Genomtec is an innovative medical technology company developing a unique mobile point of care genetic testing platform for the clinical diagnostics market. Its microfluidic lab-on-chip platform uses a patented non-contact heating and detection system and a proprietary LAMP based isothermal amplification method for infectious diseases and oncology. The company was founded in 2016 by a group of scientists with expertise in the area of molecular biology, microfluidics and photonics, is headquartered and has its laboratories in Wroclaw. Genomtec also has an office in the UK, where a part of their development and engineering team is located.
The company’s flagship project is Genomtec ID. Its development and commercialization will enable the diagnostic process to be conducted in point of care (POC), such as outpatient clinics, pharmacies, and hospital emergency wards, without the need for complicated and time-consuming laboratory handling provided by qualified personnel.
The unique features of Genomtec ID analyser is its compact size, low energy requirements, short turn-around time, and affordable consumables. All these features of the Genomtec ID put it in a leading position among the Molecular POC devices currently available on the global market.
The high level of innovation of the Genomtec ID solution, as well as the global sales potential, mean that the company plans to commercialize its projects in cooperation with an industry partner, which will be responsible for global sales of the device itself as well as tests.
The company does not plan to create its own sales network, and its intention is to focus as much as possible on developing the technology and solutions based on the technology. To maximize shareholder value, Genomtec’s business model is to sell a license or the entire technology to a global strategic partner.
Genomtec is constantly analyzing opportunities offered by the market and is striving to develop innovative products that maximize shareholder value and enable better patient care. One such area is in the field of Point of Care Oncology diagnostics and Companion Diagnostics.
Genomtec’s technology is protected by a range of issued patents and patent applications related to the Genomtec’s ID diagnostic platform itself, as well as the molecular biology.
Dear Shareholders and Investors,
We have been conducting intensive business activities within the M&A process and research focused on the development of Genomtec’s diagnostic technologies.
Our efforts are aimed at securing a partner or facilitating the sale of the technology we are developing. We are striving to maximize returns from this transaction for our shareholders. In the near future, we will continue to focus on the development of the technology and its commercialization, whether through licensing, the sale of a segregated part of the company, or the sale of Genomtec itself, depending on the direction of the M&A transaction.
We are continuing our meetings with potential partners, which also involve our participation in industry conferences that provide direct access to them. Additionally, we have conducted dozens of meetings and presentations of the Genomtec ID system, including to members of the management boards of potential partners. These discussions have led to signed non-disclosure agreements (NDAs). We currently have several NDAs in place, including with companies based in the U.S., some of which are listed on NASDAQ. These are major players in clinical diagnostics, biotechnology, and the pharmaceutical market. At present, we are in dialogue with R&D teams of potential partners, responding to their inquiries about the applicability of our technology and confirming its parameters.
Regarding the progress of clinical trials for the Genomtec ID platform, which are being conducted in France and Poland, further actions in this area will be closely aligned with the M&A process and its requirements. Should there be a need to accelerate these studies, this can be achieved by adapting the study protocol to meet the needs of the M&A process. For now, we are continuing patient recruitment according to the original study protocol. However, additional positive samples for atypical bacteria are needed, which are dependent on the occurrence and frequency of such infections, beyond our control. As a reminder, the European Commission has extended the deadline for mandatory registration of Group B in-vitro diagnostic medical devices under the IVDR framework from May 2025 to the end of 2029. Our current registration therefore remains valid for over five years.
In our oncology project, oncoSNAAT, our efforts have focused on further technology development. Recently, we have concentrated on detecting single nucleotide changes using the LAMP technique. Laboratory work in this area has been completed. The next step involves determining volumetric parameters for the sample, specifically liquid biopsy samples, such as those derived from venous blood. We have also begun work on methods for isolating/concentrating genetic material. Once these two aspects are finalized, we will be able to prepare a complete specification for the requirements of the microfluidic card.
We maintain a strong cash position, including over PLN 21.5 million in funding from PARP and proceeds from the equity issuance conducted this spring. The vast majority of the grant funds remain available for the next stages of the project, which is expected to conclude in the first half of 2027.
We thank our shareholders and investors for their capital support and contribution to Genomtec’s growth.
We are at your disposal and encourage you to contact us through the Investor Relations Team at: investors@genomtec.com.
