Development of a Newborn Screening Assay for Angelman Syndrome and Prader-Willi Syndrome

"The assay developed in this study is determined to be FDA regulated as an exempt diagnostic device. In this study, the testing involved with this assay fulfills the following criteria:~* Is noninvasive~* Does not require an invasive sampling procedure that presents significant risk (the finger prick is minimal risk)~* Does not by design or intention introduce energy into a subject, and~* Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure, as participants will not receive results in this study."