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 10th 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.