The test allows for quantitative measurement of the protein neurofilament light chain – a marker of neuroaxonal injury – in plasma and serum.

Last week, readers were most interested in a story about AltraTech moving its HIV viral load test moving toward commercialization with the help of a Gates Foundation grant.

The Elecsys ApoE4 immunoassay detects genetic variants associated with an increased risk of late-onset Alzheimer's disease using a blood sample.

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 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 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 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.

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