New Laboratory Screening Test for Fragile X Syndrome Shortly after Birth Now Ready for Pivotal North Carolina Early Check Clinical Study

RTI International, a leading non- profit research institute, and Asuragen, a molecular diagnostics product company, announced today their scientific collaboration using a new, high performance screening technology to test for fragile X syndrome in newborns. The technology will be utilized via high throughput process in North Carolinas Early Check study, the largest clinical study of its kind.

Early Check is a free screening study designed to identify children with rare health conditions before symptoms appear and study the benefits of early interventions. After receiving the mothers consent, Early Check reuses the same blood sample taken for regular newborn screening to test for additional rare conditions, including fragile X syndrome, the leading inherited cause of intellectual disability. Until now, screening for fragile X syndrome has been limited by the availability of a high throughput, accurate method that works for both boys and girls

By using this testing method in Early Check, we will be able to better understand the prevalence of the fragile X gene disorder, said Don Bailey, PhD, Distinguished Fellow at RTI International and principal investigator for Early Check. Our goal is to enable studies of the earliest childhood development issues and potential interventions by identifying fragile X syndrome in infants shortly after birth.

With Asuragens technology, newborn testing for the fragile X gene disorder can potentially be done with large numbers of children. We are proud to partner with RTI International on Early Check, said Gary Latham, senior vice president Research & Development at Asuragen. We hope that the use of this technology in such a large-scale study will help to drive how testing of newborns for many genetic disorders can be realized in the future.

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About RTI International

RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approachone that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.

About Asuragen

Asuragen is a molecular diagnostic product company changing the way patients are treated in genetics and oncology. Asuragens diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. Asuragen is a product foundry rapidly and efficiently addressing current and emerging clinical needs, including cancer diagnosis and monitoring, reproductive health and aging, serving laboratories across a patients lifespan with its best in class diagnostic tests. For more information, visit www.asuragen.com.

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