Long term potential is huge
Therma Bright receives CE certification for AcuVid
2021-04-19 08:20 PT - News Release
Mr. Rob Fia reports
THERMA BRIGHT ANNOUNCES EU-CE APPROVAL FOR ACUVID(TM) COVID-19 RAPID ANTIGEN SALIVA TEST AND CONDITIONAL SALE FOR 100,000 CE-ONLY ACUVID(TM) TEST KITS
Therma Bright Inc. has received CE approval certification from an EU competent authority of Belgium for its AcuVid COVID-19 rapid antigen saliva test, and has secured a conditional purchase order for 100,000 units through a new global distribution partner, McWilliams Collective.
EU-CE Approval: The EU-CE approval enables Therma Bright to distribute throughout 27 member states that make up the European Union. EU & EEA Member countries that have a combined population of 446,824,564. According to the European Centre for Disease Prevention and Control, as of the 1st week of April over 26.3 million cases have been reported in the EU/EEA since the global pandemic began. The EU declaration of conformity indicates that the AcuVid COVID-19 Rapid Antigen Saliva Test complies with all the requirements of European IVDD (in-vitro diagnostic device) legislation.
According to EU recommendations, timely and accurate COVID-19 testing is an essential part of the management of COVID-19 for slowing down the spread of the virus, supporting decisions on infection control strategies, patient management at healthcare facilities, and detecting asymptomatic cases that could spread the virus further if not isolated.
"The CE regulatory approval is a huge win for Therma Bright and our AcuVid COVID-19 Rapid Antigen Saliva Test. This gives our Company immediate access to the large population of citizens across the European Union," explained Rob Fia, CEO of Therma Bright. "Securing CE approval also gives us access to the UK market and the recommendation by the European Commission favorably positions our innovative 15-minute rapid antigen saliva test to meet the tremendous demand for reliable, accurate and user-friendly tests. We are extremely pleased to partner with the team at McWilliams Collective for this initial 100,000-unit order for the European market, which we expect will be the start of great business relationship."