How UC Irvine research and a father’s story are changing the timeline of care
By the time most families receive a formal autism diagnosis, the most important window for intervention has closed.
Still, vast parts of human biology remain unexplored and untouched. Not because we don’t understand their importance, but because we haven’t had the tools to reach them. That limitation is exactly what a new startup, based on UC Irvine research, hopes to overcome.
By the time most families receive a formal autism diagnosis, the most important window for intervention has closed. In the first years of life, a child’s brain forms more than a million new neural connections every second. This is a burst of neurological development that’s never repeated in our lives. This period is short, and once it’s over, the opportunity to intervene at the brain’s most malleable stage is gone. That missed window isn’t just a personal loss for families; it’s a failure of the current system. It’s this fleeting, foundational period that NeuroQure, a biotech company grounded in UC Irvine research, is trying to give back.
“Our goal is simple,” says Dave Justus, founder and CEO of NeuroQure. “We want to shorten the time to meaningful treatment.”
It’s a bold goal and perhaps one of the most consequential in pediatric neurodevelopment today. NeuroQure’s flagship product, ASD Insight, is the first clinical-grade, biology-based test designed to identify autism risk years earlier than traditional behavioral assessments. The current gold-standard for autism assessment is the Autism Diagnostic Observation Schedule (ADOS), a careful and labor-intensive evaluation based on how a child speaks, plays, and interacts. But these behaviors often don’t emerge clearly until age two or later. And after that come the waitlists. It’s often months, or sometimes years, before parents receive a formal diagnosis, and longer still before therapies begin. By then, the brain’s most flexible, formative stage is already closing.
This makes early screening especially important for families with a known history of autism, since genetics often play a key role. Because of this genetic link, if one child in a family is diagnosed with autism, the chances that a sibling will also be diagnosed are significantly higher. In the general population, about 1 in 36 children are diagnosed with autism. But for families with one autistic child, the likelihood that a sibling will also be diagnosed can rise to 1 in 5. This elevated risk is why early screening for younger siblings is often recommended, even before any behavioral signs appear.
“The science is really clear,” Justus explains. “If you can intervene by age two with occupational, physical, and speech therapy, it’s possible to increase a child’s IQ by 17 points. That could be the difference between special education and general education. That difference could be life changing.”
With ASD Insight, families can access risk information as early as birth. The test measures a biophysical marker, a measurable signal in the body that shows how cells are functioning (or not functioning) at the molecular level. Unlike genetic tests, which examine inherited DNA, biophysical markers reveal how the body is operating. NeuroQure’s test focuses on how cells process calcium, an element that plays a critical role in brain signaling, energy production, and early cognitive development.
The process starts with a small skin sample, typically a 3mm biopsy or discarded foreskin after circumcision. Scientists grow skin cells from that sample and measure how calcium moves in and out of the cells. In people with a higher likelihood of autism, those calcium signals tend to be weaker or disrupted. Research suggests this may reflect a form of metabolic stress in the brain, something that occurs long before behavioral symptoms emerge. The result is a biological snapshot that provides a way to assess autism risk years before symptoms typically emerge.
A Parent’s Perspective
For Justus, the motivation behind NeuroQure is personal. Before launching the company in 2023, he built a career scaling private equity–backed businesses. But at home, the challenges were different. His son, Tyler, had been diagnosed with Fragile X syndrome, a genetic condition that affects learning and development and is often associated with autism. His family’s experience revealed just how slow and fragmented the path to diagnosis and treatment can be.
Justus launched NeuroQure with the hope to change the timeline of care for children with neurodevelopmental disorders. Like many families, the Justuses spent years navigating what he calls a “diagnostic odyssey,” searching for answers about their son’s developmental delays. By the time they received a diagnosis, the most effective window for early support had already passed. The process wasn’t just slow; it was misaligned with how the brain actually develops. Justus saw a system that waited for visible symptoms, then made families wait again. NeuroQure was his attempt to change that, combining what he knew from building companies with what he had learned as a parent.
