Harmony prenatal test algorithm CE certified

The FORTE (Fetal-fraction Optimized Risk of Trisomy Evaluation Dynamic Linked Library) software is a cornerstone of the Harmony® Test. It enables the analysis of fetal cell-free DNA (cfDNA) from the maternal plasma, in order to determine the gender of the fetus, the risk for trisomy 21, 18 and 13 and for X and Y chromosomal aneuploidies.

Cenata confirms that the FORTE algorithm, which is being used as part of the Harmony® Test, is CE marked in accordance with the European IVD guidelines (directive 98/79/EC; annex II, list B).

The Harmony® Test is the only NIPT performed in Germany, whose algorithm is CE certified for all chromosomal abnormalities under investigation.

The blood collection tubes which are provided as part of the Harmony® Test are also CE certified by the manufacturer.