Amarex Achieves U.S. FDA EUA Approval for Client’s IVD for the Detection of SARS-CoV-2 Virus
Germantown, MD, USA (May 15, 2020) – On May 11, Amarex Clinical Research, LLC, an NSF International company, achieved approval from the U.S. FDA on behalf of its client, 1drop Inc., for an emergency use authorization (EUA) of an in-vitro diagnostic for the detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). The product, 1copyTM COVID-19 qPCR Multi Kit, is a highly sensitive assay with a short test result time of less than two hours. Developed by 1drop Inc., a Korea-based biotechnology company, this product is already approved in several countries, including South Korea, Sri Lanka, Germany, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.
1drop was introduced to Amarex by the Korean Innovation Center of Washington D.C. in the last week of March and Amarex was able to begin work on the EUA request in the first week of April. Amarex’s Regulatory Affairs department worked closely with the U.S. FDA and under rushed conditions to achieve rapid approval. After the authorization, the U.S. FDA emailed Amarex, “We appreciate your collaboration during the review and authorization process.”
Amarex’s President & CEO, Dr. Kazem Kazempour stated, “We appreciate the collaboration with 1drop Inc. on this important approval and the great responsiveness of the FDA reviewers. Laboratories will have immediate access to this kit, which will add to the safety of the gradual re-starting of those parts of the U.S. economy that have been in suspension.”
Amarex has achieved emergency approval for several other device, diagnostic and therapeutic products, and is working on approvals for additional products.
About 1drop Inc.
1drop Inc. develops world-class healthcare products and services using the best science and technology for the benefit of human health.
Mr. Jeong-in Bag, Sales Director
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International company, is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexus.com.
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