September 21, 2017

Prenatalis® NIPT remains unaffected by the patent dispute

Martinsried. The Prenatalis® NIPT is unaffected by the patent case between the companies Illumina® and Sequenom. The provision, evaluation and reporting of the Prenatalis® occurs entirely in Germany.

By means of a technology transfer agreement with Illumina®, MVZ Martinsried secured the rights to use the patent pool for conducting the analysis of cell-free DNA at the time of Prenatalis® market entry in 2014. MVZ Martinsried is the only laboratory in Germany to be accredited by DAkkS for the provision of an NIPT. One of the most important quality features of Prenatalis® is its very low failure rate. The non-invasive prenatal test provides a reliable result even with a very low fetal fraction. Therefore, it is particularly suitable for women in the early stages of pregnancy or obese pregnant women.           

February 1, 2016

Analytical quality through great sequence depth

Martinsried. The Center for Human Genetics and Laboratory Diagnostics is the only laboratory in Germany accredited to DIN EN ISO 15189:2014 to carry out the non-invasive prenatal test Prenatalis®.

Prerequisite for obtaining accreditation through Germany’s National Accreditation body (Deutsche Akkreditierungsstelle GmbH, DAkkS) was the careful execution and high reliability of the NIPT procedure. The analytical quality of Prenatalis® is reflected in the sequence depth of up to 21 million reads per sample. Even from samples with a low fetal fraction (2.7%) of cell-free fetal DNA (cffDNA), a valid result can be obtained due to the great sequence depth. The medical laboratory in Martinsried determines the amount of cffDNA in both male and female fetuses. The determination of the fetal fraction from maternal blood was essential to obtain accreditation.

October 30, 2015

Medical quality for expectant mothers - Prenatalis® NIPT relaunches its website

Martinsried. The Center for Human Genetics and Laboratory Diagnostics in Martinsried has relaunched its website for the non-invasive prenatal test Prenatalis® that detects fetal trisomies 21, 18, and 13 and gonosomal defects. Prenatalis® NIPT has been part of the diagnostics portfolio of in Martinsried since mid-2014.

The modern design of the website is transparent, clear and informative and adapts to the screen size so that users can access the contents of the Prenatalis® website on all devices. The Center for Human Genetics and Laboratory Diagnostics as a medical-led laboratory with interdisciplinary diagnostics, places great importance on the new web presence, which addresses the needs and wishes of both healthcare professionals and expectant mothers by providing detailed information for each group.

Prospective parents can find information on the test procedure, the meaning of the test result, and the benefits of an accredited genetic test such as Prenatalis®. They can use this information as a basis for discussion with the treating physician.

The website offers healthcare professionals information on the technology and method of NIPT. Additionally, they can find information on important congresses and symposia as well as up-to-date news on billing, liability and safety of the test. All necessary documentation for the implementation of the test, as well as information brochures are available in the "Downloads" section. The greatest benefit to website visitors is the fast access to relevant information and the user-friendly design.

July 22, 2015

Quality award for German Prenatalis ® NIPT - accreditation according to DIN EN ISO 15189: 2014

Prenatalis® is the first NIPT in Germany to fulfill the high quality requirements of the German national accreditation body, DAkkS

Martinsried. Prenatalis® has received the DIN EN ISO 15189: 2014 accreditation from the German national accreditation body DAkkS. With this accreditation, it becomes the first and only non-invasive prenatal test (NIPT) available in Germany to detect fetal chromosomal abnormalities (trisomy 21, 18, 13 and gonosomal defects) that meets the stringent quality requirements of DAkkS.

Prenatalis® NIPT has been part of the diagnostics portfolio of the Center for Human Genetics and Laboratory Diagnostics in Martinsried since mid-2014. It is based on the Illumina Verifi® NIPT technology and was established and validated at the center's laboratory in Martinsried, Germany.

Non-invasive prenatal genetic testing detects, with a high degree of certainty, the incorrect distribution of the chromosomes 21, 18 and 13 as well as the sex chromosomes by the analysis of cell-free fetal DNA circulating in maternal blood. The test is carried out under medical supervision at the Center for Human Genetics and Laboratory Diagnostics. The center attaches particular importance to comprehensive patient education, as well as competent genetic counseling of pregnant women before and after carrying out the test.

Medical laboratories can be awarded accreditation according to DIN EN ISO 15189, after successfully completing an accreditation procedure that includes on-site assessments by specialist experts appointed by DAkkS. These assessments ensure the highest possible level of quality and competence.

By receiving accreditation, the Center for Human Genetics and Laboratory Diagnostics in Martinsried has set a new quality standard for non-invasive prenatal testing. Although there are several companies offering NIPTs in the German market, only Prenatalis® has the highest quality accreditation in combination with implementation in a medical laboratory and the high data protection requirements only guaranteed by complete implementation in Germany.

DAkkS certificate