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Signing a contract by a subsidiary for the production and development of documentation for a medical device - a study for SARS-CoV-2 diagnostics using the RT-LAMP method

Management Board of INNO-GENE S.A. [Inc] (Issuer) informs that it has received information from a subsidiary, i.e. Centrum Badań DNA sp. Z o.o. [Ltd.] (CBDNA) on signing a contract with MEDICOFARMA S.A. [Inc] .


Management Board of INNO-GENE S.A. [Inc] (Issuer) informs that it has received information from a subsidiary, i.e. Centrum Badań DNA sp. Z o.o. [Ltd.] (CBDNA) on signing a contract with MEDICOFARMA S.A. [Inc] regarding:

- preparation of documentation necessary to obtain the CE/IVD certificate and send the test to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [URPLWMiPB].

- launching the production and packaging of finished products, i.e. the SARS-CoV-2 diagnostic test using the RT-LAMP method according to the invention and the CBDNA patent application.

The signed agreement is exclusive, ie MEDICOFARMA will be the sole manufacturer of diagnostic kits in RT-LAMP technology. The estimated production potential of the plant is 2 million tests per week with the possibility of increasing through production orders for related companies. MEDICOFARMA has the appropriate potential and experience in the production of coronavirus diagnostic kits.

The parties allow the expansion of cooperation with further IVD diagnostic kits according to CBDNA technologies and inventions.

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