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Genomtec S.A.

Regulatory Filings Jun 8, 2022

5621_rns_2022-06-08_ba689afe-8ab9-4e09-90c9-7d47762bddad.html

Regulatory Filings

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Marketauthorisation for sales of Genomtec_#174; IDTheManagement Board of Genomtec S.A. ("Company", "Issuer") registered inWroclaw, Poland, hereby informs that after expiry of the legislativedeadline prerequisite when registering a new medical device for in-vitrodiagnostic use at the Office for Registration of Medicinal Products,Medical Devices and Biocidal Products, Genomtec_#174; ID Respiratory Panel 5- Plex has been granted full market authorisation for sales in theEuropean Union.Genomtec_#174; ID Respiratory Panel 5 - Plex is anautomated, genetic in-vitro diagnostic test utilizing a microfluidicreaction card along with the patented isothermal nucleic acidamplification method SNAAT_#174; combined with proprietary assays integratedon the card to detect SARS-CoV-2 virus, respiratory syncytial virusestypes A and B, Influenza viruses A and B, Chlamydophila pneumoniae andMycoplasma pneumoniae bacteria that cause respiratory infections.Marketauthorisation of the Company's flagship product is an importantmilestone in the development of Genomtec S.A. and will have asignificant impact on the Issuer's operations and revenues. For thesereasons, in the opinion of the Management Board, this information meetsthe criteria of confidential information within the meaning of Art. 7sec. 1 MAR.

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