STDs
QuidelOrtho Nabs FDA 510(k) for Syphilis Assay
The Vitros syphilis test qualitatively determines total antibodies to Treponema pallidum-specific antigens in serum and plasma.
Top Five Articles on 360Dx Last Week: FDA Draft Guidance to Modify Devices; 510(k) Clearances; More
Last week, readers were most interested in a story about draft guidance from the FDA on modifying medical devices without needing another round of regulatory review.
FDA Grants First Authorization for Over-the-Counter Syphilis Test
NowDiagnostics' at-home test detects antibodies against Treponema pallidum in 15 minutes from blood samples.
Quest Diagnostics Study Finds Pregnant Women Undertested for Chlamydia, Gonorrhea
One-third of pregnant women who tested positive for chlamydia or gonorrhea were not retested before giving birth, the study found.
The Baltimore-based firm is developing multiplex molecular tests for sexually transmitted disease identification and drug susceptibility characterization.
Jan 31, 2024
Dec 20, 2023
Dec 15, 2023