- MedMira (TSXV:MIR) has completed the CE mark registration process for its REVEALCOVID-19 Total Antibody Test
- The mark declares conformity with all the necessary requirements stated in the In Vitro Diagnostic Medical Devices Directive of the European Parliament
- As such, the REVEALCOVID-19 test is now registered in Germany’s DIMDI data base
- The test is also under review by the Food and Drug Administration in the US
- MedMira (MIR) is currently up 31.48 per cent and is trading at C$0.36 per share, with a market cap of $233.72 million
MedMira (TSXV:MIR) has completed the CE mark registration process for its REVEALCOVID-19 Total Antibody Test.
Based in Nova Scotia, the company develops and manufactures a range of rapid diagnostic tests for hospitals, laboratories, clinics and individuals. These products are sold around the world under its Reveal, Multiplo and Miriad brands.
With the CE marking now complete, the REVEALCOVID-19 Total Antibody Test is declared to conform with all the necessary requirements designated by the In Vitro Diagnostic Medical Devices Directives of the European Parliament.
A certificate stating this has also been received, and the test is now registered in Germany’s DIMDI data base.
Hermes Chan, CEO of MedMira, said the CE marking represents a significant milestone for the company.
“Our RVF-based total antibody test will provide immediate information to physicians and healthcare providers to assess the total antibody status in patients who have been infected with the SARS-CoV-2 virus, the virus that causes COVID-19.
“Additionally, the unique batch testing capability of the REVEALCOVID-19 Total Antibody Test would be ideal for the increasing demand for a large screening program developed in many countries,” he said.
MedMira also noted that the REVEALCOVID-19 test is currently under review by the Food and Drug Administration in the US for Emergency Use Authorisation.
The company made its EUA submission earlier this month, based on guidelines presented by the FDA.
While it’s still unknown as to how long this process will take, MedMira confirmed its intentions to meet all the necessary requirements in a timely manner.
MedMira (MIR) is currently up 31.48 per cent and is trading at C$0.36 per share at 1:28pm EDT.