The Harmony® Test can be carried out on women who are in at least the 11th week of pregnancy (as of week 10+0).
Before carrying out a Harmony® Test your physician should give you an ultrasound scan to determine the gestational age and to check whether it is a singleton or multiple pregnancy. German law also requires that you receive comprehensive counseling prior to any genetic testing.
After completing the request form, your physician will draw two tubes of blood and send these to the laboratory. The analysis needs approximately 3 working days after receiving the samples. Your physician receives a report of the test result findings.
Requirements for the Harmony® Test
The Harmony® Test can be performed with all singleton or twin pregnancies, irrespective of the manner of conception (including in vitro fertilisation (IVF) and egg donation). Previous data indicates that the detection rate for twin pregnancies is not as high as for singleton pregnancies. Furthermore, in twin pregnancies a statement on sex chromosomal anomalies (X, Y) e.g. Turner or Klinefelter syndromes or the analysis of DiGeorge syndrome (Microdeletion 22q11.2) is not possible at the present time.
The table below provides an overview of which kinds of Harmony® Test can be carried out with which pregnancies.
| Harmony® Test |  | |  | |
| Harmony® with with X/Y analysis | | | | |
| DiGeorge syndrome | | | | |
| sex determination | | | | |
You will receive comprehensive genetic counseling from your physician on the results of the findings. In the event of a positive (i.e. abnormal) result, a definitive diagnosis must be determined through an amniocentesis or chorionic villus sampling, followed by subsequent chromosome analysis, before further decisions can be made regarding the pregnancy.
In accordance with the Genetic Diagnostics Act we are only allowed to inform your physician of the sex of the child when you reach week 14+0 of your pregnancy. If you wish to be informed of the fetal sex and have not yet reached the 14th week of your pregnancy, we will initially only send your physician partial findings (i.e. without the sex of your child). When week 14+0 of the pregnancy is reached, we will automatically send your physician the report including the sex of the fetus.
Our team of physicians and scientists will be happy to answer your questions on prenatal diagnostics, NIPT and the interpretation of the Harmony® Test.
Reasons why the test may fail
In a very small number of cases, the proportion of fetal DNA (cffDNA) in the blood may be too low for a result to be obtained. In such cases, Cenata will automatically repeat the test. If no clear result is obtained with the second test, we notify your physician that the findings could not be analysed. Cenata will not charge you for the unsuccessful test. You may wish to submit a new blood sample at a slightly later date since the content of fetal DNA in the mother’s blood increases with the length of the pregnancy.
Further reasons why the test may fail include the existence of an egg donation about which we were not informed, the death of one fetus in what was previously a twin pregnancy (“vanishing twin”), and previously undiagnosed (and normally benign) maternal chromosomal disorders.