Improved PrenaTest® Provides Early Knowledge for High Risk Pregnancies

10 Jul 2013
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PrenaTest®, Europe's first non-invasive molecular genetic blood test to determine fetal trisomies 13, 18 and 21 in the mother's blood, can now be performed for high risk pregnancies after the ninth week (W 9 + D 0). Performing PrenaTest® at this early stage of pregnancy may be advisable, especially if mothers are at high risk due to a genetic disposition, e.g., the presence of Robertsonian translocation in one parent, or fetal trisomy was diagnosed during a previous pregnancy.

This became possible through the advancement of a method called QunatYfeX™ technology, which LifeCodexx uses to measure the amount of cell-free fetal DNA (cffDNA) in the mother's blood right at the beginning of the lab process. If the amount of this DNA is at least four per cent during the early weeks of pregnancy, LifeCodexx is able to reliably analyse the blood sample. This innovative QuantYfeX™ technology also allows LifeCodexx to notify the physician at the very beginning of the lab process, if the amount of detected cffDNA is too low. The physician can then promptly take a new blood sample which subsequently minimises the stressful waiting period for the anxious mother.

Further, LifeCodexx performed additional clinical validation of PrenaTest® together with its collaborative partner Sequenom Inc. on 340 samples from women with risk pregnancies. This confirmed the high quality of PrenaTest® with an overall detection rate of 100 per cent in this study. Based on the total collective of now 808 clinical samples, 99.8 per cent of all samples could be diagnosed correctly.

"Through the advancement of our QuantYfeX™ technology and its early integration into the PrenaTest® analysis, we are the first company worldwide, which is able to notify physicians and their respective patients immediately on accession of the sample, if the blood sample can be analysed," says Dr Michael Lutz, chairman of LifeCodexx AG. "Combined with additional automated lab processes we were also able to significantly lower the price for PrenaTest® in early June."

"The attending physician will decide during consultation of the patient, if the improved PrenaTest® is advisable before the ninth week of pregnancy," adds Dr Wera Hofmann, Medical Director at Life Codexx AG, in regard to the advancement. "According to the recommendations of experts, non-invasive molecular genetic tests such as PrenaTest® are especially advisable in connection with a first trimester ultrasound, which is performed between W 11 + D0 and W 13 + D6 of pregnancy."

With its CE-certified 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. To date, 4,000 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.

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Sonia Nicholas
Clinical Diagnostics Editor