For more than 20 years, Gold Standard Diagnostics Horsham has developed and manufactured rapid test systems for environmental, food and life-sciences testing. Formerly Abraxis, the Horsham operation became part of Eurofins Technologies in 2017 and adopted the Gold Standard Diagnostics name in 2022. Its U.S.-based scientific team develops customized assays and contract-manufacturing programs, serving customers directly or through distributors in more than 100 countries under ISO 9001:2015 and ISO 13485:2016-certified quality systems.
ISO 9001:2015
ISO 13485:2016
SAM Registration
Registration
USFCR Verified Vendor Seal
Compliance program
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
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
Randox LaboratoriesRandox Laboratories develops and manufactures in vitro diagnostic products and laboratory solutions, spanning quality-control materials, analysers, reagents and genomic services. With more than 40 years of experience, the company also provides contract manufacturing and companion-diagnostic support, serving customers through facilities and laboratories across the UK, Europe, Asia and the USA. Its proficiency-testing programmes reach more than 100,000 users in over 145 countries, while its manufacturing operations have capacity exceeding 10.5 million litres per year.KEARNEYSVILLE, WV