Additionally, the agency would require non-invasive tests to be authorized by the FDA as well as a post-approval study to maintain continued coverage.

The company's BV Flex test measures patient immune proteins in capillary blood samples to determine whether an individual has a bacterial or viral infection.

The initiative now includes Foundation Medicine's FoundationOne Liquid CDx assay to test new therapy combinations in select groups of adults and children with cancer.

The company received $441,437 from the foundation to miniaturize its molecular point-of-care test for HIV viral load.

While many advocate that oversight of AI analyses of lab data be handled through CLIA, some stakeholders say that FDA should play a role.

The company said it will use the funds to develop its robotic phlebotomy device, including preparing for a US Food and Drug Administration de novo submission.

Last week, readers were most interested in a story about Dxcover's platform, which integrates infrared spectroscopy with proprietary algorithms, receiving Class C certification.

The test measures plasma amyloid beta and phosphorylated tau 217 to determine the likelihood that a person has the brain amyloid pathology characteristic of Alzheimer's disease.

Beckman Coulter will use the platform to unify data across its instruments and systems to provide standardized performance metrics and AI-based analytics.

While many advocate that oversight of AI analyses of lab data be handled through CLIA, some stakeholders say that FDA should play a role. The AccuPower HIV-1 Quant Kit has been designed for use on the ...

A parallel deal between Lucence, DxD Hub, and the Brain Tumour Society Singapore aims to include patient perspectives in the research and development process. Adidtxt noted Ignite's proteomics-based ...