Florida Institute for Pediatric Rare Diseases and Representative Adam Anderson ushering in a new era of preventative care with support from GeneDx’s comprehensive genomic testing and sequencing solutions

GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced Florida State University has selected GeneDx as one of its partners for the recently passed Sunshine Genetics Act, a groundbreaking initiative establishing the nation’s first state-backed genomic newborn screening (gNBS) program.

The Sunshine Genetics program, a five-year pilot program, will offer whole-genome sequencing for newborns at select academic medical centers and hospitals, providing families and clinicians the opportunity for early detection and diagnosis of rare diseases. Under the Sunshine Genetics Act, Florida becomes the first state to offer genomic newborn screening for hundreds of diseases, marking a historic expansion from research to the standard of care. The program’s goal is to sequence 100,000 newborns.

As the leading rare disease diagnosis company, GeneDx will provide support for this first-of-its-kind program through a combination of offerings, including end-to-end genomic testing, sequencing, expert interpretation, and clinical reporting. With the company’s unmatched scale and experience and having sequenced nearly one million exomes and genomes, GeneDx is uniquely positioned to partner with Florida to integrate genomic screening into routine pediatric care.

“We are honored to be a partner in Florida’s groundbreaking Sunshine Genetics program, the first state-backed effort to offer genomic newborn screening for hundreds of conditions helping ensure that every newborn in Florida has the best chance to live a long and healthy life from the start,” said Katherine Stueland, CEO of GeneDx. “With the launch of this program, Florida is setting a powerful example for how clinical practice can utilize genomic newborn screening to identify actionable insights early enough to stop disease progression before symptoms ever appear.”

Through its role as the sequencing and interpretation partner for the GUARDIAN study, GeneDx has already sequenced more than 17,000 newborns. The study demonstrated that genome sequencing at birth can identify a rare disease in 3.2 percent of newborns, representing over 100,000 babies each year who could benefit from early, targeted care for treatable but previously undetected genetic conditions.

“Having lost my own son to a rare disease when he was just 4 years old, I know firsthand how critical early diagnosis and rapid treatment can be. We are giving Florida’s families a life-changing opportunity to diagnose, treat and potentially stop disease progression before it ever starts. That is why we are so excited to be the first state to roll out newborn genomic screening,” said state Rep. Adam Anderson, who sponsored the Sunshine Genetics Act. “With the company’s integrated testing and interpretation solutions, GeneDx is the right partner to help us bring insights and information to parents and clinicians who deserve to have answers from day one. This is not only the right thing to do for families, it’s also a wise investment potentially saving our healthcare system billions of dollars annually. Florida can be the model for other states to ensure the healthy lives of all children, from day one.”

The Sunshine Genetics Act became effective July 1, 2025, creating a five-year pilot program to offer Florida families, free, voluntary whole-genome sequencing for newborns across the state to enable early detection of a comprehensive list of serious but treatable genetic conditions.

The program marks a critical development moving gNBS from research into practice. Spearheaded by Anderson and the Florida Institute for Pediatric Rare Diseases at Florida State University (FSU), the Sunshine Genetics Act marks the first state-wide genomic newborn screening public program. With funding from both the state and FSU, the program delivers genomic insights, otherwise unlikely to have been available, directly to families and clinicians to improve diagnostic outcomes and advance rare disease treatments and research to lead to better health outcomes for all.

With flexible capabilities, from full end-to-end testing to interpretation services as needed, GeneDx is well equipped to help the Sunshine Genetics program grow and evolve over time, adapting to the needs of clinicians, families, and the public health system.

“The Sunshine Genetics program represents a transformative step toward integrating genomics into pediatric care across Florida,” said Pradeep G. Bhide, director of the Florida Institute for Pediatric Rare Diseases (IPRD). “By combining the strengths of state leadership, academic medicine, and industry expertise, we are creating a model that will redefine early detection and intervention for rare diseases. This collaboration with GeneDx ensures that every newborn in Florida will have access to cutting-edge science that can change—and even save—lives.”

IPRD, located at the FSU College of Medicine, launched in February 2024 thanks to support from the Florida Legislature. The institute brings together scientists, clinicians and educators to tackle the challenges of pediatric rare diseases. In addition to the screening program, IPRD is launching a genetic counseling program as well as a pediatric health center and developing new diagnostic tools.

“This initiative exemplifies the promise of precision health,” said David H. Ledbetter, Senior Associate Director of the Florida Institute for Pediatric Rare Diseases. “Through statewide implementation of genomic newborn screening, we are building an infrastructure that not only improves outcomes for families today but also generates critical data to guide tomorrow’s discoveries. It is an extraordinary opportunity for Florida to lead the nation in translating genomics into public health practice.”

About GeneDx

GeneDx (Nasdaq: WGS) is the global leader in rare disease diagnosis, transforming the way medicine is practiced by making genomics the starting point for health, not the last resort. We bring together unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity™ – the largest rare disease dataset – built over 25 years from millions of genomic tests and deep clinical insights. This unparalleled foundation powers our ExomeDx™ and GenomeDx™ tests, giving clinicians the highest likelihood of delivering a timely, accurate diagnosis. GeneDx is shaping the future of healthcare by moving the standard of care from sick care to proactive healthcare. While our roots are in rare disease diagnosis, our commitment extends beyond – growing with the families we serve – as a trusted partner at every stage of life. For more information, visit genedx.com and connect with us on LinkedIn, Facebook, and Instagram.

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