LifeCodexx has announced that its PrenaTest, a non-invasive molecular genetic blood test to determine fetal trisomies 13, 18 and 21 in mother's blood, can now be performed even after the ninth week of pregnancy.
It may be advisable to perform the test at early stage of pregnancy especially if the mother is at high risk due to a genetic disposition such as the presence of Robertsonian translocation in one parent, or fetal trisomy was diagnosed during a previous pregnancy.
PrenaTest has now been advanced with LifeCodexx’s QuantYfeX technology.
With the help of this technology, the amount of cell-free fetal DNA (cffDNA) in the mother’s blood can be measured, right at the beginning of the lab process.
Even if the amount of this DNA is at least four per cent during the early weeks of pregnancy, LifeCodexx claims that the test can reliably analyse the blood sample.
Physicians can be notified right at the beginning of the lab process even when the amount of detected cffDNA is too low, following which doctors can then take a new blood sample which would subsequently reduce the stressful waiting period for the anxious mothers.
LifeCodexx in collaboration with Sequenom performed additional clinical study of PrenaTest on 340 samples from women with risk pregnancies, which confirmed the quality of the test with an overall detection rate of 100%.
LifeCodexx chairman Dr Michael Lutz said, "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."
Codexx medical director Dr Wera Hofmann said the attending physician will decide during consultation of the patient, if the improved PrenaTest is advisable before the ninth week of pregnancy.
"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," Hofmann added.