LifeCodexx performs close to 6,000 PrenaTest® analyses in its first year
Every second blood sample comes from Germany
Constance, Germany – In the first twelve months since its market launch in August 2012, nearly 6,000 women have decided for PrenaTest®. It is Europe’s first non-invasive molecular genetic blood test for the determination of fetal trisomies 13, 18 and 21 from maternal blood. The vast majority of the women (approx. 98%) could be relieved by an inconspicuous test result.
Almost half of the blood tests were ordered by German practices and clinics, about a quarter of the blood samples came from Switzerland and another quarter from other European countries. The increased maternal age (over 35 years), abnormalities on ultrasound, abnormal blood serum levels as well as psychological reasons were the main medical indications which caused the women to opt for PrenaTest® as a risk-free alternative to amniocentesis. The blood test was conducted mainly between pregnancy week 12 and 15. Two thirds of the women were older than 35 years at the time of testing. Several statutory as well as private health insurance funds have already covered the costs for the analysis on the basis of individual decisions.
“The demand for the PrenaTest® in the past twelve months is in line with our expectations,” said Dr. Michael Lutz, CEO of LifeCodexx AG. “In recent months, the demand for the blood test is steadily increasing since the physicians’ confidence in this new method is growing. For the physicians as well as for the patients it is important that the analysis is performed in Germany under high quality standards.”
Dr. med. Thomas von Ostrowski, gynecologist of the Fertility Center and Prenatal Medicine Dorsten, sees the PrenaTest® now firmly established in the prenatal diagnosis: “It is important to take the individual decision-making process of pregnant women into account. Thus, in the group of women with risk pregnancies detailed information about the available test methods is essential. Many women with risk pregnancies recognize the PrenaTest® as a sensible alternative and specificially ask for it. The test is a rational alternative to invasive diagnostics for all those women with an inconspicuous first trimester ultrasound, suspicious blood serum markers, and therefore the overall result requires re-examination. These are the pregnant women who have previously opted in Germany primarily for invasive diagnosis, although it is expected that most children are healthy.”
With its CE-marked software pursuant to the In-vitro Diagnostics Directive, PrenaTest® is the only marketable, non-invasive molecular genetic blood test in the EU to detect fetal trisomies 21, 18 and 13. The analysis is exclusively performed in Germany in LifeCodexx’ ISO 13485 certified laboratory in Constance, Germany.
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 below 0.1% 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.