MedTrace Logo

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

NCT05783791 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2023-09-06

No results posted yet for this study

Summary

The overall purpose of this project is to establish the capability of screening for Angelman syndrome (AS) and Prader-Willi syndrome (PWS) in public health newborn screening (NBS) programs, with an aim of developing and validating a screening test for AS and PWS.

Conditions

Interventions

DIAGNOSTIC_TEST

Newborn Screening Assay

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.

Sponsors & Collaborators

Principal Investigators

  • Mei W Baker, M.D., FACMG · University of Wisconsin, Madison

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2023-07-21
Completion
2023-07-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783791 on ClinicalTrials.gov