ScreenPlus: A comprehensive, multi-disorder newborn screening program.

"Declaration of Competing Interest MW has received consulting and speaker fees from Sanofi Genzyme, Takeda, and Orchard Therapeutics."

"Funding Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the 10.13039/100000002National Institutes of Health under Award Number R01HD073292. This work is support by grants from Abeona Therapeutics, Alexion Pharmaceuticals, the Michael, Marcia and Christa Parseghian Endowment for Excellence in Niemann Pick Type C Research doing business as the Ara Parseghian Medical Research Fund at Notre Dame, BioMarin Pharmaceutical, Cure Sanfilippo Foundation, Dana's Angels Research Trust, Firefly Fund, Genzyme Corporation, Noah's Hope - Hope4Bridget Foundation, Orchard Therapeutics, Passage Bio, Sio Gene Therapies, Takeda Pharmaceuticals, Travere Therapeutics, and Ultragenyx Pharmaceutical. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or above-named sponsors."

"Over a five-year period, ScreenPlus aims to enroll and screen over 100,000 infants born in eight high birth rate, ethnically diverse pilot hospitals in New York for a flexible panel of genetic disorders. Screen positive infants have confirmatory testing and follow up as needed, with capture of long term follow up data. This study also involves an evaluation of the ethical, legal, and social implications (ELSI) of screening newborns for complex disorders, which will be done via online surveys directed towards ScreenPlus parents who opt to participate, and qualitative interviews with families of infants who are identified through ScreenPlus and/or through routine NBS. The study has been approved by a single Institutional Review Board (sIRB) through the Biomedical Research Alliance of New York (BRANY; Protocol #19–10-212) and is registered on clinicaltrials.gov (NCT05368038)."