Remuneration Information • Feb 14, 2022
Remuneration Information
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Commencementof comparative researchThe Management Board ofGenomtec S.A. based in Wrocław (_quot;Issuer_quot;, _quot;Company_quot;) hereby announcesthat the Company signed agreements with two Polish medical centers andCRO (Contract Research Organization) company based in France, providingprofessional services in conducting comparative testing and clinicalstudies ("Agreements"). The tests will be conducted on Genomtec IDdevices. The results obtained in the study will be the basis forregistration of Genomtec_#174;ID platform and Respiratory Panel (RP) 5-plexassay for CE-marking within the European Union planned for the middle ofthis year. The study has a multi-center character and will be conductedin Poland and France across a network of medical clinics, clinicallaboratories and hospital settings.The aim of the comparativestudy is to evaluate the performance of the Genomtec_#174;ID diagnosticplatform and the RP 5-plex test for the detection of viral and bacterialreasons causing respiratory infections. The RP 5-plex panel identifies 5pathogens: Influenza A/B, RSV, SARS-CoV-2, M.pneumoniae and C.pneumoniaesimultaneously in one single test. The results of these tests will becompared with reference methods of Real-Time (RT)-PCR to establishperformance characteristics of the Genomtec_#174;ID solution and use the datanecessary for registration as a medical device for in-vitro diagnostics,in accordance with Directive 98/79/EC (IVD) in the European Union whatthe Company wants to achieve in the middle of this year.Totalremuneration under the Agreements, due to Polish medical centres and theFrench CRO, does not exceed 20% of the Company's balance sheet totalvalue and may be further clarified upon receipt of the final studyreport. Statistical analysis of survey data under the Agreement will beconducted on samples collected in Poland and France. The Agreements andthe remuneration specified therein include, inter alia, such elements as:-Collectionof clinical samples from patients and their biobanking (where needed);-Executionof a medical IVD diagnostic experiment on retrospective as well asprospective samples according to the Clinical investigation plan(experimental testing is carried onto the Genomtec_#174; ID Diagnosticplatform, whereas reference testing is carried out in the CentralLaboratory);-Manage and monitor the activities of the clinical sites;-Statisticalanalysis for technical file;-Report generation and documentation forproduct registration of the reaction card and the analyzer - in theterritory of the European Union in accordance with the requirements ofDirective 98 98/79/EC of the European Parliament and the Council - IVDD.Thecommencement of comparative research is an important stage in theIssuer's key project and is a condition for the market authorization ofthe Company's flagship product therefore, in the opinion of theManagement Board, this information meets the criteria of confidentialinformation within the meaning of Article 17(1) MAR.
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