Founded in 1996 by general surgeon Dr. Schreiber, Chestertown’s privately owned Aerscher Diagnostics makes HemaPrompt, a guaiac-based occult blood test with its developer built into the card. Its HemaPrompt FG product handles both fecal and gastric specimens, and the company supplies clinics and hospitals across the United States with training materials and direct support.
CLIA-waived
Compliance program
FDA cleared
Registration
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
AllSource Screening SolutionsFounded 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.325413EXPORT, PA
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
SeraCareSince the early 1980s, SeraCare has supported the diagnostic testing industry with biological materials that help laboratories and assay developers establish confidence in their results. The Milford-based company is known for patient-like reference materials used in emerging clinical genomics applications, while its ISO 13485-certified, cGMP-compliant facilities provide traceability from sourcing through delivery.IJAMSVILLE, MD