Sincerely,
Miron Tokarski
CEO of Genomtec S.A.
Our history
On 16th February Genomtec debuted on the main floor of the Warsaw Stock Exchange.
Receipt of U.S. patent protection for the invention entitled “A method of detecting genetic material in a biological sample and a device for its implementation”.
Valuation of intellectual property portfolio by Dennemeyer Consulting. The value of Genomtec S.A.’s intellectual property portfolio was estimated at EUR 191.336 million
Agreement with transaction advisor Clairfield Partners LLC, based in New York.
Commencement of review of strategic options.
Obtaining EU CE-IVD certification for the Genomtec ID RP5-PLEX diagnostic panel.
Start of multi-center comparative studies of Genomtec ID system in France and Poland .
Charudutt Shah appointed by Supervisory Board to join Genomtec Management Board starting August 1st, 2021.
Participation in person in Arab Health Show in Dubai, UAE.
Launch of newly registered in EU, the world’s first genetic diagnostic test for the detection of SARS-CoV-2 directly from a saliva sample Genomtec® RT-LAMP Direct Kit.
Genomtec successfully co-organizes science and educational conference: “New technologies in the laboratory of the COVID-19 pandemic” with 430 participants and 708 registered diagnosticians to promote RT-LAMP technology.
Designating 17 March 2021 as the first day of listing Genomtec SA shares on the NewConnect stock exchange trading floor.
Introduction of Genomtec shares to the alternative trading system on the NewConnect market pursuant to a resolution of the Warsaw Stock Exchange. As previously announced by the Company, the debut will take place in the first quarter of this year and is planned for March.
Krzysztof Krawczyk, Head of the Polish branch of CVC Capital Partners – a global leader in the private equity industry – joins Genomtec’s Supervisory Board. He is joined by Krzysztof Dębowski, who has worked for many companies in the hi-tech sector, and currently serves as the managing partner at KnowledgeHub Starter – one of the leading venture capital funds in Poland.
Genomtec took third place in the 2020 “Maker in China” competition, directly supported by the China-CEEC SME Research Institute Government Organisation, in which over 300 companies from Central and Eastern Europe and China compete.
Genomtec took second place in the 4th edition of the international competition “China Shenzhen Innovation & Entrepreneurship” for its Genomtec ID product beating over 1,000 other projects. The company received a cash prize of almost PLN 400,000 (RMB 650,000).
Genomtec produces first 5 prototypes of Genomtec ID. The complete prototype allows conducting required tests for the reaction card, to optimize thermal parameters and to reduce the time of individual stages during result processing. The team is also working on developing the service and user interface software, as well as an algorithm for repeatable and reliable handling of the final version of the reaction card with improved fluid flow rate. The work also involves optimization of the optical system for fluorescence detection, which was parameterized for reliable detection of spectral emission specific for the dye used. Further work will include verification of optical filters to obtain the best fluorescence signal-to-noise ratio.
Genomtec introduces a new product to the market, a two gene test for SARS-CoV-2 detection using RT-LAMP technology, CE-IVD labelled for sales throughout the EU. In-house analyses confirmed the effectiveness of the test for detecting new SARS-CoV-2 variants, i.e. British, South African and Brazilian variants, with mutations that can affect the efficacy of the genetic tests that are currently available on the market.
The company successfully placed all of its 730,000 shares on offer as part of its IPO, and obtained over PLN 8 million, which the company will allocate to the Genomtec ID platform, its preparation for marketing and mass production. The offer went to institutional and individual investors. The interest of investors significantly exceeds the number of shares that the Company could allot to them.
Patent application filed with the Patent Office of the Republic of Poland for Chlamydia trachomatis diagnostic kit: “A set of primers, reagent composition and a method for detection of atypical bacteria”.
Commencement of the historical, first public offering through which Genomtec plans to raise PLN 8 million for the further development of its flagship project, Genomtec ID.
The company receives the Money.pl Economic Award for the best technology of 2020.
Genomtec is granted a patent by the American Patent Office for the invention entitled “Method of detecting genetic material in a biological sample and a device for its implementation”.
Appointment to the Board of Michał Wachowski as Chief Financial Officer. Before joining the team, Michał was the investment director of the VC fund. A graduate of the Warsaw School of Economics in the field of Finance and Banking.
