A Russian company has been conducting research and development and production of completed test-systems in the field of biotechnology and molecular genetics. The company developed reagent kits for foetal deoxyribonucleic acid based on the technology of real-time polymerase chain reaction, through which it is possible to define the gender and rhesus factor of fetus at 10 weeks of pregnancy. The company offers their products under commercial agency and distribution services agreements
The Russian company from Ulyanovsk specializes in noninvasive genetic diagnostics in obstetrics and oncology. The production laboratory of the company was certified in 2012, it is fitted with equipment for manufacturing of kits based on the technology of real-time polymerase chain reaction and quality monitoring procedure. The total area of laboratory manufacturing complex – 100 sq.m. Highly professional scientists with medical, biological education, participants of numerous international profile conferences, authors of a large number of scientific publications are on the staff of the company. The company presents in vitro diagnostics method of fetus sex detection starting from 10th week of pregnancy which allows to learn non-invasively Male or Female and is used as modern effective and reliable instrument in genetic diagnostics (proved by clinical trial). Identification is possible due to presence of free extracellular fetus deoxyribonucleic acid in mother’s blood which appears during 1st month of pregnancy and can be detected with a special laboratory kits. Also the company offers laboratory diagnostic test which allows to detect Sex-determining region Y gene of fetus in the mother’s blood using the presence of free extra cellular fetus deoxyribonucleic acid. Using the testing in obstetric-gynecologic practice allows to: - take timely measures to prevent sex-linked diseases; - avoid unnecessary and harmful immunoglobulin treatment for patients out of risk group; - reduce the risk of future health problems for mother and new born; - the best alternative to ultrasonography. Methods are non-invasive, 99% reliable. Tests can be easily performed in almost any molecular laboratory. The company is interested in finding partners from healthcare sphere to conclude commercial agency agreement, distribution services agreement for introduction and distribution of the company products in medical institution abroad. The partner is expected to purchase the product and then sell it on the foreign markets to final user.
Innovations and advantages
The innovative aspect: fetal deoxyribonucleic acid copies in blood of pregnant woman are detected. To achieve it ultra-short probes, unique primers and high processive hot-start polymerases are used. The accuracy of test is 99%. Professional taken sample at hospital, lab or patient home. The test is absolutely safe for fetus and for pregnant woman because only a small amount of maternal venous blood is using. The tests can be performed since 10 week of pregnancy. Time to implement test and to get results - 4 hours. The tests are easy-to-use and ready to apply in every polymerase chain reaction laboratory. The tests have passed clinical trials and complied Russian Certificate of Validation. High level of quality, certification of the enterprise on compliance to requirements of the International Organization for Standardization 9001:2008 and Conformité Européenne . Company headhunts gifted and promising specialists and has efficient personnel on all levels of production (4 staff scientists with Doctor of Philosophy). Continuous improvement and development of new products within the strategic directions of development of the enterprise. Advantageous geographical position of Russian SME.
06001005 Diagnostics, Diagnosis
Market application codes
05001002 In-vitro diagnostics
Intellectual property rights
Comments, number and date of patent
Russian Certificate of Validation (got in 2013) Eurasian patent (got in 2014) Conformité Européenne (confirmed in 2016)
Type of partner sought
Type of partner: SMEs of all types, universities, R&D institutions. Field of activity: healthcare companies, pregnant diagnostic centers, laboratory with polymerase chain reaction equipment, women’s health centers, genetic researching centers and Institutes. Partner’s role:- to purchase and resell the product to clinics or laboratories under distribution services agreement. Distribution agreement may be for a limited term, and be further restricted by territory and distribution channel; - to represent the kit to final user (to offer testing for pregnant women) under commercial agency agreement.