Genetic Signatures CE-IVD approval now received for EasyScreen™ SARS-CoV-2 Detection Kit
By Genetic Signatures | Apr 1, 2020
Genetic Signatures are pleased to advise that our application for CE-IVD registration of our EasyScreen™ SARS-CoV-2 Detection Kit was granted overnight (Tuesday 31st March 2020).
This allows the kit to be marketed freely in the European Union, and the customers whose kits were already shipped to Europe can start testing once they have finished setting up their hardware.
Genetic Signatures are in advanced discussions with potential customers in Germany, UK, and Spain, to help ease the Global test shortage they are experiencing which is compounded by flight restrictions.
An application for TGA registration was also lodged at the same time, and this clearance is anticipated in the coming weeks. The new kits use Genetic Signatures 3base™ technology which simplifies the detection regime by reducing sequence variation.