Founded 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.
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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
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
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD
Novel Microdevices, IncBaltimore-based Novel Microdevices develops portable, sample-to-answer molecular diagnostic systems built around disposable microfluidic cartridges. Its battery-powered Novel Dx platform is designed to deliver lab-quality PCR results in about 15 minutes, including testing for respiratory infections and other diseases at the point of care. The company is establishing a GMP-compliant pilot manufacturing facility at its Baltimore headquarters to scale cartridge production.BALTIMORE, MD