In April Alkor Bio Group has received a grant of Foundation for Assistance to Small Innovative Enterprises (FASIE/Bortnik Fund) in the competition “Commercialization III” for the project “Genetic diagnostic of cystic fibrosis based on microchip-technology”.

The Vega, affiliated company of Alkor Bio Group, took part in the competition. The Vega Company – is the union of five research laboratories and laboratory for molecular diagnostic, where the line of test systems made in microchip format and destined for diagnostics of severe hereditary disease cystic fibrosis has been developed. At the present time Laboratory of Molecular Diagnostic has developed and launched several test-systems for cystic fibrosis diagnostic, each of them has different mutations, included in diagnostic plate: Russian, European and Italian. All of them have a CE-mark, and it allows using the test-systems in diagnostic laboratories of European Union.

Under the terms of competition The Vega Company got 15 million rubles from Bortnik Fund and then bought new robotic system for printing of microarrays. Alkor Bio Group has allocated 15 million rubles more for the market research and purchase technological equipment for the optimization of the laboratory. New system bought on Bortnik allows launching more than 100 microarrays for the 5 hours. So the laboratory efficiency increased by 4 times. At the present time Alkor Bio Group’s Laboratory of Molecular Diagnostic is at the stage of scaling of the production process, and has orders for test systems made in microarray format.

Let us remind, the first test system is made in a microarray format and intended for molecular-genetic diagnostics of cystic fibrosis has been launched to the market in 2012 by Alkor Bio. Test-system “Cystic Fibrosis-BioChip” allows you to make a diagnosis in the first days of a child's life quickly and reliably. This innovation product can be used both for neonatal screening and cystic fibrosis screening for family planning. The uniqueness of kit “Cystic Fibrosis-BioChip” is that it allows you to analyze 25 mutations of the CFTR-gene most important for Russian population at the same time. “Cystic Fibrosis-BioChip” kit allows detecting cystic fibrosis in 95% of cases. It has a registration certificate of Federal Service for Surveillance in Healthcare and EU quality mark CE-mark.  This test-system has an interesting of medical genetics in EU. You should know that mutations of cystic fibrosis in European countries are different from mutations of this disease in Russia. So, Alkor Bio Group has developed microarray with extended list of mutations. At 2015 after all necessary verifications a new kit with 31 mutation of the CFTR-gene by reverse hybridization method has received a CE-mark. At the same time clinical tests of another modification of the microchip intended for diagnostics of cystic fibrosis in Italy completed successfully.

Interesting, some mutations of the CFTR-gene, rare for the European population, are quite common in several regions of Italy. Therefore the Alkor Bio Group’s laboratory of molecular-genetic diagnostics has developed an additional microarray with 20 more mutations especially for Italy.

Alkor Bio Group has developed software “Master-Microchip” for automatically interpretation of test results, getting on microarray. Use the program simplifies the work of laboratory doctors and geneticists, eliminates diagnostic errors due to subjective factors. The program “Master-Microchip” was translated on several languages: English, Italian, and Dutch.