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Home NEWS Science News Biology

ACMG Launches Newborn Screening Coalition to Drive Evidence-Based Advances in National Newborn Screening

Bioengineer by Bioengineer
October 10, 2025
in Biology
Reading Time: 4 mins read
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ACMG Launches Newborn Screening Coalition to Drive Evidence-Based Advances in National Newborn Screening
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The American College of Medical Genetics and Genomics (ACMG) has taken a decisive step toward ensuring the continued advancement and integrity of newborn screening practices in the United States with the announcement of the formation of a Newborn Screening Coalition. This initiative emerges as a direct response to the dissolution of the federal Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), previously overseen by the Health Resources and Services Administration (HRSA), in April 2025. With this federal advisory body no longer operational, the landscape of newborn genetic screening risked fragmentation and delay, prompting ACMG’s proactive intervention.

Newborn screening is a fundamental public health service designed to identify infants with conditions that can benefit from early intervention before symptoms appear. The Recommended Uniform Screening Panel (RUSP) serves as the national standard list of conditions for state newborn screening programs. Historically, the ACHDNC was responsible for reviewing evidence and advising on adding conditions to the RUSP. The abrupt absence of this federal mechanism posed a critical challenge—how to maintain rigorous, evidence-based assessments of candidate disorders to safeguard newborn health and inform state programs consistently.

Recognizing this imperative, ACMG President Mira B. Irons, MD, FACMG spearheaded the establishment of a dedicated Taskforce tasked with crafting a viable framework for national oversight of newborn screening amidst this federal vacuum. This Taskforce, under the leadership of Dr. Cynthia Powell, MD, FACMG, convened a broad roundtable of over 120 experts from medical, laboratory, public health, and patient advocacy sectors. Their collaboration emphasized transparency, scientific rigor, and inclusivity, culminating in the recommendation to establish the Newborn Screening Coalition under ACMG governance.

This Coalition embodies a multidisciplinary approach, poised to fill the oversight void with authoritative, evidence-driven evaluations of genetic and congenital conditions proposed for inclusion on the RUSP. Unlike previous top-down federal advisories, the Coalition pledges to maintain an open process that welcomes public commentary and deliberates recommendations with full disclosure of scientific rationale—whether endorsing or opposing condition nominations. This commitment to transparency is key to fostering public trust and supporting policy decisions at the state and federal levels.

The technical operation of the Coalition involves a comprehensive review process where nominated conditions undergo systematic assessment of criteria such as disease prevalence, analytic validity of screening methods, clinical validity of test results, and the net benefit of early detection through screening. This evidence-based methodology aligns with established frameworks in genetic epidemiology and public health genomics, ensuring recommendations are grounded in robust data and clinical utility. By doing so, the Coalition aims to protect infants from harm due to delays in screening or the premature addition of insufficiently validated conditions.

Importantly, the Newborn Screening Coalition will serve as a collaborative nexus for medical geneticists, laboratory scientists, public health officials, and advocacy groups, emphasizing equitable access and preparation across diverse state programs. Such collaboration assures harmonization of screening standards nationwide amidst varied state capacities and infrastructures. The Coalition’s design anticipates a membership of 15 voting members, selected for their expertise and stakeholder representation, thus balancing scientific insight with patient-centered perspectives.

The Coalition’s launch, scheduled for the first quarter of 2026, comes with a strategic plan developed jointly by ACMG leadership and the ACMG Foundation for Genetic and Genomic Medicine. This plan addresses financial sustainability, operational logistics, and integration with existing ACMG educational and clinical programs. Ensuring long-term viability is crucial to support continuous innovation and adaptation as genomic technologies evolve and new disorders emerge for potential screening inclusion.

Dr. Irons emphasized ACMG’s longstanding dedication to advancing newborn screening since its earliest days, highlighting that this coalition reflects an ongoing commitment to science-driven policies that prioritize infant health and family well-being. Meanwhile, Dr. Powell remarked on the crucial role of timely, scientifically rigorous recommendations to support clinicians and families in decision-making processes. The Coalition aims to safeguard this process by avoiding gaps and ensuring an uninterrupted pipeline from research to clinical program implementation.

The broader impact of this initiative extends into the realm of public health policy and genomic medicine integration. Newborn screening represents one of the most successful applications of genetic testing, highlighting the translational potential of genomic discoveries. By providing a reliable national mechanism for assessing new screening targets, the Coalition supports innovation while maintaining high ethical standards, data transparency, and equitable health outcomes.

As genomic technologies become increasingly sophisticated—incorporating next-generation sequencing and multiplex assays—the criteria and processes for condition evaluation must similarly advance. The Newborn Screening Coalition intends to remain adaptable, revising evidence thresholds and implementation guidelines as scientific consensus grows and clinical practices evolve. This adaptability is essential to maximize health benefits while minimizing potential harms such as false positives or overdiagnosis.

In summary, the establishment of the ACMG Newborn Screening Coalition represents a critical evolution in the governance of newborn screening in the United States. It balances the urgency of early disease detection with systematic, transparent, and inclusive reviews, ensuring that all newborns receive the best possible start in life through evidence-based genetic screening. This model may serve as a blueprint for other nations and specialties where federal advisory bodies face dissolution or restructuring, illustrating how professional organizations can step in to uphold scientific standards and public health imperatives.

Subject of Research: People
Article Title: Information not provided
News Publication Date: October 10, 2025
Web References: http://www.acmg.net
References: Information not provided
Image Credits: Information not provided
Keywords: Developmental genetics

Tags: ACMG initiatives for newborn healthACMG leadership in genetic healthearly intervention in newborn healthensuring integrity in newborn screeningevidence-based newborn screening practicesfederal advisory committees and newborn screeninggenetic screening challenges in infantsnewborn screening coalitionnewborn screening policy advancementsprotecting newborn health standardspublic health newborn screening programsRUSP and newborn genetic disorders

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