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 Diagnostics
Empowered 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.
Media Contact:
Emily
Greifeld
RF|Binder
emily.greifeld@rfbinder.com
212-994-7633