LifeCodexx expands its PraenaTest® spectrum and reports positive reimbursement decision in Germany
Additional PraenaTest® options for the exclusive determination of fetal trisomy 21 and gonosomal aneuploidy now available
Constance, Germany – PraenaTest®, Europe‘s first non-invasive molecular genetic prenatal diagnostic test (NIPT) to determine fetal chromosome disorders from maternal blood, now comprises two additional test options. One new option allows physicians to add the determination of fetal gonosomal aneuploidy for singleton pregnancies, such as Turner, Triple X, Klinefelter and XYY syndrome, to the standard analysis of fetal trisomies 21, 18 and 13. The second new option exclusively determines trisomy 21 in the unborn child. Therefore, depending on the medical issue, physicians and their patients can now select from a total range of three PraenaTest® options for singleton and multiple pregnancies with an average waiting time for the test results of eight working days or even four working days, if express service is selected.
“The new PraenaTest® portfolio strengthens the physicians’ competence to decide which chromosomal disorders are to be determined. Now they can adapt the genetic examination according to the patient’s individual needs,“ says Dr. Michael Lutz, CEO of LifeCodexx AG.
Following LifeCodexx´ application to the Federal Joint Committee of Germany (G-BA) in 2013, the company recently received a positive decision concerning statutory health insurance coverage for the PraenaTest® analysis costs through a novel reimbursement scheme (“Erprobungsregelung”) in Germany. Starting 2015, this scheme will allow patients to be refunded by their statutory health insurances for a trial period during which a reimbursement-driven clinical validation will be performed. PraenaTest® was selected by the committee for this study as it strictly complies with the high quality standards in accordance with the European In Vitro Diagnostic Directive and due to its use of the CE-marked data analysis software as a medical device.
A new study regarding the validation of the PraenaTest® in multiple pregnancies and the impact of vanishing twins in NIPT has recently been accepted by the Journal of Clinical Medicine for publication. It is the second peer-viewed publication regarding the clinical validation of the PraenaTest® in singleton and multiple pregnancies. To date, more than 11,000 women have opted for PraenaTest®. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis on individual basis.
PraenaTest®, Europe’s first non-invasive, molecular genetic prenatal test, determines the fetal trisomies 21, 18 and 13 as well as gonosomal aneuploidy from maternal blood reliably, rapidly and safely. It further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. Thus, PraenaTest® is an innovative non-invasive prenatal diagnostic tool which complements common prenatal examinations, and, in contrast to invasive methods such as amniocentesis, does not carry the risk of procedure-related fetal losses. PraenaTest® is for pregnant women who are in the 9th week of gestation (W 9 + D 0) and who have an elevated risk of chromosomal aneuploidies in the unborn child. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis in many cases. The PraenaTest® analysis is performed in Germany (Konstanz) in strict compliance with the high quality standards in accordance with the European In Vitro Diagnostic Directive.