“That experience had a profound effect on me,” Justus says. “And when I saw the science that would become NeuroQure, it felt like more than an opportunity. It felt like a responsibility.”
After Tyler was diagnosed, Justus began raising money for autism research through a nonprofit he founded. That work led him to UC Irvine and to Professor Emeritus John Jay Gargus, from the Department Physiology and Biophysics, a longtime researcher of cellular signaling in autism and founding director of UC Irvine’s Center for Autism Research and Translation. Gargus’s emphasis on biology over behavior offered a rare approach in autism research. For Justus, the real breakthrough was seeing how that science could be applied in a meaningful way.
“That combination of academic depth and clinical relevance is rare,” Justus says. “It was something we could build into a tool to help families.”
Built on UC Irvine Research, Available Nationwide
Turning that discovery into a usable product took time. Moving from lab science to something that could be trusted in a clinical setting meant building new infrastructure and meeting rigorous regulatory standards. NeuroQure spent several years validating the ASD Insight test under CLIA, the federal certification required for diagnostic labs.
“It was a much bigger hurdle than we expected,” Justus says. “But we moved carefully because we knew this test needed to be trusted.”
In January 2026, NeuroQure launched ASD Insight nationwide. The test is now available in nearly every state and can be ordered through pediatricians or online, though it still requires a physician’s prescription. The test is currently paid out-of-pocket, but NeuroQure is working to broaden access. That means partnering with OB-GYNs and pediatricians, who are often the first to spot early developmental concerns. It also means working to secure broader insurance coverage so that access isn’t limited to families with resources. NeuroQure is looking at partnerships with employers, government insurance programs, and flexible payment options all aimed at closing the gap between scientific advancement and everyday accessibility. The challenge isn’t just scaling a test; it’s integrating it into a healthcare system in a way that ensures early detection is accessible to everyone.
“We’ve priced the test nearly at cost,” Justus says. “This is about getting the information to families.”
NeuroQure is still early in its journey. To date, the company is supported by founder capital and a group of mission-aligned investors who understand both the clinical need and long-term potential.
“We’ve been fortunate to bring in investors who share our mission, people who understand both the urgency for families and the long-term potential of what we’re building,” Justus says.
That work is built on a foundation of academic research, backed by over $30 million in philanthropic and institutional funding through UC Irvine’s Center for Autism Research and Translation. Gargus’s research forms the backbone of the company’s platform, with a long-standing focus not just on understanding autism broadly, but on decoding the cellular signaling dysfunctions at its core.
“We’re proud to bring this discovery from UC Irvine to families across the country,” Justus says.
Expanding Access
ASD Insight is NeuroQure’s first product, but the company’s ambitions go further. Its long-term focus is on developing targeted therapies that treat the biological roots of autism, not just its outward symptoms. The goal is to intervene at the cellular level, where disruptions in signaling and energy regulation appear to play a key role. By identifying and addressing those dysfunctions directly, NeuroQure aims to shift autism care from symptom management to biological intervention.
While most of that work remains confidential, NeuroQure is already pursuing early-stage research built on the same biological insights that power its diagnostic platform. The ability to measure autism risk at the cellular level is not just a breakthrough in detection, but it also lays the groundwork for therapies that address their biological source.
That combination of long-term potential and immediate clarity has struck a chord. The response so far has been strong. One parent described the test as the first time their concerns felt validated by science. Another parent shared that their child, now a young adult, had spent years misdiagnosed with bipolar disorder before finally being correctly identified as autistic. That clarification opened new treatment options and changed the course of their life.
“For families, it’s not about labels, it’s about clarity,” Justus says. “And that’s what this test provides.”
While NeuroQure won’t eliminate the deeply personal maze of autism care, it does offer something rare. It offers a way to act earlier, with clearer insight, at a time when a child’s brain is most open to change. The hope is that the long delays between concern and diagnosis will feel like a thing of the past.
“If a few years from now, families look back and wonder how we ever accepted such long waits to understand a child’s development,” he says, “we’ll know we made a real difference.”