Since the beginning of May 2015 the non-invasive prenatal Harmony® test is being performed in Germany by Cenata GmbH. Cenata GmbH was founded jointly by Labor Enders, CeGaT GmbH and Prof. Dr. Hinrichsen. The Harmony® test reliably detects the most common chromosomal disorders in unborn children.
Maternal blood already contains not only genetic information of the mother but also genetic information of the child from an early phase of pregnancy. This so-called “cell-free fetal DNA” (cffDNA) can be investigated for the presence of chromosomal disorders in the unborn child (e.g. trisomy 21 – “Down syndrome”) using the Harmony® test. All that is needed is a blood sample from the mother.
Advantages of the Harmony® test
excellent detection rate of 99.5% for trisomy 21
very low false positive rate of 0.06% for trisomy 21
excellent clinical validation, e.g. the to date biggest clinical NIPT study with 18,955 patients