New diagnostic kits "IFA PAPP-A" and "Gonadotropin IFA — free beta-hCG" production "Alcor Bio", for prenatal screening for Down syndrome in 1 trimester of pregnancy, have been registered in the Russian Federation Roszdravnadzor.
It should be noted that today in Russia, as elsewhere in the civilized world, doctors try to translate the prenatal diagnosis with late pregnancy to early: in the first trimester, that is, to 13-14 weeks of pregnancy. Following current trends in the organization of prenatal biochemical screening, the Petersburg biotech company "Alcor Bio" developed "GonadotropinIFA-free beta-hCG" for the determination of the free beta subunit of hCG (human chorionic gonadotropin) and "IFA PAPP-A" for the quantitative determination of PAPP-A (a pregnancy-associated plasma protein A) in human serum by ELISA.
Application kits "GonadotropinIFA-free beta-hCG" and "IFA-PAPP-A" is relevant and promising, as significantly enhances the diagnosis of chromosomal abnormalities in the fetus in early pregnancy. After detection of fetuses with Down syndrome in 1 trimester of pregnancy during the combined screening with ultrasound marker — TVP and biochemical markers PAPP-A and free beta — hCG is 95%, while the detection of fetuses with Down’s syndrome as a result of prenatal screening for 2 terms does not exceed 75%.
Before the advent of the above sets for prenatal screening in one trimester, the company "Alcor Bio" produced a test system for examination of patients in the 2nd trimester of pregnancy and prenatal screening program for Down’s syndrome, "Isis." Thus, today the medical community offers a full range of products manufactured by "Alcor Bio" to identify the risk of having a child with Down syndrome, Edwards syndrome, overgrowth of neural tube defect, and developmental delay.
For the record: Down syndrome (trisomy of chromosome 21 pair) is incurable and is the most common genetic disease in humans, occurs in approximately 1 in 800 pregnancies. The transition to the I trimester screening can more accurately determine the risk for having a child with Down syndrome, reducing the number of pregnant allocated for invasive diagnostics. In addition, in the case of fetal Down’s syndrome and the decision to terminate a pregnancy, surgery in early pregnancy is much less traumatic than at a later date.
It should be said that in St. Petersburg over the past years, the work of medical genetic services came to a whole new level. Due to its success the number of pregnancies where the fetus has trisomy 21 by a pair of chromosomes and that for medical reasons were broken, exceeded the number of children born with Down syndrome. Until a few years ago in St. Petersburg, an annual average of 63-66 children born with Down syndrome. And, for example, in 2009, were diagnosed and 48 of these pregnancies are terminated. That is more than half. This figure corresponds to the highest international standards and is strong evidence for the effectiveness of medical genetic services. This qualitative leap has been made possible thanks to a number of measures. In particular, thanks to the massive prenatal screening: according to the order of the Health Committee of St. Petersburg, in all pregnant women free screening are two types: ultrasound and biochemical.
For the record:
St. Petersburg company "Alcor Bio» http://www.alkorbio.ru/ was established in 1992. Over the years the Russian market "Alcor Bio" has formed around the largest in the Northwest biotech cluster www.alkorbiogroup.ru. The company is currently "Alcor Bio" occupies a leading position among the domestic development and production of reagents for laboratory diagnostics: Diagnostic hormone (adrenal and thyroid, reproductive, etc.), diagnosis of cancer, infectious diseases (rubella, herpes, hepatitis B and C, HIV, etc.), allergy (test system and more than 50 kinds of allergens). Among the companies in the North-West region, working in the field of medical biotechnology, "Alcor Bio" is the most technologically advanced, as evidenced by the company in implementing the quality management system ISO 9001:2008 and ISO 13485:2003. Every year, "Alcor Bio" produces more than 200,000 sets of reagents for more than 60 titles, most of them have European quality mark — the CE mark. All diagnostic preparations produced "Alcor Bio", registered and certified Roszravnadzorom Russia. Currently, "Alcor Bio" is developing about forty innovative projects in the field of high biotechnology. The total investment in these projects is 20 million. Almost all of the scientific development of the underlying projects have a world novelty, and they filed patent applications. Most of the innovative projects "Alcor Bio" develops at the expense of own funds.