Konstanz, June 7, 2017 :: LifeCodexx AG, a pioneer in non-invasive prenatal DNA testing in Europe has announced its partnership with LifeCell – India’s leading mother & baby preventive health care provider, to bring PrenaTesT® qNIPTTM testing for the first time to India.
The qNIPT™ technology that detects the presence of fetal trisomy 21 (Down Syndrome) from maternal blood, received CE marking (European Conformity) in December 2016 last year. This certification was obtained after a successful blinded clinical validation of around 1000 samples, demonstrating a 100% credibility of test results obtained from PrenaTest®. The novel qNIPT™ technology clearly demonstrates a significant cost-efficiency and rapid turnaround time compared to other NIPT techniques as it doesn’t rely on costly and lengthy sequencing methodology.
Down Syndrome (DS), also called Trisomy 21, is a condition where extra genetic material causes delays in a child development both mentally & physically and is one of the most common genetic birth disorders. Down Syndrome (DS) is associated with mild to moderate learning disabilities, growth milestone delays, typical facial features and low muscle tone in early infancy. Though Down syndrome can’t be prevented, it can be detected before a child is born.
India has the highest incidence of Down syndrome and it occurs in approximately 1 of 830 live births, as per Down Syndrome Federation of India. Through a series of screenings and tests, Down syndrome can be detected before the baby is born.
Routinely recommended prenatal screening tests are non-DNA based which unfortunately have lower detection rates (<95%) and higher false positives (5%). To confirm the diagnosis, further investigations are undertaken through invasive procedures causing a threat to the baby in the womb and added discomfort for the mother. Wider adoption of NIPT in global markets has substantially reduced the reporting of false positive diagnosis, which has reduced the need for any invasive tests by 60-70%.
With this exclusive technology partnership with LifeCodexx AG, LifeCell will be able to perform the licensed qNIPTTM PrenaTest® at LifeCell’s laboratories in Chennai (India) and will be the first in the
country to offer qNIPTTM technology that is more advanced than sequencing methodology being used by others.
Mr. Mayur Abhaya, CEO and MD of Lifecell said “We are excited to bring Prenatest® using qNIPTTM technology – the world’s most advanced NIPT technology to India that would lead to substantially lower parental anxiety, as they would be able to make better informed decisions with access to reliable and affordable test results, yet with no risk to the fetus”
Dr. Michael Lutz, CEO of LifeCodexx AG said “We are very pleased to have partnered with LifeCell since they have a long standing expertise in the field of preventive healthcare services for mother and child in the Indian market,”. He further added “We are certain that our qNIPT™ technology will find a ready market in India due to its high cost-efficiency and rapid turnaround time and also, considering that India has a birth rate of over 25 million children per year.”
““Our laboratory for Prenatest® is being set-up and the service will be available for our customers post the festive season,” Mr Mayur Abhaya confirmed. A formal announcement is expected to be made during Children’s Day this day for the commencement of the services. PrenaTest® will be serviced under LifeCell flagship brand BabyShield, the division specialized in mother & baby diagnostic services.
This partnership adds to LifeCodexx previous strategic partnerships in early 2016 when the company enhanced the PrenaTest® availability in Switzerland and Germany through several technology transfers. All technology transfers are aided by LifeCodexx’ PrenaBoxx® NIPT data analysis solution which is running locally with the CE-marked PrenaTest® software installed, capable of analyzing data from both NGS and qNIPT™ technology platforms.
About LifeCodexx AG
Headquartered in Konstanz (Germany), LifeCodexx AG has been developing innovative and clinically validated non-invasive molecular genetic tests based on the newest molecular analytical methods since 2010. With the PrenaTest®, Europe’s first non-invasive prenatal test (NIPT) for the determination of the most common chromosomal disorders in unborn children, launched in 2012, LifeCodexx AG has been changing prenatal diagnostics considerably. The test is currently performed within Germany and Switzerland in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices. With the development of a novel qPCR-based assay for the reliable prediction of preeclampsia early in the pregnancy, LifeCodexx AG will start to expand its product and service portfolio into the area of integrated pregnancy and prenatal care solutions.
Contact:
Elke Decker, MSc. MBA
Director Strategic Marketing and Corporate Communications
e.decker@lifecodexx.com
+49 (0) 7531-97 69 461
