A New Era in Early Autism Support: LinusBio and Autism Speaks Partner to Promote Earlier Autism Diagnosis and Intervention

Partnership will utilize ClearStrand-ASD — LinusBio’s first-in-class biochemical test that identifies a molecular signature predictive of autism in a strand of hair

LinusBio, a leader in precision exposome medicine, and Autism Speaks, the leading research and advocacy organization dedicated to supporting the autism community, today announced a partnership to advance early autism diagnosis and intervention. As part of the collaboration, Autism Speaks will provide educational materials and resources to families concerned about autism, helping them better understand the potential of biomarker testing for earlier detection. To further support accessibility, Autism Speaks will also offer ClearStrand-ASD — LinusBio’s innovative biomarker test — at a reduced cost to families in need. LinusBio will additionally support Autism Speaks’ ongoing community initiatives.

This joint effort will directly power two major Autism Speaks initiatives: The first is the Autism Response Team (ART) — Autism Speaks’ frontline support system that connects the autism community to trusted information and resources. Through this partnership, ART will share educational materials about ClearStrand-ASD and provide exclusive discount codes, helping families access the latest advancements in biomarker testing for autism. The second initiative is the Empower Summit & Challenge — a series of two-day events launching this spring in five U.S. cities. These events bring together autistic individuals, families, service providers, and policymakers to address some of the most pressing issues facing the community. At each summit, LinusBio will host an interactive space within the resource fair, offering families a hands-on opportunity to learn more about the cutting-edge science behind ClearStrand-ASD and how it may support earlier diagnosis and intervention.

“Autism Speaks is the leading organization in the U.S. focused on research and advocacy to support the autism community, and we are proud to partner with them to advance improved outcomes through innovation,” said Dr. Manish Arora, founder and CEO at LinusBio. “Together, we aim not only to raise awareness among families, healthcare providers, and clinicians about the benefits of biomarker testing for autism — and how it can support earlier diagnosis and intervention — but also to make a tangible, immediate impact for families currently seeking answers.”

Early diagnosis and interventions are key to better long-term outcomes, but many families still encounter lengthy delays in accessing the diagnostic support they need. ClearStrand-ASD offers a powerful new tool to support healthcare providers and caregivers during a critical window — ages 1 month to 36 months — when early intervention may be most effective. This partnership marks a major milestone in connecting families to essential healthcare resources when they need them most.

“At Autism Speaks, we’re committed to supporting innovative research that could lead to earlier identification and more personalized care for people with autism,” said Dr. Andy Shih, Chief Science Officer at Autism Speaks. “Our collaboration with LinusBio is focused on evaluating a promising diagnostic technology through rigorous, community-based research. By supporting participation of patients and their families through educational information from our Autism Response Team, we hope to ensure the tool could benefit a large and diverse population so that it may one day improve access to earlier diagnosis for families in need.”

“For most of my life, I was misdiagnosed or dismissed. Getting an autism diagnosis as an adult finally gave me the answers I had been searching for,” said Victoria Handy, an Autism Speaks Champion of Change. “That experience changed how I see myself — and how I support my daughter, who is also autistic. Every family deserves the chance to understand sooner. That’s why partnerships like this one matter. Tools like ClearStrand-ASD can give parents a head start on what I didn’t have: answers early enough to truly help make a difference.”

ClearStrand-ASD must be ordered by a licensed health care provider. LinusBio enables caregivers to request the test from home through an independent telehealth provider. The test is intended for infants and toddlers who are at an elevated risk of autism, such as those who were born preterm, who have a sibling with autism, or who have demonstrated characteristics associated with autism. If the test does not detect the biomarker, it is unlikely the child has autism. If the test does find the biomarker, the child may need further professional evaluation. ClearStrand-ASD now available at www.clearstrandasd.com.

About LinusBio

LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in North Brunswick, NJ. The Company’s program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology. For more information, visit www.linusbio.com.

About Autism Speaks

Autism Speaks is dedicated to creating an inclusive world for all individuals with autism throughout their lifespan. In response to the pressing needs of the 1 in 31 children and 1 in 45 adults with autism in the U.S. today, Autism Speaks provides resources and tools for autistic individuals of all ages and levels of support. Connecting millions of people with autism and their families to free services, supports, research, innovation and advances in care, the nonprofit serves as a convener for the autism community with the goal of making a real difference for all people on the autism spectrum. Learn more and join the movement by following @AutismSpeaks on social media.

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“Autism Speaks is the leading organization in the U.S. focused on research and advocacy to support the autism community, and we are proud to partner with them to advance improved outcomes through innovation,” said Dr. Manish Arora, CEO at LinusBio.