NeuroQure, a startup diagnostics medtech that formed in 2023, has launched a first-of-its-kind test that can identify autism risk at birth, allowing for earlier and more fine-tuned therapies at critical stages of neurodevelopment.
Dubbed ASD Insight, the test was first developed over a seven-year period at the University of California, Irvine’s Center for Autism Research and Translation at a cost of more than $14 million. NeuroQure acquired the patents related to technology for an undisclosed price the same year the company launched.
The test, which uses a skin sample from a child, can identify mitochondrial and neurotransmitter dysfunctions associated with autism, the company said in a Jan. 20 press release. The sample is then processed at a NeuroQure-certified lab with results available within weeks.
ASD Insight is seen by the company as a giant leap in helping redefine autism as a biologically measurable condition versus one that is diagnosed only by observation.
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“Autism is treatable, and research has demonstrated that early intervention significantly enhances cognitive, social, and behavioral development.,” John Gargus, M.D., Ph.D., founder and chief scientific officer at NeuroQure, said in a statement. “For years, our research has demonstrated that dysregulated calcium signaling is a unifying final common pathway leading to pathophysiological features across diverse autism genotypes.”
The test, he added, provides detection as early as birth of biophysical and metabolic dysfunctions at a cellular level before behavioral symptoms emerge.
It was Gargus’ work at UC Irvine on calcium signaling and mitochondrial dysfunction in autism that was the basis for the ASD Insight test.
Studies cited by the company show children that begin treatment of autism by age 2 have significant cognitive and social improvements, and new therapies are showing effective therapy can begin by 6 months. According to the Centers for Disease Control and Prevention, about 1 in 31 8-year-olds identified with ASD, an increase from earlier figures that indicated 1 in 44 or 1 in 36 in previous reports.
