ESPERITE (ESP) upgrades TRANQUILITY, the most complete CE-IVD marked fetal DNA NIPT that accurately detects Down syndrome and other chromosomal abnormalities
(Thomson Reuters ONE) -
TRANQUILITY, the only CE-IVD certified genetic test for trisomies 21, 18 and 13
that provides, sexual aneuploidies, microdeletions and fetal sex detection, now
ready for mass market
Geneva, Switzerland - 30 April 2015
ESPERITE tops the trisomies detection market with TRANQUILITY: the CE-IVD marked
and risk-free fetal DNA test that accurately detects Down syndrome (>99,9%),
trisomies 18 and 13, sexual aneuploidies, microdeletions, and the sex of the
baby, reporting results within 5 days. TRANQUILITY's entire testing process for
trisomies (sample collection, preparation, sequencing, bioinformatics analysis
and report) is compliant with the European In Vitro Diagnostics Medical Devices
Directive 98/79/EC and has been certified by an independent body -UL
International. TRANQUILITY combines the technologies of Iona and InKaryo, the
recently acquired company now part of the ESPERITE group.
TRANQUILITY is suitable for all pregnancies and only requires a standard
maternal blood draw that can be performed any day of the week, from the 10(th)
week of pregnancy onwards. TRANQUILITY is risk-free for both fetus and expecting
mother. TRANQUILITY greatly restricts the need to undergo invasive testing
-amniocentesis- avoiding its risks altogether.
Genoma, the proteomics and genetic predictive medicine division of ESPERITE,
performs TRANQUILITY in its state-of-the-art lab in Geneva, the largest clinical
genetic center in Europe, with Next Generation Sequencing (NGS) technology.
Genoma's world-class experts use the whole genome shotgun sequencing method to
obtain the most comprehensive screening of the cell-free DNA circulating in the
mother's bloodstream which, during pregnancy, includes fetal DNA. Advanced
bioinformatics analyze the sequencing data with an enhanced calculation
algorithm ensuring top analytical performance, clear and accurate test results.
The Royal College of Obstetricians & Gynaecologists: "In time, this technology
is likely to become the primary screen for chromosomal abnormalities in
pregnancy. This will enhance the information available to pregnant women while
greatly reducing the loss of uncomplicated pregnancies as a result of
miscarriage caused by unnecessary invasive procedures." (Non-invasive Prenatal
Testing for Chromosomal Abnormality using Maternal Plasma DNA. Scientific Impact
Paper No. 15, March 2014).
TRANQUILITY's pilot phase registered several thousand sales over a short period
of time in Italy and Spain alone. Genoma's dual strategy for commercial
leadership in Europe aims to establish agreements with the public sector and
large private health institutions, in addition to distributing TRANQUILITY
through ESPERITE's local commercial structures in nearly 40 countries.
Over 14 million pregnancies are registered in Europe every year, including 5.2
million in Western and Southern Europe. The total prevalence rate of
chromosomal disorders at birth is estimated at 43.8 per 10.000 births. The
delayed childbearing pattern in Europe increases the risk of fetus abnormalities
significantly. The NIPT market is expected to reach USD 1.97 billion globally
by 2019 (Transparency Market Research, November 2014). Medical societies agree
that all pregnant women should be offered prenatal screening/diagnosis for fetal
abnormalities and that NIPT is a major advance in screening methodologies.
Given its higher accuracy, quality and safety, it is expected that TRANQUILITY
will replace traditional testing methods and become standard procedure as the
primary screen for chromosomal disorders for all pregnant women in the near
future.
Frederic Amar, CEO of ESPERITE group: "TRANQUILITY sets the golden standard for
prenatal testing. We are proud Genoma has reached this level of excellence,
raising the stakes in the market by offering doctors, women and families the
most reliable detection of chromosomal abnormalities at the early stages of
pregnancy."
About ESPERITE
ESPERITE group, listed at Euronext Amsterdam and Paris, is a leading
international company in regenerative and predictive medicine since 2000.
To learn more about the ESPERITE group, or to book an interview with CEO
Frederic Amar: +31 575 548 998 - ir(at)esperite.com or visit the websites at
www.esperite.com and www.genoma.com.
ESP PR Tranquility 30.4.2015 Eng:
http://hugin.info/143308/R/1917043/685734.pdf
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Source: Esperite N.V. via GlobeNewswire
[HUG#1917043]
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Datum: 30.04.2015 - 07:18 Uhr
Sprache: Deutsch
News-ID 389678
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