LinusBio, a precision exposome medicine company, and Autism Speaks, the leading autism research and advocacy organization, announced a strategic partnership aimed at advancing early autism diagnosis and intervention through innovative biomarker testing.
The collaboration centers around ClearStrand-ASD, LinusBio's first-in-class biochemical test that identifies molecular signatures predictive of autism spectrum disorder (ASD) by analyzing a strand of hair. The test targets a critical developmental window—from 1 month to 36 months of age—when early interventions are considered most effective.
Partnership Initiatives
Under the partnership, Autism Speaks will provide comprehensive educational materials to families concerned about autism, helping them understand the potential benefits of biomarker testing for earlier detection. To improve accessibility, Autism Speaks will offer ClearStrand-ASD at reduced costs to families in need, while LinusBio will support the organization's community initiatives.
The collaboration will directly power two major Autism Speaks programs:
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The Autism Response Team (ART), which serves as the organization's frontline support system, will share educational materials about ClearStrand-ASD and provide exclusive discount codes to help families access the test.
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The Empower Summit & Challenge, a series of two-day events launching this spring across five U.S. cities, where LinusBio will host interactive spaces within resource fairs to educate families about the science behind ClearStrand-ASD.
"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."
Addressing Diagnostic Delays
Early diagnosis and interventions are widely recognized as key factors in improving long-term outcomes for individuals with autism. However, many families encounter significant delays in accessing diagnostic support, with evaluation waitlists often extending months or even years.
ClearStrand-ASD aims to provide healthcare providers with an additional tool to support earlier identification, particularly for children at elevated risk of autism, such as those born preterm, those with siblings on the autism spectrum, or those exhibiting characteristics associated with autism.
Dr. Andy Shih, Chief Science Officer at Autism Speaks, emphasized the importance of this collaborative approach: "At Autism Speaks, we're committed to supporting innovative research that could lead to earlier identification and more personalized care for people with autism. Our collaboration with LinusBio is focused on evaluating a promising diagnostic technology through rigorous, community-based research."
Patient Perspective
Victoria Handy, an Autism Speaks Champion of Change who received her own autism diagnosis as an adult, highlighted the personal impact of diagnostic delays: "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. That experience changed how I see myself—and how I support my daughter, who is also autistic."
She added, "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."
How ClearStrand-ASD Works
The ClearStrand-ASD test must be ordered by a licensed healthcare provider, though LinusBio enables caregivers to request the test from home through an independent telehealth provider. The test is specifically intended for infants and toddlers at elevated risk of autism.
According to LinusBio, if the test does not detect the autism-associated biomarker, it is unlikely the child has autism. If the biomarker is detected, the child may need further professional evaluation to confirm a diagnosis.
Autism Prevalence and Impact
Current statistics indicate that autism affects approximately 1 in 31 children and 1 in 45 adults in the United States. The condition presents along a spectrum, with individuals requiring varying levels of support throughout their lives.
Early intervention services, which may include behavioral therapy, speech therapy, and occupational therapy, have been shown to significantly improve developmental outcomes when initiated during the first few years of life—precisely the window that ClearStrand-ASD targets with its testing capabilities.
The partnership between LinusBio and Autism Speaks represents a significant step toward combining innovative diagnostic technology with established community support networks to address one of the most pressing challenges in autism care: timely identification and intervention.
ClearStrand-ASD is now available through healthcare providers or via the company's website at www.clearstrandasd.com.
