NeuroQure, a biotech startup using patented technologies from UCI, just launched a test that will make it possible to identify the likelihood of autism spectrum disorder (ASD) at birth.
The CLIA-certified test, called ASD Insight, is said to be the first biological test for autism, giving families objective insight for the first time, said Dave Justus, chief executive of NeuroQure.
“Autism care has a huge bottleneck,” Justus told the Business Journal. “Often, families can’t reliably diagnose autism until well into the toddler years because the system is dependent primarily on observed behaviors.”
The average age of autism diagnoses in the U.S. is five years old, which is “long after critical development windows have passed,” according to Dr. John “Jay” Gargus, co-founder and chief scientific officer at NeuroQure.
The Irvine-based company aims to enable earlier prevention with ASD Insight.
Studies show that children who begin treatment by age two experience significant cognitive and social improvements with many achieving independent living and workforce participation, according to NeuroQure.
“Everybody in the industry agrees that the treatment strategy is to identify as early as possible because early intervention makes a massive impact,” Justus said.
Acquired Patent Portfolio from UCI CART
The breakthrough research behind NeuroQure’s test was discovered at UCI’s Center for Autism Research and Translation (CART) during Gargus’ tenure as director of the center.
Gargus and his team found the first biological marker, a defect in calcium signaling, that’s indicative of autism.
Children with a low calcium signal, which plays a large role in learning and development, were shown to have a high probability of ASD.
NeuroQure acquired a patent portfolio encompassing eight years of research in 2024. Now, two years later, it has commercialized its first product.
The company’s test collects a tissue sample, about three millimeters in size, from a skin punch biopsy or discarded foreskin, which is then sent to NeuroQure’s lab in Irvine for processing. Results are available within three to five weeks, according to Justus.
It’s currently available for purchase online for $949, which also includes genetic counseling and support for potential treatment plans for families post receiving results.
Justus said one of the company’s main goals for 2026 and 2027 is to obtain payer coverage for ASD Insight. In the meantime, NeuroQure is also working to make the test available through people’s health savings account (HSA) plans.
“We’re doing a lot of work to make the test affordable while waiting to get insurance coverage,” Justus said.
Aims to Replace Behavioral Tests
Justus said that physicians asking for ASD Insight “strongly encourage” families with a history of autism to get the test.
One in 31 children at eight years old have autism, according to Autism Speaks and the Centers for Disease Control and Prevention.
What may be lesser known, Justus said, is that family members with siblings who have been diagnosed are seven times as likely to get ASD.
The current standard for diagnosing ASD is an activity-based assessment administered by trained clinicians.
“While it’s considered the clinical gold standard, it’s a behavioral test, so they can’t begin to test it on kids until generally about two years,” Justus said.
NeuroQure’s test is a screen, not a diagnostic, but can be performed much earlier and its sensitivity and specificity is “very close” to the current gold standard, according to Justus.
Moving forward, Justus said that the company plans to continue to improve its science and “potentially generate more offerings.”
“I can’t get into the specifics of those right now, but we’re always aggressively working to advance science for these families that we’re serving all around autism,” Justus said.
