Genomtec S.A.

Regulatory Filings • May 25, 2021

A contract signed with Cellgen Molecular Pathology Centre, AurimedPrivate Healthcare Trust to execute part of the comparative study(referenced to the Real-Time RT-PCR method) validating the SARS-CoV-2infection detection kit based on the saliva Direct-RT-LAMP technology.TheManagement Board of Genomtec S.A. ("Company", "Issuer") hereby informsthat today, i.e. on 25th May 2021, it has signed an agreement with theCellgen Molecular Pathology Centre, Aurimed Private Healthcare Trust toconduct a comparative study on the in-vitro genetic diagnosis kit forSARS-CoV-2 infection detection directly on saliva samples usingDirect-RT-LAMP technology, against the reference Real-Time RT-PCR method.Similarlyto the information provided by the Issuer in the latest report 3/2021,this is an addition 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. Cellgen's studyTeam will create a clinical report, in addition to the results beingfurther disseminated in a form of a scientific publication or atscientific conferences; most importantly, it will provide the real-worlddate on the diagnostic performance of SARS-CoV-2 IVD device, improvingstatistical power of the already obtained results.Achievedclinical performance data for the SARS-CoV-2 diagnostic kit will beincorporated in the larger clinical evidence report whose development iscontinued despite the positive results being supplied by the firstclinical site, i.e. Hospital of the Ministry of the Interior andAdministration, permitting market access for the product the in theEuropean Union via CE-IVD registration. The greater number of patientsand research centres participating in the study are extremely importantfrom the perspective of the quality and quantity of scientificpublications discussing the product development and also the technologyitself.Moreover, an additional study's goal is to compare thecost and time needed for SARS-CoV-2 diagnosis between the Genomtec kitoperating in the Direct-RT-LAMP technique and the typical diagnosticprocedure based on the Real-Time RT-PCR. The obvious advantage developedby Genomtec saliva Direct-RT-LAMP method is elimination of the typicalnucleic acid laboratory purification stage, thus reducing the time andcost of the entire procedure.Firstly, the new type of testprovides more comfortable solution for patients, as it uses non-invasivesampling - a simple saliva donation is enough to secure biologicalmaterial being used for diagnosis. Secondly, the use of saliva samplingreduces medical personnel's exposure to SARS-CoV-2 infection.Acomprehensive technology validation developed by the Issuer, in theevent of further confirmatory positive results, may propel sales of suchan important for economic development diagnostic kit, generatingincreased revenue. For these reasons, in the opinion of the ManagementBoard, this information meets the criteria of confidential informationwithin the meaning of Art. 7 sec. 1 MAR.