Prenatalis® NIPT is a genetic test and subject to the German Gene Diagnostics Act (GenDG). The GenDG puts great emphasis on patient education, counseling and informed consent. Prenatalis® NIPT requires two genetic counseling sessions: prior to taking the test and when the result is announced.
The German Genetic Diagnostics Commission (GEKO) issued a guideline on the competence requirements in genetic counseling within the scope of each medical subspecialty.
A transitional regulation will be valid up to July 10, 2016, see also training courses of the State Medical Council, http://www.blaek.de. From July 11, 2016 qualified genetic counseling will require a further 72-hour curriculum of lectures (see also VII.3.4./ 8th announcement of the GEKO, in German).
The patient’s supervising physician is responsible for the patient education. He or she remains the patient´s principal contact person throughout the Prenatalis® procedure.