Founded in 2009, Pennsylvania-based AllSource Screening Solutions manufactures and distributes diagnostic testing products, with its roots in drug-screening kits developed through the owners’ staffing-agency work. The company now supplies testing products worldwide and has developed what it describes as the first FDA-cleared, OTC-approved and CLIA-waived fentanyl dip-card test in the United States. Its retail Drug Detector line extends that screening focus to at-home consumers and pharmacies.
FDA Cleared
FDA EUA Authorized
Compliance program
CLIA-Waived
Compliance program
OTC Approved
Compliance program
OTC Compliant
Compliance program
FDA
Quality certification
OTC
Quality certification
Intelligent Fingerprinting LtdFounded in 2007 from chemistry research at the University of East Anglia, Intelligent Fingerprinting develops and manufactures rapid workplace drug-screening systems that analyse sweat from the fingertips. Its Cambridge team makes the single-use screening cartridges in-house and pairs them with a portable reader, producing results in about ten minutes without collecting fingerprints or requiring specialist facilities. The company is now a wholly owned subsidiary of Intelligent Bio Solutions Inc. and serves more than 480 customers worldwide.New York, NY
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
Chembio Diagnostic Systems, IncChembio 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.MEDFORD, NY
Genus Lifesciences, IncFounded in 1999, Genus Lifesciences manufactures branded and generic pharmaceutical products and is headquartered in Allentown, Pennsylvania. It operates four FDA-inspected manufacturing and warehousing facilities in Allentown and performs clinical and non-clinical studies supporting FDA approval of marketed unapproved drugs.ALLENTOWN, PA