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German Lab Receives ISO Accreditation for NIPT

NEW YORK (GenomeWeb) – The Center for Human Genetics and Laboratory Medicine today announced that its Prenatalis non-invasive prenatal test has received ISO 15189:2014 accreditation. 

The designation by the German Accreditation Body (DAkkS) makes the test the first in Germany detecting trisomies 21, 18, and 13 to meet the requirements of DAkkS, the center said. DAkkS evaluates the quality and accuracy of products, processes, services, and systems. Successful completion of the accreditation process demonstrates technical and medical competence of the lab, the center said. 

Prenatalis is based on Illumina' Verifi NIPT technology and was established and validated at the center's laboratory in Martinsried, Germany in cooperation with Illumina. Last week, the UK's Birmingham Women's NHS Foundation Trust said it was partnering with Illumina to develop an NIPT. 

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