The new PrenaTest®express allows pregnant women at risk to receive the test results within one week
LifeCodexx cut the waiting time in half by using the latest technology for genetic analysis
Constance, Germany – With the new PrenaTest®express, LifeCodexx is able to reduce the waiting times for expectant mothers at risk for the test results to a maximum of one week. The PrenaTest®express is the innovative extension of the PrenaTest®, Europe’s first non-invasive molecular genetic blood test to determine fetal trisomies 13, 18 and 21 in the mother’s blood.
By using the latest technology for genetic analysis, LifeCodexx can determine a test result within one week and hence cut the stressful waiting time in half. If the deadline is not met, the pregnant woman may cancel the blood test at no cost. The PrenaTest®express is initially only available in Germany and, after a pilot phase, will be introduced in other European countries, too.
PrenaTest®express as well as PrenaTest® are exclusively for pregnant women who are in the finished ninth week of pregnancy or later and are at risk of fetal trisomies in the unborn child. Furthermore, in Germany, women opting for the PrenaTest® will need to take unbiased information and genetic counseling.
“With the new express option of PrenaTest®, in principle it is now possible that the doctor takes the blood for the test on a Monday and informs the patient about the test result on Friday in the same week,” commented Dr. Michael Lutz, CEO of LifeCodexx AG, the systematic further development of the PrenaTest®. “The introduction of the new PrenaTest®express demonstrates our innovation leadership in the dynamic field of non-invasive prenatal diagnosis.”
The analysis of both blood tests, PrenaTest® and PrenaTest®express, is exclusively performed in Germany and in strict adherence to the high quality standards persuant to the European In Vitro Diagnostic Directive. To date, about 6,000 women have decided for PrenaTest®. Less than 0.2 per cent of all samples could not be successfully analysed despite the requested repeat test. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis. PrenaTest® is available in numerous countries in Europe, Asia and the Middle East.
The non-invasive molecular genetic PrenaTest® is able to detect fetal trisomy 21 with a high degree of accuracy from maternal blood based on the use of next generation sequencing techniques. With its low false positive rate of 0.14% it further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. Thus, PrenaTest® is an innovative non-invasive prenatal diagnostic tool which complements common prenatal examinations, and, in contrast to invasive methods such as amniocenteses, does not carry the risk of procedure-related fetal losses. In accordance with the recommendations of the “ German Association of private physicians of prenatal medicine” (Bundesverband niedergelassener Pränatalmediziner, BVNP), the German Society of Human Genetics (gfh) or the International Society for Prenatal Diagnosis (ISPD), positive test results need to be further clarified diagnostically by means of an invasive examination. PrenaTest® is exclusively for pregnant women who are in the finished ninth week (W 9 + D 0) of pregnancy or later and have a risk of fetal trisomies in the unborn child. Furthermore, in Germany, women opting for the PrenaTest® will need to take unbiased information and genetic counseling as non-directive assistance in their decision making process by a qualified physician in accordance with the German Genetic Diagnostics Act and the guidelines of the Genetic Diagnostic Commission.
About LifeCodexx AG
LifeCodexx AG is a German life science company focusing on the development of clinically validated molecular diagnostic tests based on the use of next generation sequencing techniques. In 2011 the company has partnered with Sequenom, Inc. (USA) for the commercialization of prenatal laboratory testing services in Europe.