On May 20, TestGene received the European CE certificate of conformity for the developed genetic test “CoV-2-Test”, which detects COVID-19 coronavirus infection by real-time RT-PCR.
This certificate confirms that the company’s medical device meets the requirements of the European Union. The CE mark is valid throughout the European Union and allows for the free trade of products within the EU.
According to TestGene CEO Andrey Toropovsky, the CE mark is another confirmation of the high quality of medical products produced by the company.
“Our production facilities allow us to produce up to 50 thousand tests per day, and in the future — up to 2 million per month. I am confident that our company will make a worthy contribution to help combat the pandemic by offering the world community, along with existing analogues, a high-quality, high-precision diagnostic kit”, said Andrey Toropovsky.
TestGene also has European CE marks for test-systems to identify fetal sex using maternal blood early in pregnancy and for early detection of prostate cancer. These test-systems are supplied to the near and far-abroad countries.
The European Union consists of 27 countries: Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Finland, Germany, Greece, Hungary, Ireland, Italy,Luxembourg, Latvia, Lithuania, Malta, the Netherlands, Portugal, Poland, Romania, Slovenia, Slovakia, Spain, and Sweden.