Appointment to the Board of Jarek Oleszczuk, former president of the board of the Polish branch of the global pharmaceutical company Astra Zeneca, and previously the general director of Abbott Laboratories Polska. As Chief Business Officer (CBO), Jarek is responsible for the further development and implementation of the company’s business strategy.
Genomtec receives nearly PLN 7 million (EUR 1.6 million) of funding from the National Centre for Research and Development (NCBiR) for its flagship project – a mobile molecular diagnostics system – Genomtec ID, which will be able to detect, among others, COVID-19 within 15 minutes. Genomtec was among the eight finalists of the competition, which were awarded co-financing under the 2014-2020 Smart Growth Operational Program, measure 1.1 under sub-measure 1.1.1 “Fast Track”. The total value of the project “Development of mobile diagnostic equipment for COVID-19 detection” amounts to almost PLN 11 million net (approx. EUR 2.4 million), including PLN 7 million (EUR 1.6 million) in funding from the National Centre for Research and Development.
Obtaining a certificate of free sale (number 434/2020) from URPLiMB (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), for the diagnostic kit Genomtec® SARS-CoV-2 RT-LAMP/N CE-IVD Laboratory Kit. The certificate of free sale is issued for a product labelled with CE (it is the manufacturer’s declaration that the product that has been placed on the market meets the essential requirements, as well as legal regulations, quality and safety standards regarding this product) and reported to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in order to facilitate export. The document confirms that the product indicated therein, on the date of issuing the certificate, is or could have been marketed and used within the territory of the Republic of Poland.
Conclusion of a non-exclusive commercial cooperation agreement with Synektik S.A. concerning the distribution of SARS-CoV-2 tests developed by the Company in Poland. After the end of the initial period, i.e. 30 November, 2020, the terms of the contract negotiated by that time will enter into force, specifying the rules for further cooperation. The Agreement allows for the expansion of sales channels in Poland for the Company’s product lines, laboratory tests, and introduces active marketing of GNT (SNAAT®) technology in all channels used by Synektik S.A.
Obtaining patent protection on the territory of Poland for a patent application entitled “Method of detecting genetic material in a biological sample and a device for its implementation”.
Signing a conditional agreement with the UK-based CDMO company for the production of the Genomtec ID analyzer.
Obtaining the consent of the USPTO expert to receive a patent for the invention entitled “Method of detecting genetic material in a biological sample and a device for its implementation” in the USA, which is a significant step towards obtaining patent protection.
Filing two patent applications in the area of molecular biology under the name “Diagnostic Primers, Kits and Methods for Viral Detection” with the British Patent Office.
Filing an application with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for an invention entitled “Mycoplasma pneumoniae bacteria detection primer sets, Mycoplasma pneumoaniae infection detection method, Mycoplasma pneumoniae detection primer kit application” regarding small bacteria causing respiratory infections.
Patent application filed for a kit used in diagnosis of selected, most oncogenic human papillomavirus types: HPV 16 and HPV 18 (a virus responsible for cancer development, transmitted mainly during sexual intercourse or a direct contact with the skin of a virus carrier).
Genomtec signs a letter of intent with Astra Zeneca Pharma Poland concerning possibilities of commercial applications of the Company’s technology for diagnostics and personalized treatment of patients with non-small-cell lung carcinoma (NSCLC). It is one of the two main types of lung cancer, responsible for approx. 80% of cases.
Another patent application filed with the Patent Office of the Republic of Poland “Kit for contactless temperature control, method for generating electromagnetic radiation wavefronts and kit’s application for generating temperature field profiles” regarding the method of using electromagnetic waves for contactless heating, which has a broad range of industrial applications. Currently, the application is being processed at the EUIPO and local patent offices in China, Japan and USA.
Filing the first patent application in the field of molecular biology called “Primer kit for the detection of Borrelia burgdorferi, a method for the detection and diagnosis of Borrelia burgdorferi using a primer kit and kit for the detection of Borrelia burgdorferi” for bacteria that cause Lyme disease.
Filing a key patent application with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products under the name “Method of detecting genetic material in a biological sample and a device for its implementation”. Patent proceedings are pending at EUIPO and local patent offices in Canada, China, Japan and Brazil.
