Genomtec S.A. — Regulatory Filings 2021

May 17, 2021

Market authorisation for sales of Genomtec® SARS-CoV-2 EvaGreen®Direct-RT-LAMP CE-IVD Kit.The Management Board of Genomtec S.A.("Company", "Issuer") registered in Wroclaw, Poland, hereby informs thatafter expiry of the legislative deadline prerequisite when registering anew medical device for in-vitro diagnostic at the Office forRegistration of Medicinal Products, Medical Devices and BiocidalProducts, Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kitdiagnostic test has been granted full market authorisation for sales inthe European Union.The new product of the Issuer is a CE-IVDlaboratory kit constituting of assay controls and reagents forstreamlined isolation, reverse transcription and amplification ofnucleic acid utilizing the Reverse Transcription Loop-MedicatedIsothermal Amplification (RT-LAMP) reaction for SARS-CoV-2 virusdetection. The product, while maintaining the high level of diagnosticparameters, exhibits additional two very distinguishable and importantfeatures. Firstly, it enables biological material collection in a formof a native saliva sample, which is a non-invasive method for thepatient, as oppose to throat or nasopharyngeal swab collection, and doesnot require presence of a specialist personnel, simultaneously reducingpersonnel's exposure to virus contraction.Secondly,utilization of a special buffer prevents conducting a full geneticmaterial isolation from a sample in this test, which decreases the timeneeded to perform the entire diagnostic procedure by almost 60% andsignificantly lowers the cost of the entire diagnostic process.Thedevelopment of new products in the field of in-vitro diagnostics is oneof the key elements of the Issuer's strategy, thereby confirming itscompetency and high level of know-how. The commercial launch of a newproduct may also have a significant impact on the Issuer's economicactivity and generated revenue. For these reasons, in the opinion of theManagement Board, this information meets the criteria of confidentialinformation within the meaning of Art. 7 sec. 1 MAR.