Now Diagnostics
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.
The company is seeking FDA de novo classification for the screening test, which is a capillary, blood-based lateral flow immunoassay.
NowDx Raises $22.5M in Series B Funding Round
The company plans to use the funds to develop at-home diagnostics, including its OTC syphilis test, which is undergoing de novo review by the US Food and Drug Administration.
FDA Grants Emergency Use Authorizations for SARS-CoV-2 Tests From Harvard, NowDiagnostics
Harvard's RT-PCR-based test can be used with self-collected nasal samples, while NowDiagnostics' immunoassay can be used with fingerstick blood samples.
BARDA Awards NowDiagnostics $696K for Development of COVID-19 Home-Use Antibody Test
The firm said that in addition to home use, its test for SARS-CoV-2 antibodies could be used in clinics and hospital emergency rooms.