Subscribe to news

HSCI Opens NIPT Lab in Moscow

Moscow – 7 June, 2017. PJSC “HSCI” – The Human Stem Cells Institute (“HSCI”, MOEX: ISKJ), one of Russia’s leading biotech companies, today announced that its subsidiary, GENETICO LLC, has launched Russia’s first specialized laboratory to conduct a full cycle of non-invasive prenatal testing (NIPT) based on Ariosa Diagnostics' Harmony™ technology.

HSCI’s Genetico® laboratory has made technology transfer and from now has become the first in Russia and the CIS equipped by Roche (who acquired Ariosa Diagnostics Inc. in 2015) to produce the Harmony™ Prenatal Test locally.

The transfer of one of the world-leading testing technologies to Russia was carried out in cooperation with Roсhe Diagnostics and with the support of the Russian State Industrial Development Fund (IDF), RVC BioFund and the Agency for Strategic Initiatives (ASI).

From 2014 up to now NIPT was offered by HSCI in Russia as a send-out test. Opening the NIPT lab in Moscow significantly shortens the time of analysis and reduces costs to make the test financially accessible to a larger number of expectant mothers in Russia and the neighboring countries.

A service of non-invasive prenatal testing followed by a genetic consultation on the results is provided by HSCI’s Genetico® center & lab under Prenetix® brand name.

According to Dmitry Boguslavsky, the CEO of GENETICO LLC, HSCI’s subsidiary: «The performance of Harmony™ NIPT is confirmed by rigorous and extensive published international studies. According to them, it can reduce the number of invasive procedures caused by false-positive results by 88%, and diminish the number of abortions caused by invasive prenatal testing by 94%. Therefore, we see our mission as to make Prenetix®/ Harmony™ Prenatal Test maximum accessible to pregnant women, while introducing it widely into medical practice in Russia».

Prenetix® / Harmony™ Prenatal Test is a non-invasive prenatal testing for fetal chromosome aberrations using maternal venous blood. It can be performed as early as 10 weeks in pregnancy to assess the risk of having a child with Down syndrome (Trisomy 21, disease prevalence 1 : 700) and other most common chromosomal disorders (Trisomy 18 - Edwards syndrome, disease prevalence 1 : 6 000; Trisomy 13 - Patau syndrome, disease prevalence 1 : 7 000; 47,XXY or XXY - Klinefelter syndrome, disease prevalence 1 : 700; 45,X or 45,X0 - Turner syndrome, disease prevalence 1 : 1 500; other sex chromosome aneuploidies, such as XXX - X chromosome gain in females, and XYY -Y chromosome gain in males, disease prevalence: 1 in 1 000).

Elaborated in the USA, Ariosa Diagnostics' Harmony™ Prenatal Test delivers a high level of accuracy on the back of a proprietary cell-free DNA technology (AcfS) including precise measurement of fetal fraction found in maternal blood and individualized results scoring.

By delivering clear information, Harmony™ may minimize anxiety and follow-up invasive procedures: it has detection rate greater than 99% for Trisomy 21 (conventional screening tests can miss 15% or more of Trisomy 21 cases) and a false positive result of less than 0.1% (conventional first trimester screening returns false positive results up to 5% of the time that means out of 20 women who have further invasive test (amniocentesis) the pathology is really diagnosed in only 1, and others turn to have been exposed to the risks for themselves and their fetuses unreasonably).

The technology has been validated by a robust clinical data set and supported by blinded clinical studies in more than 23,000 women of all ages and risk categories, with all the results having been published.

By now, more than 1,000,000 pregnancies have been tested worldwide since Harmony™ initial introduction in 2012.

07 June 2017