NEW YORK (GenomeWeb) — Stemina Biomarker Discovery announced today that it has initiated a clinical study examining metabolism biomarkers for autism spectrum disorder (ASD) with the support of a $2.7 million grant from the National Institutes of Health.
Also funding the study is a $2.3 million investment from the Nancy Lurie Marks Family Foundation that Stemina received last year.
The trial, dubbed the Children's Autism Metabolome Project (CAMP), will enroll 1,500 subjects at six sites across the US with the goal of confirming that previously identified metabolic biomarkers can detect subtypes of ASD. Study participants will include children with autism, children without autism but with other neurodevelopmental disorders, and normally developing children.
CAMP builds on three pilot studies previously conducted in more than 500 children and is also designed to identify new biomarkers that may enable earlier diagnosis and better treatment of ASD. In preliminary studies, the company was able to distinguish patients with autism from typically developing children with 81 percent accuracy.
"Confirmation of findings from our previous … pilot studies would be an important step toward developing an early diagnostic marker of ASD," David Amaral, a researcher at the University of California, Davis, and Stemina collaborator, said in a statement.
"By diagnosing ASD based on the patient’s metabolism, we hope to understand what is different about the metabolism of children with ASD and each subtype compared to typically developing children," Stemina CEO Elizabeth Donley added. "This approach will open up a whole new frontier for understanding the disorder and how to treat it."