Materials

Genomtec has received a notice of allowance from the Japan Patent Office (JPO) granting the Company patent protection for the Genomtec®ID device and the technology invented by Genomtec SA. The invention with the new patent protection covers the key technical solutions related to the proprietary contactless heating and temperature detection system developed for POCT platforms, including Genomtec® ID.

Company has filed a patent application for a proprietary primer set, diagnostic method and reaction mixture composition for genetic diagnosis of Salmonella enterica infections using the LAMP technique. The application was filed with the Patent Office of the Republic of Poland. The detection technology developed by Genomtec is faster and less expensive than those currently used on the market.

Genomtec S.A. has expressed its intention to seek a transfer of the Company’s listing from the alternative stock exchange of NewConnect to the main market of the Warsaw Stock Exchange (WSE). Accordingly, the Board of Directors has convened an Extraordinary General Meeting for September 13 this year, for Genomtec shareholders to pass a resolution authorizing the Board of Directors to carry out the necessary actions to transfer the listing of the Company’s shares. The listing on WSE is not planned to come with new issue of shares. The main objective of the Board is to access a larger group of long-term investors, including international ones.

Genomtec S.A. has published a report for the second quarter of 2021 containing financial results and a summary of the most important activities during this period, including a description of the progress of the Company’s flagship solution, which is a rapid mobile diagnostic platform – Genomtec ID. During the second quarter, the Company adapted the Genomtec ID prototype to pre-production and conducted EMC testing. The Company continued the development of the molecular diagnostic panels. Genomtec also received patent protection for a set of primers for duplicating the nucleotide sequence of Borrelia burgdorferi, the bacterium that causes Lyme disease, and filed another important patent application in the area of MRSA – infection of the body with methicillin-resistant Staphylococcus aureus. This is the third patent that the Company has obtained since commencing its operations.

Genomtec SA has been certified in accordance to ISO 13485 standard for its quality management system compliance via audits carried out by TÜV Rheinland – a prestigious, independent Certification Body. The certificate was awarded for the design and development of IVD devices for the detection of pre-determined pathogens and confirms Company’s top commitment towards quality development of medical devices. Obtained certification is necessary for the purpose of Genomtec ID mobile genetic diagnostic platform registration that is planned for mid-2022.

The Company has appointed a Scientific Advisory Board consisting of global experts in healthcare systems management and technology. The Board’s mission is to support Genomtec in the further development of the Company’s innovative technology, its business and products clinical development. Current appointees to the Scientific Advisory Board include: Eric Garnier – with 35 years of experience in the medical industry, and Prof. Krishnendu Chakrabarty – winner of numerous scientific awards, and holder of 18 patents in the US market, specializing in the area of microfluidic techniques. It is predicted for the future to extend appointees to the Scientific Advisory Board for specialists in the field of diagnostics and treatment of infectious diseases.

As part of our standard product surveillance and assurance strategy, and also due to growing concerns on ability of IVD tests to recognize newly appearing SARS-CoV-2 variants, Genomtec conducted bioinformatic (in-silico) as well as the wet lab analysis of its products, Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit (RT-LAMP Duo) and Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit (Direct).

The company announced in the draft resolution of the Extraordinary General Meeting of Shareholders convened on July 20 this year, with the intention to appoint Dr. Jarosław Oleszczuk to the Supervisory Board of Genomtec. At the time of publication of the draft resolution announcement by Genomtec Dr. Jarosław Oleszczuk resigned from his current position of a Member of the Management Board with an effect on June 23 this year. From August 1 this year the CBO role will be assigned to by Charudutt Shah – a newly appointed Member of the Genomtec’s Management Board.

Genomtec SA announced that Charudutt Shah is joining the board. The newly appointed member of the Genomtec board is a senior executive with many years of international experience, incl. in the area of business development, marketing and sales management and strategic planning in the clinical genetic diagnosis sector. He will start work at Genomtec on August 1, 2021.

The company 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.

Genomtec SA has registered and launched in the European Union market the Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit (RT-LAMP Direct Kit), which enables identification of SARS-CoV-2 infection from the patient’s saliva. The innovative test will provide patients with greater comfort due to lack of swabbing, e.g. from the nasopharynx. The possibility of testing using saliva will also reduce the risk of virus’ contraction by the personnel collecting the sample, additionally sampling does not require specialized skills.

The company has been granted a patent protection from the Patent Office of the Republic of Poland for a set of primers amplifying Borrelia burgdorferi’s nucleotide sequence , i.e. the bacteria causing Lyme disease. The patent developed by the Genomtec team covers the method of detecting Borrelia burgdorferi, the method of Lyme disease diagnosis, and a diagnostic kit for Lyme disease. It is the second patent granted by the Patent Office of the Republic of Poland and the third patent received by the Company. Currently, Genomtec has got pending twenty patent applications worldwide.

The company signed an agreement with the Lower Silesian Medical Center DOLMED S.A. – the leader of multidisciplinary healthcare provision in Wroclaw and Lower Silesia. The cooperation’s aim is to commence offering Genomtec’s products and services for patients in DCM DOLMED’s genetic diagnostic laboratory utilizing RT-LAMP technique for SARS-CoV-2 testing using Genomtec® SARS-CoV-2 EvaGreen® RT -LAMP CE-IVD Duo-Kit (RT-LAMP Duo Kit). Due to the close cooperation of both entities DOLMED will become the reference laboratory for products offered by Genomtec S.A.

Genomtec SA filed yet another significant patent application to The Polish Patent Office, Republic of Poland. The patent application concerns the proprietary set of primers, the diagnostic method and the reaction mixture composition for genetic diagnosis of MRSA (methicillin-resistant staphylococcus aureus) in the LAMP technique. The assay is part of the systemic infections diagnostic panel planned for Genomtec ID – a mobile genetic testing platform dedicated for doctor’s office, ambulance, airport or pharmacy.