EarliTec Diagnostics, Inc.

05/12/2025

We’re excited to share a major milestone at EarliTec Diagnostics:
Enrollment is officially complete for both MEASURE-ASD clinical trials!

Since March 3, 2023, we enrolled 1,254 subjects across both studies — including 929 diagnostic subjects aged 31 months to 7 years. This clinical trial will demonstrate the potential for transformative efficiency in autism diagnosis.

This achievement would not have been possible without the incredible dedication of our research partners:
Cortica
Marcus Autism Center
A.J. Drexel Autism Institute
Southwest Autism Research & Resource Center
Cincinnati Children's
MUNROE MEYER INSTITUTE
Seattle Children's
UMass Chan Shriver Center
Vanderbilt University Medical Center
Thompson Center for Autism & Neurodevelopment
University of Iowa Health Care

This marks EarliTec Diagnostics’ third multi-center, blinded clinical trial. The first trial led to FDA Breakthrough Device Designation. The EarliPoint™ Evaluation System is FDA-indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children 16 to 30 months old who are at risk based on concerns from a parent, caregiver, or healthcare provider.

We’re one step closer to helping more families get answers earlier, when it can make the biggest difference.

04/10/2025

From data to diagnosis — with heart, purpose, and innovation.

We’re incredibly proud of our own Ella Swanson-Hysell, Product Manager at EarliTec Diagnostics, for being featured in Womanthology’s latest issue: "Learning Without Limits."

Ella’s journey is a masterclass in interdisciplinary brilliance — blending child development, data science, and software engineering to help revolutionize early autism diagnosis. Her story reflects what makes EarliTec Diagnostics special: a relentless focus on making the complex simple, the invisible visible, and life-changing support accessible to every child, everywhere.

In the article, Ella shares:

How she helped transform clinical research into the FDA-cleared EarliPoint™ Evaluation What it takes to design technology for young children and with equity in mind

Why diversity in tech development isn’t optional — it’s essential Read Ella’s inspiring profile here https://www.womanthology.co.uk/innovating-autism-diagnosis-with-technology-a-journey-of-passion-and-purpose/

Congratulations, Ella! Your passion is helping more families get answers earlier — when it matters most. For information on EarliPoint™ Evaluation Visit: https://earlitecdx.com/

04/02/2025

Today is World Autism Awareness Day.

If You Could See Your Child’s Future…Would You Wait Or Take Action Today?

Every child sees the world differently—and sometimes, that difference is a sign that support is needed early.

With EarliPoint™, you don’t have to wait for answers.
✅ FDA-cleared
✅ Objective
✅ Available for children as young as 16 months

Early clarity means earlier support—and a brighter path forward.

🔗 Visit https://earlitecdx.com/parents-caregivers to learn how your child sees the world.

02/11/2025

Attention NE Florida and SE Georgia residents…

01/22/2025

“Hope for Families Facing Severe Autism Challenges”

Many families in the autism community face overwhelming challenges, especially when dealing with severe and self-injurious behaviors. The renewed Autism CARES Act of 2024 is a game-changer, providing $2 billion in funding over five years to support groundbreaking research, early interventions, and systemic solutions to improve care for individuals with autism.

Dr. Nathan Call from the Marcus Autism Center shares how this transformative legislation is already making an impact—offering hope for families and improving outcomes through tailored interventions, better training for professionals, and addressing critical barriers like insurance, transportation, and housing.

Learn how these advancements are shaping a brighter future for individuals with severe and challenging autism behaviors.

👉 Read the full story here: https://www.autismspeaks.org/blog/hopeful-future-overlooked-group-autistic-community?fbclid=IwZXh0bgNhZW0CMTEAAR1N_MxM3I1rQqVP-I45SeXdBm56sENaQWrEZtgPw_FJKgRj62yUC0EyASk_aem_Q5z-WNrOZSPGY0efvSyWWQ

📢 Share this with parents or caregivers who need to know they are not alone in this journey.

Dr. Nathan Call explains how the Autism CARES Act of 2024 is advancing research and care for severe and challenging autism behaviors.

06/11/2024

🌟 Join Us for an Exclusive Continuing Education Event! 🌟
Are you a clinician, therapist, parent, or educator dedicated to fostering optimal developmental outcomes in toddlers? Don't miss our upcoming one-hour course on the revolutionary EarliPoint diagnostic tool!

📲 REGISTER TODAY! https://hopehavenassocinc.wufoo.com/forms/k11i1zbk0042t97/

📅 Date: Thursday, June 13, 2024
⏰ Time: 12:00 PM - 1:00 PM
📍 Hope Haven, 4600 Beach Blvd, Jacksonville, FL 32207
🖥️Also available virtually.

