Genomtec has started pilot production of analyzers for the first 15 Genomtec ID devices, the company said. They will be used in comparative clinical trials, the results of which will be used to register Genomtec ID as a medical device for in-vitro diagnostics under the IVD Directive in the European Union in the first half of this year.
“I am proud that our team successfully completed the design and testing work and that it was able to place all the necessary elements in such a small space that would enable genetic diagnosis of infections. The analyzer is a small and light device with dimensions of 16.5 cm by 11.5 cm and a height of 11 cm. It fits in the hand and means that we can carry it without restrictions wherever and whenever we want. Such small dimensions have been achieved thanks to our patented non-contact heating technique using light, as well as thanks to the use of the latest technologies in the field of electronics and mechanics, ”said the president and co-founder Miron Tokarski, quoted in the material.
The analyzers are manufactured by the Genomtec team in Great Britain in close cooperation with the local CDMO partner.