Rewriting the Autism Timeline: Dr. Ami Klin of EarliTec on Making Early Diagnosis Possible

For families seeking answers, early childhood developmental delays can feel like a waiting game with no clear start — or finish. Traditional autism evaluations often take months to access, hours to complete, and weeks to return results. But early diagnosis isn’t just a clinical milestone — it’s the key that unlocks meaningful, life-changing intervention during the most critical windows of brain development.

That’s the problem EarliTec Diagnostics was built to address. Co-founded by Dr. Ami Klin, one of the world’s leading autism researchers, EarliTec is redefining what early autism assessment can look like: fast, objective, portable, and accessible — without compromising clinical rigor. After decades of NIH-backed science and multi-site trials published in JAMA, the result is EarliPoint — the first FDA-cleared medical device to aid in the diagnosis of autism using eye-tracking technology in toddlers as young as 16 months.

Ami Klin is Director of the Marcus Autism Center at Children’s Healthcare of Atlanta, Chief of the Division of Autism & Developmental Health at Emory University School of Medicine, and a Georgia Research Alliance Eminent Scholar. He’s also the founder of a movement to make autism care more timely and rooted in science. In the Q&A below, Dr. Klin reflects on the moments that inspired EarliTec, the lessons of bringing a diagnostic device to market, and what it takes to translate early science into lasting outcomes for kids and families.

Enjoy the conversation below.

Could you share the “aha” moment that sparked EarliTec Diagnostics? Was there a personal experience, a gap in the market you noticed, or a moment in a lab where you realized, “This could really help a lot of people”?

AK: There were, in fact, three moments — each separated by about eight years.

First Moment: A little girl gave us the idea.

In 2004, we saw a 16-month-old girl for a clinical evaluation. Because her older brother had autism, her pediatrician had been monitoring her development and referred her to us. You could be two inches from her eyes, and she appeared not to see or engage with us. If she looked at our eyes, it was as though she was staring at her own reflection in them. She was happiest alone, and it was almost as if we weren’t even there.

Some clinicians observing her from behind a one-way mirror questioned whether she was blind. But then, all of a sudden, she crawled quickly across the room — about six feet — to grab a tiny M&M on the floor. She hadn’t noticed our eyes inches away from her, but she certainly saw that candy. She was fully oriented to the world of things and appeared oblivious to the world of people. That was the environment she was developing in, and those were the experiences her brain was learning from. Warren and I became obsessed with the need to “see the world through this little girl’s eyes.”

Over the next few years, we developed specialized eye-tracking technology and a methodology to do just that — not only for her, but for hundreds of autistic children.

Second Moment: “Omg, our science could maybe solve a major public health problem.”

Around 2012, the benefits of early identification, diagnosis, and treatment were becoming clearer through our research and that of others. At the same time, our methods for analyzing eye-tracking data began to show promising results, including a second publication in Nature — one of the most prestigious scientific journals in the world. That convergence led us to a realization: we might be able to leverage our science to address the severe lack of access to early diagnosis.

At the time, it was becoming painfully clear that more than 1 in 5 children with autism weren’t being diagnosed early — representing an enormous missed opportunity to change the course of their lives. We thought: maybe we could build a mobile, objective, and cost-effective device to make diagnosis more accessible. At that point, clinical evaluations were time-consuming, expensive, and could only be done by experts in specialized centers.

Each year, more than 100,000 children are born in the U.S. who will have autism — but the number of specialized clinicians is far too small, and most have multi-year waitlists. That urgent public health need, combined with the progress of our science, led us to the idea of building a diagnostic device. In 2012, after moving from Yale to the Marcus Autism Center, we built a machine shop next door and began developing the first prototype.

Third Moment: “Omg, this is working!”

After completing large, national, multi-site trials with more than 1,600 toddlers, Warren walked in with our first batch of analyses. The trials had succeeded. The biomarker we developed was performing exceptionally well, with successful replication across three separate studies. It was strong enough to pass the rigorous scrutiny of FDA scientific review. It looked like we had developed the first-ever medical device for the early diagnosis and assessment of autism. Now, the challenge was making it portable and bringing it to the families who needed it — where and when they needed it. That meant launching a mission-driven company. And that’s how EarliTec was born.

By that time, we had received support from the NIH, the Simons Foundation, Bernie Marcus, the Whitehead Foundation, and the Georgia Research Alliance. But launching a company required a different kind of investment — not in science, but in product. That’s when Bernie Marcus stepped in again, becoming the sole investor and making the launch of EarliTec possible in 2020.

For those of us not steeped in medical diagnostics, can you paint a picture of how EarliTec’s technology works in a real-world scenario? Imagine a parent worried about their child’s developmental milestones — what does your technology look and feel like for them?

AK: Before, a parent might wait months — or even years — to access a clinician who could evaluate their child for autism. The evaluation might take several hours, sometimes across multiple sessions, and the final report could take another month.

