Genomtec obtained the right to market in the EU Genomtec ID Respiratory Panel 5-Plex

After the statutory deadline for submitting a new medical device for in-vitro diagnostics at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Genomtec obtained the right to market Genomtec ID Respiratory Panel 5-Plex in the European Union, the company said.

The Genomtec ID RP5-PLEX diagnostic panel simultaneously detects the presence of influenza A and B viruses, RSV (Respiratory Syncytial Virus), SARS-CoV-2 and atypical bacteria Mycoplasma pneumoniae and Chlamydophila pneumoniae. The Genomtec ID analyzer, into which you insert the reaction card (panel) along with the patient sample to conduct a genetic test, is one of the smallest portable genetic laboratories in the world, it said.

"The launch of the company's flagship product is a significant milestone in the development of Genomtec S.A. and will have a significant impact on the issuer's operations and revenues, ”reads the release.

“We have just signed a distribution contract in Greece and are working on further commercial contracts. We would like to collect initial feedback from our partners on the device by the end of the year, which will be very valuable. We will also optimize the cost of manufacturing the device through cooperation with new, larger partners. We will consider what new solutions we should work on at the next stages of the company's development. I am very glad that we have achieved such an important legislative milestone as registration in the European Union and obtaining CE-IVD Certification. Now, an exciting new chapter is starting for us, ”said Genomtec Charudutt Shah's board member of business, quoted in the release.

Genomtec is an innovative technology company founded in 2016 in Wrocław. Works in the area of ​​molecular diagnostics. The company's flagship solution is the Genomtec ID mobile diagnostic system, operating on the basis of a microfluidic system and proprietary, patented SNAAT technology. The company is working on several solutions in the field of mobile molecular diagnostics. It also provides research and diagnostic services for enterprises and individual clients. Genomtec made its debut on the NewConnect market in March 2021.

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