Quadrant Biosciences Inc, Syracuse, NY, a developer of novel diagnostic technologies, has been awarded a $2 million phase II small business technology transfer (STTR) grant from the National Institutes of Health (NIH) for the refinement and commercialization of an epigenetic diagnostic for autism spectrum disorder (ASD). The collaborative award follows the company’s successful phase I findings and will support the ongoing work of investigators Frank Middleton, PhD, at SUNY Upstate Medical University, Steven Hicks, MD, PhD, at Penn State Hershey Medical Center, and Alexander Rajan, PhD, at Quadrant Biosciences.

ASD is a medical condition that affects a person’s communication abilities and social skills, and often causes repetitive patterns of behavior and a narrow range of interests. Approximately 1 in 59 American children are currently diagnosed with ASD, a 10-fold increase in prevalence over the past 40 years.

“ASD can have a profound impact on families,” says Richard Uhlig, founder and CEO of Quadrant Biosciences. “While the cause of the disorder is unknown, early treatment of the symptoms can significantly improve the lives of affected children. Unfortunately, the first step in the process—diagnosis—is often delayed. Our collaborative team has developed an epigenetic test designed to facilitate the early diagnosis of ASD, thereby accelerating access to treatment.”

Independent NIH reviewers gave Quadrant’s ASD technology and grant proposal high praise, with one reviewer referring to the novel diagnostic approach as “game changing.” STTR grants are intended to facilitate the translation of promising technologies to the private sector and ultimately provide beneficial healthcare innovations to consumers. Middleton sees this objective manifested in the partnership between Quadrant Biosciences and the two universities.

“I am delighted by the strong endorsement of the research program that Steve Hicks and I established with Quadrant Biosciences 3 years ago to pursue development of the ASD diagnostic tool,” says Middleton. “Quadrant Biosciences has made a major investment and commitment to helping those with autism, and this transformative technology represents a significant step forward in that direction.”

“This grant will allow us to validate epigenetic technology with the power to dramatically advance autism assessment,” adds Hicks. “I am honored to play a part in this groundbreaking work.”

Quadrant and the company’s collaborators recently completed an NIH-funded phase I study that included more than 500 children aged 18 months to 6 years and utilized RNA features to differentiate children with ASD from peers with typical development or developmental delay. The diagnostic accuracy of the technology exceeded 85%. The promising results of the study encouraged Quadrant Biosciences to seek additional NIH funding to further develop and confirm the efficacy of an easily administered epigenetic test.

The phase II study expands enrollment to five different academic medical centers around the United States, including recruitment of 750 additional children. As in the phase I study, the phase II study includes not only ASD and typically developing children but also children with developmental delays that are often difficult for clinicians to distinguish from ASD.

“While our results thus far have been very promising, further evaluation is always warranted,” notes Randall Carpenter, MD, executive director of clinical development at Quadrant Biosciences. “We are grateful to the NIH and for their decision to support our research, and look forward to advancing our technology.”

To learn more, visit Quadrant Biosciences.