Genomtec S.A.

Regulatory Filings • Jun 21, 2021

A contract signed with specialist clinical center based in Gliwice toexecute part of the comparative study (referenced to the Real-TimeRT-PCR method) validating the SARS-CoV-2 infection detection kit basedon the saliva Direct-RT-LAMP technology.The Management Boardof Genomtec S.A. ("Company", "Issuer") hereby informs that today, i.e.on 21th June 2021, it has signed an agreement with specialist clinicalcenter based in Gliwice to conduct part of the comparative study on thein-vitro genetic diagnostic kit for SARS-CoV-2 infection detectiondirectly from saliva samples using Direct-RT-LAMP technology, againstthe reference Real-Time RT-PCR method.Similarly to the informationprovided by the Issuer in reports 3/2021 and 11/2021, this is anaddition of a new clinical site with a purpose to perform amulti-cantered clinical effectiveness study of SARS-CoV-2 virusdetection directly from the saliva samples using Issuer's technology(RT-LAMP). Furthermore, the kit trials a simple and streamlined salivasample processing to the RNA-enriched supernatant being directly usedfor the amplification reaction set up, as opposed to the commonly usedRT-PCR technology requiring laboratory RNA purification.Theclinical data gathered for Genomtec®Direct-RT-LAMP test in this studywill me majorly used towards filling with the Regulator(s) requiring aminimal sample size to obtain sale authorisation for SARS-CoV-2diagnostic product in various markets. The date will be reported by theTeam from specialist clinical center, in addition to results' furtherdissemination in a form of a scientific publication or at scientificconferences.Achieved clinical performance data for theSARS-CoV-2 diagnostic kit will be incorporated in the larger clinicalevidence report encompassing already obtained positive results from theHospital of the Ministry of the Interior and Administration (CSK MSWiA)that permitted market access for the product in the European Union viaCE-IVD registration.The research project goal is mostly focusedon further diversification of the patients' population. The profile ofthe specialist clinical center, where majority of the patients'historical test results came negative, whereas the positive patientswere presented either with the asymptomatic disease or with very lowviral load infection, creates an opportunity to investigateeffectiveness of Issuer's Direct-RT-LAMP test in the diagnosis ofpatients creating potential risk of infection outbreak occurrence,confirming its adequate diagnostic parameters in identification of theasymptomatic cases (with low-viral load that means little amount ofvirus in patients' body).Moreover, an additional study'sgoal is to compare the cost and time needed for SARS-CoV-2 diagnosisbetween the Genomtec kit operating in the Direct-RT-LAMP technique andthe typical diagnostic procedure based on the Real-Time RT-PCR.Theobvious advantage developed by Genomtec saliva Direct-RT-LAMP method iselimination of the typical nucleic acid laboratory purification stage,thus reducing the time and cost of the entire procedure.The newtype of test provides more comfortable solution for patients, as it usesnon-invasive sampling - a simple saliva donation is enough to securebiological material being used for diagnosis. Furthermore, the use ofsaliva sampling reduces medical personnel's exposure to SARS-CoV-2infection.A comprehensive technology validation developed by theIssuer, in the event of further confirmatory positive results, maypropel sales of the diagnostic kit, causing increase in Issuer'seconomic development and generated revenue. For these reasons, in theopinion of the Management Board, this information meets the criteria ofconfidential information within the meaning of Art. 7 sec. 1 MAR.