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

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 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 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.

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.

The system consists of a microfluidic cartridge with 640 incubation wells that allows the platform to visually test all clinically relevant antibiotics quantitatively.

The firm expects to reach patients who might otherwise avoid medical appointments by offering screening tests through dentists.

The Phase II study will evaluate CytoDyn's leronlimab in combination with TAS-102 and bevacizumab in patients with relapsed or refractory metastatic colorectal cancer.

The Irvine, California-based company will now market its test to clinical labs throughout the UK for patient testing.

Life Line aims to offer Lucent's blood-based testing through its mobile delivery model at urban and rural community health screening events.