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.

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

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.

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.

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 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.