Materials

The Genomtec project, titled “Development of technology and an automatic system for mutation detection in clinical oncology based on lab-on-a-chip solutions and isothermal nucleic acid amplification techniques,” is among 198 applications positively evaluated by PARP in the SMART FENG.01.01-IP.02-001/23/2023 action within the European Funds for a Modern Economy program.

Genomtec has successfully completed an expansion of its Genomtec ID platform to the field of oncology diagnostics leading to its submission of a patent protection application for a novel oncologic diagnostic method that it developed. This method involves isothermal amplification of nucleic acids for the detection of genetic variants applicable for oncology diagnostics.

The Management Board of Genomtec S.A. has passed a resolution to determine how to distribute funds from a potential technology sale. The Company’s intention is for shareholders to benefit from a potential M&A transaction to the fullest extent possible. As part of its ongoing review of strategic options, Genomtec is working with a transaction advisor, Clairfield Partners LLC, based in New York.

Genomtec S.A. will debut on February 16 on the regulated market operated by the WSE. The Management Board of the Warsaw Stock Exchange issued resolutions on the ad-mission to stock exchange trading on the main market of series A, B, C, D, E, F, G, H, J, K shares of the Genomtec shelf and their introduction to trading.

Genomtec S.A. received from the German company Dennemeyer Consulting GmbH a valuation of the Company’s intellectual property portfolio. Accord-ing to the DIN/ISO 77100 standard adopted by Dennemeyer, covering 9 patents held by Genomtec and 26 patent applications, as well as the conversion of all patent applications into patents, as well as a 14-year protection period for the entire IP (intellectual property) portfolio, the fair value of Genomtec’s intellectual property was estimated at EUR 191.336 million.

Genomtec has signed an agreement with Clairfield Partners LLC, the New York based member firm of Clairfield International (“Clairfield”). The purpose of the agreement is to advise on the process of establishing strategic partnerships, selling licenses and/or selling all or part of Genomtec’s intellectual property and related technology.

Genomtec S.A. has decided to initiate a review of strategic options. In addition, it has signed an agreement with Dennemeyer & Associates, a global patent law firm to perform an assessment of the value of the Company’s Intellectual Property (IP) portfolio.

Genomtec has signed up a new Partner for the commercialization of its flagship Genomtec® ID genetic testing platform and the Respiratory Panel 5-Plex test. The Partner is appointed by Genomtec S.A. to help with identification and qualification of new local business prospects and opportunities for the Genomtec® ID platform in Taiwan.

Genomtec has appointed Richard Moore as the new Chief Technology Officer to drive its next generation of products and systems. Richard replaces Jason Reece who announced his intentions to retire.

Genomtec has secured an additional distributor for its Gentomec®ID portable testing platform and RP5-PLEX panel for detecting respiratory tract infections in Europe by entering into an agreement with ForLab SA. Forlab is the second distributor of the Company’s flagship platform after the Greek company Atropos.

Genomtec has obtained the CE-IVD mark for its flagship solution, the Genomtec®ID Respiratory Panel 5-Plex (RP5-PLEX) diagnostic panel for the detection of pathogens causing respiratory diseases. This is the only diagnostic panel of its kind that simultaneously tests for the presence of as many as 5 viruses and bacteria in the same test and which, thanks to CE-IVD certification, will be available for sale in 27 European Union countries as well as in Iceland, Norway and Liechtenstein.

Genomtec has signed an exclusive distribution agreement in Greece for its flagship Genomtec®ID genetic testing platform and the Respiratory Panel 5-plex test. Genomtec’s commercial partner Atropos Ltd., is a specialist distributor of molecular biology solutions with an established market position in Greece. Atropos will start the distribution following the regulatory approval of the Genomtec®ID platform and the test.

Genomtec has started the comparative testing phase of Genomtec®ID, a mobile platform for genetic diagnostics and the Respiratory Panel (RP) 5-plex assay. The results obtained in this clinical study will be the basis for the CE-IVD registration of Genomtec®ID in the European Union planned for the middle of this year.

Genomtec has received a patent from the European Patent Organization (EPO) for the Genomtec®ID technology and device invented by Genomtec SA. The invention under new patent protection includes Genomtec®ID, the Company’s key technology related to a proprietary non-contact heating and temperature sensing system developed for point-of-care testing (POCT) and other applications. This is the first patent granted by EPO and the seventh received by Genomtec. The company has more than twenty patent applications pending worldwide.

Genomtec has begun pilot production of analyzers for the first 15 Genomtec®ID devices. The analysers are being manufactured by the Genomtec team in the UK in close collaboration with the CDMO partner there. The start of production was made possible by the completion of the design and reliability testing of the analyzer components.

Genomtec has conducted an analysis of its rapid genetic tests that confirmed their effectiveness in detecting all known variants of the SARS-CoV-2 virus including the recently discovered Omicron variant.

Genomtec rapid genetic test sensitivity report.

Genomtec has filed a patent application entitled “Thermal interface arrangement” for a proprietary method of heat transfer and measurement with the UK Intellectual Property Office (UK IPO). The Issuer’s invention may have broad application not only in diagnostics, but also in biomedical solutions, electronics or mechanics.

Miron Tokarski, co-founder and CEO of Genomtec, found himself among the honourable laureates of the Forbes Magazine ranking: “Leaders of the Future”, organized by the Range Rover brand. Out of 140 nominated candidates the Chapter selected 10 Leaders, visionaries from various fields of life, who in one, five or ten years will be able to decide about the shape of the world.

Genomtec has received patent protection from the Polish Patent Office for a primer set for the detection of Human papillomavirus-16 (HPV16), a method for detecting HPV16 infection, and an application of the primer set for detecting HPV infection.

Genomtec released its Q3 2021 report. Q3 was a period of intensified work on Genomtec®ID – the company obtained 2 additional patents (in total it already holds 5). The patent issued by the Polish Patent Office for the non-contact heating and detection technology now has an expanded scope of being protected in any device or heating systems applicable outside the medical industry in addition to its current use in genetic applications such as Genomtec®ID.

Genomtec started today the analysis to accelerate the planned commercialization of the Genomtec®ID platform. The analysis will include the selection of solutions to support the company’s strategic development, primarily in terms of determining the optimal time to market with the Genomtec®ID solution, including its acceleration compared to the currently announced plan.

Genomtec today filed with the Polish Financial Supervision Authority (KNF) a prospectus prepared in connection with the planned transfer of the Company’s listing to the Warsaw Stock Exchange (WSE) main market. The Company’s main motivation for the transfer is to increase its visibility and gain access to a larger group of long-term investors, including foreign ones.

Genomtec has received notification from the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) that it has received patent protection for its invention, which is a contactless heating and detection technology that can be used not only in genetic research, as in the case of patent No. 235210 held by the Company, but also in any other type of devices or control systems designed outside the medical industry. This is the fifth patent received by Genomtec since the Company’s inception and the third issued by URPL.

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.