Chembio Diagnostic Systems, a Medford, New York subsidiary of Biosynex, develops and manufactures rapid point-of-care diagnostic tests for detecting and monitoring disease. Its proprietary Dual Path Platform (DPP®) technology supports simple tests that can use a small blood sample and deliver results in about 15 minutes, including the FDA-approved, CLIA-waived DPP® HIV-Syphilis test. Chembio serves clients worldwide through offices and partners and also applies its diagnostic platform to veterinary testing.
CLIA Waived
Compliance program
FDA Approved
CE Marked
USDA Licensed
FDA
Quality certification
OraSure Technologies, IncFounded in 1987 as SolarCare in Bethlehem, OraSure Technologies develops and manufactures non-invasive rapid diagnostic tests and biological-sample collection devices. Now headquartered in Bethlehem and publicly traded since 2000, the company is known for point-of-care testing that brings HIV, HCV and other infectious-disease results closer to patients, alongside DNA Genotek sample-management solutions for genomic and microbiome research. Its OraQuick platform includes the first FDA-approved, CLIA-waived rapid HCV test and an oral-fluid HIV self-test.325413BETHLEHEM, PA
First Diagnostic CorporationFirst Diagnostic Corporation develops rapid point-of-care diagnostic systems and helps other medical-device manufacturers bring diagnostic technologies to the U.S. healthcare market. Founded in 2004 as a medical-device manufacturer, the privately held company now combines its own rapid-test brands with sales representation, distribution, marketing, and customer support for partner manufacturers. Its eight-person operation maintains government and military program relationships and cites GMP and ISO 9001 quality standards.NEW YORK, NY
Prompt DiagnosticsBaltimore-based Prompt Diagnostics develops portable molecular diagnostic platforms that bring laboratory-quality PCR testing to the point of care, with results in under 20 minutes. Co-founded by biomedical engineer Alex Trick and Johns Hopkins professor Tza-Huei (Jeff) Wang, the company built its platform around magnetofluidic cartridge technology invented during Trick’s doctoral research. Prompt is applying that technology to infectious-disease testing, including work on HIV, syphilis, and drug-resistant gonorrhea in low-resource settings.BALTIMORE, MD
Accel Diagnostics, LLCAccel Diagnostics is a medical diagnostic company developing proprietary point-of-care diagnostic assays for the diagnosis, monitoring, and management of a wide variety of medical conditions. The company's patented platform technology transforms patient blood testing from lab-centered to near-patient, enabling lab-quality medical diagnostic tests anytime and anywhere.HOUSTON, TX