NEW YORK – In February, the US Food and Drug Administration granted 510(k) clearance to a dozen in vitro diagnostic tests encompassing molecular, immunoassay, clinical chemistry, and ion selective ...

The research team created a point-of-care assay that can detect bacterial STIs, including chlamydia and gonorrhea.

In a statement, the firm's President and CEO Zhenya Lindgardt noted that in 2025 Sera pivoted from clinical validation to commercial operation.

S, progesterone, 17-hydroxyprogesterone and androstenedione, and run on Roche's cobas i 601 mass spectrometer.

Altai Capital Management has demanded the appointment of two Altai candidates to OraSure's board and urged a strategic review and possible company sale.

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.

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.

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.