The companies intend to reduce variability and rework by aligning high-quality slide preparation with reliable digitization.
The research team created a point-of-care assay that can detect bacterial STIs, including chlamydia and gonorrhea.
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 electrode ...
S, progesterone, 17-hydroxyprogesterone and androstenedione, and run on Roche's cobas i 601 mass spectrometer.
In a statement, the firm's President and CEO Zhenya Lindgardt noted that in 2025 Sera pivoted from clinical validation to commercial operation.
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.
NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...
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.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results