2021.05.27

Genomtec expands patient group in the additional comparative study of its COVID-19 test directly from saliva

Genomtec S.A. will conduct additional comparative study of its test detecting SARS-CoV-2 directly from saliva sample utilizing the Direct-RT-LAMP technology against the reference RT-PCR method, executed via the agreement signed with the Cellgen Molecular Pathology Center (NZOZ Aurimed). The comparative study will be performed in the Cellgen’s laboratory. The acquired clinical data will enrich positive results obtained from currently running clinical validation research at the Central Clinical Hospital of the Ministry of Interior and Administration, which enabled market authorisation of the product in the European Union. The intentional effect of the Genomtec collaboration with Cellgen is obtaining analytical results from paired patients’ samples, which will provide deeper clinical diagnostic insights and enlarge the study group required by the foreign regulatory bodies to conduct additional international registration of the revolutionary Genomtec® RT-LAMP Direct Kit operating directly on saliva.

– Expanding the study number is extremely important from the perspective of distribution network development intended for innovative product adoption on international markets. It will help us to reach business partners and may accelerate product adoption on foreign markets. The greater number of participants enrolled in the comparative studies and the additional research centres partaking in the study may principally improve the quality and quantity of scientific publications on the product and the technology dissemination, said Miron Tokarski, Co-founder and the President of Genomtec.

The cooperative goal between Genomtec and Cellgen is execution of a comparative study informing SARS-CoV-2 virus detection effectiveness when conducted on the saliva samples employing Direct-RT-LAMP technology with a much-simplified process of saliva sample preparation for the amplification reaction compared to the commonly used RT-PCR technology requiring a laboratory RNA purification step.

– Since the beginning of the pandemic, as the diagnostic laboratory, we have been involved in the fight against SARS-CoV-2 virus, not only by performing the real-time PCR and antigen testing for our patients, but also by active participation in research projects. The collaboration with Genomtec provides patients with a new opportunitiy to eliminate nuisance associated biological material sampling. As a medical doctor with a diagnostic specialization, I am aware how important comparative studies are, particularly allowing product validation and thus informing new methods’ adoption into a routine medical diagnostic practice – emphasizes Łukasz Fuławka, the Founder of Cellgen and a Principal Investigator in the study.

In the last week Genomtec registered the world’s first diagnostic test Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit (RT-LAMP Direct Kit), which allows for identification of SARS-CoV-2 infection directly from the patient’s saliva. The innovative test will provide patients with a greater comfort, as they do not need to undergo the swabbing procedure, e.g. from the nasopharynx. The possibility of testing from saliva may also reduce the risk of virus’ contraction by the personnel collecting the sample, additionally sampling does not require specialized skills. Deployment of the Direct-RT-LAMP Kit permits receiving test’s results in just several minutes from the time the sample entered the laboratory. The registered test received market authorisation in the European Union. In Poland, will be performed it in the laboratory of the Dolnośląskie Centrum Medyczne DOLMED in Wroclaw, which is located at ul. Legnicka 40.

Genomtec tests are compatible with the devices already owned by laboratories utilizing Real-Time PCR technique, which may aid in releasing the diagnostic bottleneck without additional investment in the infrastructure and new personnel hires.