Now, the process looks very different. The child simply watches a set of videos — showing children playing together — on an iPad-sized device. The clinician receives a detailed clinical analysis on the same day, with the answers the parent has been seeking — and more. The report includes the child’s diagnosis and pinpoints where they fall on the autism spectrum. It also provides insights into their level of social disability, language development, and non-verbal learning. This information is critical to designing an appropriate treatment plan — tailoring the intensity and type of intervention needed. Most importantly, it allows clinicians to spend more time with the family, walking them through the results and guiding them on next steps. No more long, excruciating waits. The earlier intervention begins, the more likely a child is to benefit from it.

From your perspective, why is early detection of developmental or cognitive conditions so critical?

AK: Our science shows that autism is not a disease — it’s a genetic trait that may result in disability, sometimes profoundly. Autism emerges from a developmental trajectory that diverges from typical development. From the earliest weeks and months of life, children with autism miss thousands of social learning opportunities. By their second year, what began as a deviation from the norm often manifests as symptoms — along with language delays and learning differences.

The later a child is diagnosed, the further they drift from typical development. Symptoms become more severe, treatments more intensive and expensive, and outcomes worse.

At our center, we’ve followed hundreds of high-likelihood infants from birth — tracking them monthly. We’ve seen many children who, after receiving early intervention, were no longer developmentally delayed by age 3. They may still carry the autistic trait, but it no longer causes the kind of disability we traditionally associate with autism. These children are able to thrive in inclusive environments, contribute creatively to society, and form meaningful relationships. The evidence is clear: earlier is better.

What’s one big challenge EarliTec Diagnostics faced, and how did you get through it?

AK: Unlike other areas of medicine, behavioral and mental health conditions — especially autism — haven’t had diagnostic biomarkers. The idea of getting FDA clearance for one was incredibly ambitious. But without it, we knew there’d be no viable path to broad clinical adoption.

FDA scientists understood the magnitude of what we were proposing. The evidence from our multi-site trials had to be crystal-clear, rigorously validated, and free of flaws. We were making an extraordinary claim, and we needed extraordinary evidence to back it up. In the end, our data were published in two simultaneous articles in JAMA and a JAMA-affiliated journal — the most widely read medical journals. Like the FDA, JAMA understood the weight of publishing our results. Never before had a set of clinical trials been reviewed so thoroughly.

What’s next for EarliTec? What milestones are you most excited to reach?

AK: EarliPoint has already transformed the way we diagnose and assess young children. Now, our focus is on treatment. We’ve completed large clinical trials to determine whether we can also measure response to treatment. That would allow us to better tailor therapies to each child. These same trials aim to expand our use case to children up to age 8. At the same time, we’re tackling another critical need: screening. Pediatricians are required to screen children for autism, but current methods miss more children than they catch. That delay in referral to diagnosis causes real harm. We’re currently testing EarliPoint as a population-based screener — a step upstream in the care pathway.

If EarliPoint can serve as a tool for screening, diagnosis, and monitoring treatment, we have the chance to build an entire care platform around it. That could address one of the most frustrating challenges for families: the fragmentation of care. Right now, screening doesn’t guarantee access to diagnosis, and diagnosis doesn’t guarantee access to treatment. Our vision is to change that — to build a healthcare ecosystem where families move seamlessly from concern to care, optimizing each child’s potential from the start.

Is there a particularly meaningful success story that stands out — one that captures the heart of EarliTec?

AK: Yes — our very first clinical patient to use EarliPoint. She was an 18-month-old toddler. Her family, with limited resources, drove more than two hours to the Marcus Autism Center. The child had a clear presentation of autism and was extremely difficult to engage. Ordinarily, she would have needed several visits to complete a clinical evaluation. But during a single visit, using EarliPoint, we had a clear diagnostic tool to help the clinicians spend the rest of their time supporting the family and planning early intervention. The gratitude of that family will stay with me forever. They got answers promptly — and could begin focusing on their daughter’s future. That little girl will now have a better life, and so will her family.

What inspired you to partner with Venture Investors Health Fund, and how have they shaped EarliTec’s journey?

AK: Our mission is to solve a massive public health challenge: the lack of access to early diagnosis. Without early diagnosis, early intervention isn’t possible. To succeed, we have to challenge long-standing, fragmented, and often dysfunctional healthcare systems. That’s not easy. Venture Investors Health Fund embraced that challenge with us. They’ve been true partners — boldly investing in a new future for families navigating autism. Their innovative mindset and entrepreneurial spirit made them a natural fit for this mission.

What advice would you give to other healthcare or diagnostics founders who want to make a real-world impact?

AK: Many scientists believe that once they’ve published their data and proven their solution, the problem is solved. But in truth, that’s just the beginning. Disseminating and embedding new tools in the real world — especially in systems resistant to change — requires a completely different skillset. It requires partnerships with like-minded entrepreneurs who understand adoption, access, and the realities of medical practice. Even the best scientific solution won’t matter if it can’t succeed in a world where payer systems incentivize obstacles over access, and where providers focus more on the children they do see than the ones they can’t. My advice: find your people. You won’t realize your vision without the right partners by your side.

Learn more at earlitecdx.com.