For more than 20 years, Rockville-based Tetracore, Inc. has developed diagnostic reagents, assays, and instruments that detect infectious diseases and biothreat agents. Its work spans human and animal health, domestic preparedness, and forensic biology, including the T-COR 8 portable PCR thermocycler and the BioThreat Alert testing platform. Tetracore’s quality system is certified to ISO 13485 and ISO 9001, with laboratories accredited to ISO/IEC 17025.
ISO 13485 & EN ISO 13485 Certified — Certificate MD 787351
ISO 9001 Certified — Certificate FM 752267
ISO/IEC 17025:2017 Accredited — Chemical and Biological Testing, Certificate L26-263
ISO/IEC 17025:2017 Accredited — Forensic Testing, Certificate 7445.01
Maryland Forensic Laboratory License for DNA Analysis — License FL0242
Registration
FDA Registration — Registration 3003517954
Registration
USDA Veterinary Biologics Establishment License — License 644
Registration
BSL-3 Registration with CDC and DOJ for Select Agents
Compliance program
CDC Federal Select Agent Program Registration — 20230105-102953
Registration
OHRP Institutional Review Board Registration — IRB00013052
Registration
Federalwide Assurance — FWA00031080
Registration
FDA Quality System Regulations, 21 CFR Part 820
Compliance program
Current Good Manufacturing Practice (cGMP) Compliance
Compliance program
USDA Regulations, 9 CFR Compliance for Animal Health Diagnostics
Compliance program
ISO17025
Quality certification
FDA
Quality certification
FDAQSR
Quality certification
USDA9CFR
Quality certification
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
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
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