Early Check newborn screening study receives grant from Sanofi to test 1,500 additional newborns

The grant allows the study to screen newborns through at least 2025 and follow up with them through 2026

RESEARCH TRIANGLE PARK, N.C. - Nonprofit research institute RTI International today announced that Early Check, a groundbreaking research study that provides free voluntary health tests for newborns up to four weeks old in North Carolina,has received a three-year, $3 million grant from global health care company Sanofi. The grant will allow the study to screen 1,500 additional newborns and follow babies found to be at increased risk of type 1 diabetes through age two.

Early Check uses genome sequencing to screen newborns for hundreds of childhood-onset rare genetic conditions, many of which are not identified through the state's standard newborn screening. Parents can also choose to learn if their newborn is at increased risk to develop type 1 diabetes. Early symptoms of type 1 diabetes can be hard to recognize, yet screening is not routinely offered in clinical practice.

"We are grateful for Sanofi's support, which will increase Early Check's capacity to screen newborns and develop a screening approach that could be used more widely," said Holly Peay, Ph.D., a senior research scientist at RTI and the project's lead investigator. "We can now offer children found to be at increased genetic risk a follow-up test at nine months and two years to look for early signs of type 1 diabetes. The goal is to make the diagnosis early, connect children to specialists for appropriate management and optimize health outcomes."

The funding will also support research to make the genetic risk score the study uses to describe a newborn's future odds of developing type 1 diabetes more equitable across different ancestral groups.

Early Check began offering genome sequencing in September 2023. Since then, the study has returned results for more than 2,000newborns who were enrolled in the study by their parents when they were four weeks old or younger and identified more than 50 babies at increased risk for type 1 diabetes.

The newborns' parents have access to educational information and genetic counseling. Clinicians at the UNC School of Medicine also refer newborns to specialists across the state and contribute to the development of treatment plans as needed.

Early Check is led by experts at RTI and the University of North Carolina at Chapel Hill in partnership with the North Carolina State Laboratory of Public Health.

Learn more about Early Check and how to participate