During this session, we will:
✅ Review the evidence basis for EarliPoint
✅ Describe the assessments and data it provides
✅ Explore its future applications in identifying potential developmental delays in toddlers

Why Attend?
🔹Learn from Dr. Allison Cato, an expert in early ASD diagnostics
🔹Gain insights from real-world case examples
🔹Stay ahead with the latest advancements in the field

Join us at Hope Haven and make a difference in early childhood development!
📲REGISTER TODAY! https://hopehavenassocinc.wufoo.com/forms/k11i1zbk0042t97/

05/20/2024

The Munroe-Meyer Institute at UNMC will be the first facility in Nebraska to use a new tool to detect autism in young children, in a clinical setting, beginning next month.

05/20/2024

Many families have to wait months, even years, to get their children evaluated for autism, but now some are getting a successful diagnosis in half the time thanks to a new tool.

05/20/2024

We love seeing this from our customers!

News Alert: Easterseals Southwest Florida Brings Groundbreaking Eye Tracking Technology to Southwest Florida, Revolutionizing the Treatment of Autism Spectrum Disorder

The intersection of technology and healthcare has taken a leap forward with the introduction of cutting-edge eye tracking technology aimed at transforming the way that Autism Spectrum Disorder (ASD) is perceived and addressed. Developed by EarliTec Diagnostics, Inc., this innovative solution, is an FDA-authorized tool that promises to revolutionize the diagnosis, assessment and understanding of ASD and Easterseals Southwest Florida is utilizing this technology to diagnose ASD earlier in children.

Autism Spectrum Disorder affects approximately 1 in 36 children, presenting unique challenges in communication, social interaction and behavior. One of the key diagnostic markers of ASD lies in differences in social visual engagement. Current diagnostic methods often rely on standardized behavioral observations by expert clinicians, which may lead to delays in diagnosis. However, the emergence of eye tracking technology, such as EarliPointTM, has opened the way for early detection and intervention. Using this technology can effectively and accurately aid in diagnosing and assessing autism in children as young as 16- to 30- months old.

“EarliPointTM eye tracking technology represents a paradigm shift in the way we approach diagnosing autism spectrum disorder,” said Dr. Jena Lieb, PsyD, Clinical Psychologist at Easterseals Southwest Florida. “By using these digital biomarkers, we are provided objective measurements of social visual engagement that pave the way for earlier diagnoses, reduced waitlist time, more personalized assessments and can effectively start treatments earlier,” she added.

Key features of EarliPointTM tracking technology include:

1. Precision and Sensitivity: The system can detect even the slightest deviations in eye gaze, providing clinicians with highly accurate diagnostic information.
2. Real-time Feedback: By offering real-time feedback on eye gaze behavior, therapists can tailor interventions to address specific deficits in social communication and interaction.
3. Objective Metrics: Metrics derived from eye tracking data eliminate subjectivity in assessment, leading to more reliable diagnoses and treatment plans.

“It’s important to bring this type of technology to our area to provide a quicker and more objective diagnosis of autism spectrum disorder, even in children as young as 16 months,” said Nicole Murby, MS, CCC-SLP, Vice President of Programs, Easterseals Southwest Florida. “The sooner a child can be diagnosed, the sooner Easterseals can assist the family with treatment options and supportive resources. We are excited to have launched this new technology”.

For more information about Easterseals diagnostic service, please call 941-355-7637

05/10/2024

We're proud of the Edison Silver Award that EarliPoint was recently awarded. Pictured here with co-founder Dr. Warren Jones of the Marcus Autism Center.

We are incredibly proud of our very own Dr. Warren Jones, Director of Research at the Marcus Autism Center, and his team for their EarliPoint Evaluation tool, which was awarded a silver prize in the 2024 Edison Awards Health, Medical & Biotech category. The EarliPoint Evaluation tool is the first-of-its-kind advancement that helps clinicians diagnose and assess autism for children ages 16 to 30 months of age. Learn more at https://edisonawards.com/2024-winners/.

02/26/2024

If you know a child 15-78 months of age living in or around Atlanta, Cincinnati, Los Angeles, Philadelphia, Phoenix, San Francisco, or Omaha, please consider our clinical trial. Children will watch videos using the EarliPoint System to evaluate verbal and non-verbal learning and social disability. Qualified participants will receive frequent developmental assessments and study-related compensation. Learn more at www.earlitecdx.com/MEASURE_ASD

02/22/2024