Orfila Diagnostics Inc.

Orfila Diagnostics Inc., operating as nform, develops rapid oral fluid drug screening tests that meet US DOT laboratory screening standards for sensitivity and specificity. Founded in 2021, the company manufactures proprietary rapid diagnostic tests for detection of drugs in oral fluid specimens. The product portfolio includes nform THC (marijuana screening at 4 ng/mL cutoff with 97.9% accuracy and 10-fold greater sensitivity than competing visual-read oral fluid tests) and nform 7 (7-drug workplace panel detecting 6-acetylmorphine, amphetamine, cocaine, methamphetamine, opiates, oxycodone, and PCP with cutoffs aligned to US DOT requirements). All tests are visually read with no instrumentation required and support single-specimen collection for both screening and confirmation testing. Key differentiators include untreated cotton collection pads, integrated stabilizing buffer systems, and observed specimen collection processes suitable for on-site administration by any trained user with results delivered in 10 minutes. Products are available for employment and insurance use in the United States and for employment use in Canada. The company maintains R&D and manufacturing operations in Newport, Delaware, with all products manufactured in the USA. Leadership includes Michael Vincent (CEO, 30+ years toxicology/diagnostics), Martin Gould (CTO, 40+ years diagnostic experience, lateral flow immunoassay pioneer), and Christopher Tarpey (CCO, 20+ years in-vitro diagnostics, former Abbott Toxicology Business Unit head).