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Mandatory newborn screening in the United States: History, current status, and existential challenges
Shawn E McCandless1, Erica J Wright1
1Department of Pediatrics, Section of Genetics and Metabolism, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
Insights
Mandatory newborn screening (NBS) is a vital public health system. Recent challenges, including more screened conditions and false positives, risk public acceptance of this essential infant health program.
Area of Science:
- Public Health
- Genetics
- Pediatrics
Background:
- Mandatory newborn screening (NBS) has been a successful public health initiative since the 1960s.
- NBS is a comprehensive system involving testing, follow-up, outcome tracking, quality improvement, and education.
Purpose of the Study:
- To explore the history, current status, and challenges of NBS programs.
- To address new scrutiny and potential risks to public acceptance of mandatory NBS.
Main Methods:
- Review of historical development and current state of NBS.
- Analysis of factors driving NBS expansion, including new therapeutics and advocacy.
- Examination of challenges such as increased screening and false-positive rates.
Main Results:
- NBS expansion is now driven by therapeutics and advocacy, not just technology.
- Increased screening and false positives are creating scrutiny and potential risks to NBS acceptance.
- Federal oversight and harmonization efforts are increasing.
Conclusions:
- NBS systems face new challenges that require careful management to maintain public trust.
- Addressing false positives and ensuring effective communication are crucial for the future of NBS.
- The article provides suggestions for navigating these challenges and ensuring the continued success of NBS.
Abstract:
Beginning in the 1960s, mandatory newborn screening (NBS) of essentially all infants has been a major public health success story. NBS is not just a blood test, rather, it is a complex, integrated system that begins with timely testing, scrupulous follow up of patients, tracking of outcomes, quality improvement of all aspects of the process, and education of providers, staff, and parents. In the past, expansion of NBS programs has been driven by new testing technology, but now is increasingly driven by the development of novel therapeutics and political advocacy. Each state determines how the NBS system will be structured in that state, but there is increasing oversight and support for harmonization at a federal level. Several recent initiatives, together with the increased number of conditions screened and the concomitant increase in burdensome false-positive tests, are creating new scrutiny of NBS systems, and potentially pose an existential risk to the public acceptance of mandatory NBS. The history, current state and challenges for NBS are explored in this issue, with some suggestions as to how to address them.
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