Empowered Diagnostics said on Tuesday that it has obtained CE marking for its CovClear COVID-19 Rapid Antigen Test and that the test will be available at doctors’ offices, pharmacies, and other point-of-care locations throughout the European Union.
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 and produces results within minutes, the firm said.
The firm said it developed CovClear for at-home testing and has a manufacturing capacity of 20 million tests per month. Its test has 98.5 percent sensitivity and 100 percent specificity, the company added.
Pompano Beach, Florida-based Empowered said that in the coming weeks it anticipates obtaining US Food and Drug Administration Emergency Use Authorization, and authorization in the UK and Canada, for CovClear. The company is seeking over-the-counter authorization from the FDA.
It has also developed the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, which measures levels of SARS-CoV-2 antibodies, Empowered said.