LifeCodexx, a Germany-based developer of molecular diagnostic tests, has announced that its improved non-invasive molecular genetic blood test, called PrenaTest, can now detect chromosomal abnormalities, trisomies 13, 18 and 21, in women’s blood even after the ninth week of pregnancy.
PrenaTest is recommended to be perfomed during the early stage of pregnancy, especially for mothers who carry a high risk of genetic disposition, such as the presence of Robertsonian translocation in one parent or diagnosis of fetal trisomy during previous pregnancy.
The company claimed that the detection of these chromosomal abnormalties even after the ninth week of pregnancy has become possible with the PrenaTest, following its integration with a method, called QuantYfeX technology, through which the amount of cell-free fetal DNA (cffDNA) in the mother’s blood can be measured right at the start of the lab process.
Even when the amount of detected cffDNA is too low – at least 4% during the initial weeks of pregnancy – it can analyse the blood sample reliably.
Doctors could be informed right at the beginning of the lab process, following which they could then collect a new blood sample, which would subsequently lessen the period of waiting for high risk mothers.
As a non-invasive prenatal diagnostic tool, PrenaTest complements common prenatal examinations, and compared to invasive methods it does not offer the risk of procedure-related fetal losses.
The company, in collaboration with its partner Sequenom, conducted further clinical study of PrenaTest, for which 340 samples from women with risk pregnancies were collected and the study found that PrenaTest had an overall detection rate of 100%.
LifeCodexx also claimed that based on the total collective of about 808 clinical samples, the test could correctly diagnose 99.8% of all samples.
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."
LifeCodexx medical director Dr Wera Hofmann noted that, 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.
Dr Hofmann has, however, cautioned that the attending physician needs to decide during a consultation with the patient if the improved PrenaTest is advisable before the ninth week of pregnancy.
About 4,000 women have been diagnosed with PrenaTest to date and it is available in numerous countries in Europe, Asia and the Middle East.