NeuroQure Launches First-Ever Functional Biophysical Marker Test for Autism, Transforming Early Autism Risk Diagnosis

ASD Insight Test is a Critical Step in Redefining Autism as a Biologically Measurable Condition

IRVINE, Calif.--(BUSINESS WIRE)--NeuroQure, a pioneering leader in neurological diagnostics, announces the launch of ASD Insight, a first-of-its-kind test designed to identify autism risk as early as birth. Representing a critical step in redefining autism as a biologically measurable condition, ASD Insight provides clinicians and families with unprecedented early insight into autism risk, enabling earlier, targeted interventions during the most critical stages of neurodevelopment.

“Autism is treatable, and research has demonstrated that early intervention significantly enhances cognitive, social, and behavioral development. However, the average age of autism diagnosis in the United States remains at five years, long after critical developmental windows have passed,” said Dr. John “Jay” Gargus, MD, PhD, Founding Scientist & Chief Scientific Officer at NeuroQure and Professor Emeritus of Physiology & Biophysics and Pediatric Medical Genetics & Genomics at the University of California, Irvine, where he also served as Founding Director of the Center for Autism Research and Translation.

It is Dr. Gargus’s pioneering work on calcium signaling and mitochondrial dysfunction in autism that laid the foundation for the ASD Insight test. Utilizing an advanced optical patch clamp technique, the test identifies mitochondrial and neurotransmitter dysfunctions associated with autism. NeuroQure’s CLIA-certified lab processes skin biopsy samples, providing clinicians with risk assessments within weeks.

“For years, our research has demonstrated that dysregulated calcium signaling is a unifying final common pathway leading to pathophysiological features across diverse autism genotypes,” said Dr. Gargus. “ASD Insight represents the first clinical application of this knowledge, enabling the detection of biophysical and metabolic dysfunctions at a cellular level before behavioral symptoms emerge, as early as at birth. It’s a critical step toward redefining autism as a biologically measurable condition rather than one diagnosed solely through observation.”

Studies show that children who begin autism treatment by age two experience significant cognitive and social improvements, with many achieving independent living and workforce participation, and new approaches are demonstrating that effective therapy can begin by six months. In contrast, delayed diagnosis and intervention can lead to increased dependency and higher lifetime medical costs.

“Simply put, early diagnosis means early treatment, and early treatment leads to brighter futures,” said David Justus, Founder & CEO of NeuroQure. “With this test, we can provide families with the knowledge they and their physicians need to make informed decisions about their child’s development from the very start, significantly impacting the trajectory of their lives.”

The test is now available at https://www.neuroqure.com/order.

About NeuroQure

NeuroQure develops molecular assays for neurological conditions, with an emphasis on early detection and risk assessment. The company applies scientific research to support healthcare providers in identifying neurodevelopmental disorders. For more information, visit https://www.neuroqure.com/.