During a year GeNext team had been conducting clinical trials of a new prostate cancer testing based on urine methodology.
Right now, we have successfully completed clinical trials which showed a good result. We consider that the development is implemented at the world level. Such approach to prostate cancer testing exists only in the United States. We have designed Russian analogue, which is at least equivalent,"- Andrey Toropovsky, CEO of GeNext, told.
Development was carried out on the basis of the Ulyanovsk NanoCenter, which is a part of RUSNANO network. The next stage of work is to obtain a registration certificate, which allows applying kits in Russian medical institutions. In the words of Andrey Toropovsky, in 2012 it has been proved that PCA3 molecules are only present only in urine from patients with prostate cancer. Laboratory testing enables detecting presence of this molecule in biological samples.
Biopsy is the only method of prostate cancer testing that is used in Russia.That new development allows to make biopsy redundant and enable patients to have the results of a urine test within just a few hours.
"We have received 200 samples of biological material from Kazan cancer center. The test accuracy was 70%. This result is comparable to what American scientists have shown. We are working hard to surpass this result. We have decided that the methodology should be improved for being used for screening purposes. We are going to strengthen other markers", - Andrey said.
TestGene's researches area is molecular genetic testing, the company has Eurasian patent. Since 2013 the company is based in the Ulyanovsk NanoCenter ULNANOTECH, in 2014 expended into a market with the novel solution for fetal gender and Rh factor testing using maternal blood. Now TestGene is developing a new test-system for early prenatal noninvasive testing of fetal abnormalities (Down, Edwards, Patau and other syndromes). The product is on stage of clinical trials. In accordance with internal clinical trials we expect the test accuracy will 90%. Now there are two ways to detect genetic abnormalities are Ultrasound and fetal blood sampling in Russian clinics.