The rule makes explicit that LDTs are in vitro diagnostics and as such are subject to oversight by FDA under the Federal Food ...

In a BioMérieux-sponsored symposium, economist Lord Jim O'Neill revisited a 2016 report on AMR while experts discussed the use of rapid testing tools such as those offered by the French company.

The companies began working together on the digital pathology offering, which combines technology from each, in late 2019.

The test is a cell-based neutralizing antibody assay that detects preexisting anti-AAVRh74var antibodies that could impact patient safety or the efficacy of treatment.

DeepUll showcased its UllCore platform and UllCore BSI Test, a one-hour multiplex PCR assay targeting 95 percent of ...

The new test joins Abbott's existing portfolio of laboratory-based tests that utilize the same neurology biomarkers.

The cases could overturn a legal principle known as the "Chevron doctrine" under which courts have typically deferred to ...

Though COVID test sales were behind the decline in revenues, the firm expects there won’t be any further material impact on its sales from such tests.

The system can perform automated phenotypic antimicrobial susceptibility testing and minimum inhibitory concentration analysis in approximately 24 hours.

Mediford will provide access to C2N's Biopharma Clinical Research Services, which offers mass spec-based assays for analytes linked to human neurological diseases.

Mediford will provide access to C2N's Biopharma Clinical Research Services, which offer mass spec-based assays for analytes linked to human neurological diseases.

The FDA's new quality system rules will be aligned with the ISO 13485 standard starting in early 2026, raising alarm bells, ...