Noninvasive Blood Test for Fetal Trisomies Now Certified for Multiple Pregnancies

A noninvasive molecular diagnostic test for the determination of fetal chromosomal aneuploidies from maternal blood has been validated for use in multiple pregnancies.

The LifeCodexx AG (Konstanz, Germany) PrenaTest has been validated recently for use in multiple pregnancies. It is the only blood test that can be used without any restriction following all methods of fertility treatment, such as IVF or egg donation, after the ninth week of gestation.

The PrenaTest is described as being Europe's first noninvasive, molecular genetic prenatal test. It determines the fetal trisomies 21, 18, and 13 from maternal blood reliably, rapidly, and safely. PrenaTest results were validated in a total of 870 samples from singleton and multiple pregnancies in several studies and provided a clear result in 99.8 % of all performed analyzes. With its low false positive rate of 0.1% it further clarified early diagnosis of fetal malformation and therefore reduced the number of unnecessary invasive examinations of non-affected pregnancies.

To perform the PrenaTest the physician draws 20 mL of blood, which is sent together with a signed declaration of consent to the LifeCodexx diagnostics laboratory, where the test is performed in strict compliance with the European in vitro Diagnostic Directive.

The analysis generally takes 10 working days or 6 working days with the new PrenaTestexpress (available in Germany since October 2013). The physician receives a letter with the result and informs the patient about the outcome of the analysis.

Standard trisomies 21, 18, and 13 can be detected by the PrenaTest with a high degree of certainty. In the context of clinical studies to evaluate the PrenaTest more than 99% of all blood samples were correctly classified. In only one sample was an existing trisomy 21 not detected (false negative), and in one other sample there was a trisomy 18 indicated although in reality this was not present in the unborn child (false positive).

"We are happy to report that we correctly classified all trisomy cases with the PrenaTest in a validation study which included 62 twin and triplet pregnancies,” said Dr. Michael Lutz, CEO of LifeCodexx AG. "With the successful validation of the PrenaTest for multiple pregnancies, we have set high standards again in this innovative field of non-invasive prenatal diagnosis."

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