Developers: | JVS Diagnostics |
Branches: | Pharmaceutics, medicine, health care |
2020: Registration in Rosportebnadzor
The company "Dzheyvis Diagnostiks", the resident Cluster of biomedical technologies of Skolkovo Foundation, received the registration certificate Roszdravnadzor on medical product "A set of reagents for quantitative determination cancer of antigen (onkomarker) of SA-62". Registration confirmed results of the conducted researches and also relevance of the offered onkomarker. Skolkovo Reported about it on April 28, 2020.
Clinical trials during registration of a medical product showed that the innovation marker of epitelialny carcinomas (MEC) will recognize types of different carcinomas which make about 90% of all cases of oncological diseases. This set shows sensitivity and specificity not less than 85% and is directed to quantitative identification of existence of a marker in serum of patients at different stages of cancer. The test will help the doctor to make the decision on presence of an oncological disease, to reveal progressing, to estimate efficiency of the current therapy.
For us registration of a medical product is actually equivalent to registration of a world priority for a marker of MEK/SA-62. During registration, at absence in the world of the available analogs, there was a need for carrying out the certified technical and clinical laboratory tests for the purpose of confirmation of capability of this marker to detect carcinomas of different localizations in adult population, irrespective of a floor and race. Now the company has the right to acquaint medical community with opportunities of use by doctors in the practice of the results received within testing, told Zhanneta Cherkasova, the CEO Dzheyvis Diagnostiks
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For April, 2020 a framework of accomplishment of the grant provided by Skolkovo Fund, the company continues to work on improvement of the available immunoanalysis.
It is pleasant to see when the project accurately designates the purposes and steadily reaches them. The Dzheyvis Diagnostiks command set the ambitious task – creation of the test for early diagnosis of oncological diseases. And, as we see, there are all premises in order that the task was successfully solved. Very much I hope that the product of the company will be estimated by professional community and is implemented in structure of practical health care, noted Anton Borovik, the senior project manager Klastera of biomedical technologies of Skolkovo Foundation
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