POMPANO BEACH, Fla., April 20, 2021 /PRNewswire/ — Empowered Diagnostics LLC, one of the largest U.S.-based manufacturers of rapid diagnostic testing solutions, announced today that it received CE marking for its CovClear™ COVID-19 Rapid Antigen Test.
CovClear is a lower-cavity nasal swab test that can detect active COVID-19 infection within about two days of exposure to SARS-CoV-2, before a person becomes contagious. The test produces highly accurate results within minutes, and is quick, comfortable and simple to use. It has been researched, developed and manufactured in the U.S., and is produced using the highest quality materials available.
“We are empowering people worldwide with the knowledge and confidence to understand their health,” said Barry Abraham, President of Empowered Diagnostics. “CovClear receiving a CE mark is an important step in delivering access to extremely accurate, affordable rapid testing throughout the European Union. We are proud to lead the global effort in raising the bar for high-sensitivity diagnostic tests.”
CovClear has 99.7% accuracy, 98.5% sensitivity and 100% specificity.
“Highly sensitive tests are essential for preventing the spread of COVID-19 by minimizing false negatives and, therefore, the false confidence delays that discourage people from re-testing,” Abraham said.
With a manufacturing capacity of 20 million tests per month, Empowered Diagnostics is uniquely equipped to deliver critically needed tests worldwide. In addition to CovClear, the company developed the ImmunoPass™ COVID-19 Neutralizing Antibody Rapid Test, which measures levels of virus-neutralizing antibodies that indicate immunity.
CovClear was developed and engineered for at-home testing. FDA Emergency Use Authorization, in addition to authorization in the United Kingdom and Canada, is anticipated in the coming weeks. Empowered Diagnostics is working closely with the FDA to secure over-the-counter designation for CovClear. Tests are currently used in the U.S. for corporate surveillance and self-screening programs, ensuring that employees remain safe and healthy as they head back to the office. The CovClear test will be available at doctors’ offices, pharmacies and other point-of-care locations throughout the European Union.
About Empowered DiagnosticsEmpowered Diagnostics delivers innovative, best-in-class diagnostic tests backed by leading experts in healthcare and biotechnology. Our mission is to empower people with the knowledge and confidence to understand their health through reliable, affordable, high-quality tests. Based in Pompano Beach, Florida, Empowered Diagnostics is one of the largest U.S.-based manufacturers of rapid diagnostic solutions.
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