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 test identifies patients with positive homologous recombination deficiency (HRD) status who may benefit from GSK's PARP inhibitor Zejula. The CDx will combine GenDx's HLA typing kits and NGSengine ...

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.