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New U.S. FDA Testing Guidance for COVID-19 Detection Assays as of May 11, 2020

Germantown, MD, USA (May 12, 2020) – On May 11, the U.S. FDA updated the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. In the revised policy, the U.S. FDA recommends that all diagnostic manufacturers and testing labs conduct their SARS-CoV-2 assay validation using SARS-CoV-2 positive and negative clinical specimens (30 positives/30 negatives), in preference to the previously accepted ‘contrived’ test specimens.

Assays submitted to the FDA prior to May 6, 2020 may obtain conditional approval, then follow-up with a post-market validation study with clinical specimens within four months of the FDA’s Letter of Authorization, unless otherwise agreed to with DMD/OHT7-OIR/OPEQ/CDRH.

Assays, including EUAs, submitted after May 6, 2020 will likely be required to have the clinical validation data included in the application.

Assays already approved using ‘contrived’ specimens are likely to be required to re-validate with clinical testing specimens.

Amarex’s President & CEO, Dr. Kazem Kazempour, noted, “From the outset, our team has worked diligently to stay informed of ever-changing regulatory procedures surrounding COVID-19 clinical trials and approvals. Our organization was designed to offer streamlined clinical trial services, balancing speed and safety, and we are well matched to meet the demands for accelerated and compressed clinical trial trajectories that are changing frequently during the current COVID-19 pandemic. We offer our experience and understanding of the challenges and opportunities associated with COVID-19 product development and we can help clients navigate these changes.”

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.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com

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