Biosystems will be working together with external partners to focus on existing disease areas.

The company reported 5 percent growth in Europe and 3 percent growth in North America, while its revenues in the rest of the world dipped 2 percent.

The development marks a shift up the value chain for labs and could prove a meaningful revenue stream for providers able to ...

China's volume-based procurement policy and US tariffs have forced companies with large business in China to reset their ...

Through clinical trials, partnerships, and economic studies, a crop of test developers is trying to prove the value of their ...

Some experts believe a technological tipping point is imminent, if not already here, but adoption of point-of-care MDx has ...

The funding supports development of an assay to detect and differentiate H5 influenza A from seasonal H1 and H3 subtypes, flu B, and COVID-19.

Diagnostics revenue totaled €1.06 billion in Q3 compared to €1.11 billion a year ago, down 4 percent or a fraction of a percent on an adjusted basis.