LifeCodexx AG reports successful proof-of-principle of innovative PCR-based NIPT assay

Constance/Germany – LifeCodexx AG today reports the successful outcome of a proof-of-principle of its novel assay for non-invasive prenatal testing (NIPT assay) based on quantitative real-time PCR (qPCR). This NIPT assay, designed to determine fetal aneuploidies from maternal blood, will offer significant advantages, such as enhanced test performance at affordable prices, over other prenatal examination methods. The proof-of-principle study comprised 93 blood samples with eight positive trisomy 21 cases of which the assay unambiguously detected all positive samples.

 

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LifeCodexx expands its PrenaTest® spectrum and reports positive reimbursement decision in Germany

Constance, Germany – PrenaTest®, 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 PrenaTest® 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.

 

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New data confirms clinical benefit – PrenaTest® reduces the number of invasive prenatal diagnostic examinations by almost 70 %

Constance, Germany – A recent clincial study at the University Hospital in Basel (Switzerland) revealed that invasive examinations declined by almost 70 % within the first nine months after the introduction of the PrenaTest® in Switzerland. This result confirms the clinical value of the PrenaTest® as Europe’s first non-invasive molecular genetic prenatal diagnostic test for the determination of fetal trisomies 21, 18 and 13 from maternal blood. A total of 951 women were included in this independent retrospective study after first trimester screening and who had an elevated risk for fetal trisomies.

 

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PrenaTest® is now applicable for multiple pregnancies

Constance, Germany – As Europe’s first non-invasive molecular diagnostic blood test for the determination of fetal chromosomal aneuploidies from maternal blood, PrenaTest® has now successfully been validated 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 9th week of gestation. To date, several thousand PrenaTest® analysis have been been successfully performed in singleton pregnancies.

 

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The new PrenaTest®express allows pregnant women at risk to receive the test results within one week

Constance, Germany – With the new PrenaTest®express, LifeCodexx is able to reduce the waiting times for expectant mothers at risk for the test results to a maximum of one week. The PrenaTest®express is the innovative extension of the PrenaTest®, Europe’s first non-invasive molecular genetic blood test to determine fetal trisomies 13, 18 and 21 in the mother’s blood.

 

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LifeCodexx performs close to 6,000 PrenaTest® analyses in its first year

Constance, Germany – In the first twelve months since its market launch in August 2012, nearly 6,000 women have decided for PrenaTest®. It is Europe’s first non-invasive molecular genetic blood test for the determination of fetal trisomies 13, 18 and 21 from maternal blood. The vast majority of the women (approx. 98%) could be relieved by an inconspicuous test result.

 

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PrenaTest® now detects fetal trisomies 21, 18 and 13

Constance, Germany – PrenaTest®, Europe’s first non-invasive molecular genetic blood test to detect fetal trisomy 21 from maternal blood, now also tests for the existence of trisomy 13 and 18 with a high degree of accuracy.

 

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PrenaTest® is now available in over 30 countries in Europe, Middle East and Asia

Constance, Germany– Following the successful market launch of the PrenaTest® in Germany, Austria, Liechtenstein and Switzerland, Europe’s first non-invasive molecular genetic blood test for the detection of fetal trisomy 21 from maternal blood is now available in selected gynecologic practices and prenatal diagnostic clinics in Hungary, Bulgaria, Ukraine, Russia and Turkey.

 

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