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Tetracore is a Maryland-based biotechnology research and development organization that creates innovative kits, assays, reagents, and instruments for detecting infectious diseases, biological warfare threat agents, and biological markers. The company's solutions have been used by various laboratorians, veterinarians, first responders, and clinicians, and the company maintains strong relationships with various government agencies and related industry partners.
Tetracore offers a broad range of highly-specific, rapid, antibody-based test kits and antibody reagents to detect biological warfare infectious agents and toxins, including the first FDA-cleared test kit for the identification of B. anthracis from colonies. Tetracore also offers a product line of real-time probe hydrolysis Polymerase Chain Reaction (PCR) reagents and kits for animal pathogens. In early 2020, Tetracore developed and commercialized a real-time PCR test and serology multiplex test for SARS-CoV-2 (COVID-19).
In 2011, the company piloted an orthopoxvirus detection protocol called the Tetracore Orthopox BioThreat® antigen detection assay. The Tetracore Orthopox Biothreat Alert can be used to test for monkeypox. The test detects active monkeypox disease from a skin lesion and can be performed at room temperature, and does not require special training. Tetracore is now developing a rapid antigen test for monkeypox.
- FDA Certified – Registration # 3003517954.
- USDA Veterinary Biologics Establishment License #644.
- BSL3 registered with CDC and DOJ to possess and work with select agents.
- CDC FSAP (Federal Select Agent Program) Registration #: 20200709-161731.
- Office for Human Research Protections U.S. Department of Health and Human Services IRB00013052 Tetracore, Inc IRB #1.
- Federal wide Assurance (FWA) number assigned by the Office for Human Research Protections (OHRP) for Tetracore, Inc, is FWA00031080.
Tetracore was founded in 1998 by former United Nations special commission biological weapons inspectors and scientists of the Naval Medical Research Institute in Bethesda, Maryland. Founders include the CEO William Nelson, Thomas W. O'Brien, Gary W. Long, and Beverly L. Mangold.