The Lifechanging Power of Newborn Screening: A Critical First Step in Rare Disease Care

Each year, nearly 4 million babies are born in the United States—and thanks to newborn screening, thousands of them are given a chance at a healthier future. This simple yet powerful public health program identifies over 12,000 infants annually who are at risk for serious, often rare, conditions¹.

Yet despite its success, the U.S. newborn screening system faces significant structural challenges—particularly when it comes to adding new conditions to the Recommended Uniform Screening Panel (RUSP). While the RUSP provides a federally recommended list of conditions, each state decides independently whether and when to adopt new additions.

This decentralized process frequently results in long delays: it historically has taken an average of 5 to 6 years for states to begin screening for a condition after it is added to the RUSP¹. As a result, babies born in states that lag behind may miss the opportunity for early diagnosis—simply because of where they live. Furthermore, the federal advisory committee responsible for adding new conditions to the RUSP was recently terminated, so the future of the RUSP is unclear.

Today, only 52% of babies in the U.S. are born in states that have adopted legislation to align with the full RUSP². This patchwork approach creates inequities in rare disease care where we know early detection can be critical. These diseases can progress rapidly and irreversibly if left undetected, yet because they are so uncommon, it can be difficult to build the case for universal screening. This tension between rarity and impact underscores a central challenge in rare disease policy.

Sanofi, alongside advocacy organizations, supports efforts to streamline this process and ensure that all babies—regardless of geography—have equal access to timely, life-changing screening.

As science advances, it’s essential that our newborn screening programs evolve too. Sanofi continues to lead in this evolution— by supporting advocacy efforts at the state and federal level in advancing NBS policies, providing educational support to state laboratories and primary care providers, and furthering genomic newborn screening through research grants and multi-stakeholder consortium activities. From supporting research grants to championing newborn screening legislation, Sanofi is helping shape a future where every baby is given a chance at a healthier future.