MARABIO LAUNCHES FIRST-EVER BLOOD TEST FOR MATERNAL AUTOANTIBODY RELATED AUTISM

The MAR-Autism™ Test Identifies a Specific Biological Subtype of Autism

SALT LAKE CITY, Dec. 17, 2025 /PRNewswire/ -- MARAbio Systems (MARAbio), a precision immunology company dedicated to detecting, treating, and preventing Maternal Autoantibody Related Autism (MARA), has commercially launched the MAR-Autism Test, the first blood test to identify specific maternal autoantibodies that are causal for a subtype of autism. MARA has a clearly defined biological mechanism and is one of the most prevalent subtypes, estimated to account for up to 1 in 5 individuals with autism. Peer-reviewed research shows MARA autoantibodies are associated with both moderate and more severe symptoms in individuals with autism.

MARA is caused by maternal autoantibodies that cross the placenta, disrupt the developing brain, and cause neurodevelopmental alterations and autistic symptoms. The test is the result of more than two decades of research and work at the UC Davis MIND Institute by Judy Van de Water, PhD, MARAbio's Founder & Chief Scientific Advisor. The identification of these distinct pathogenic autoantibodies represents a breakthrough in the detection of autism in a current or future child.

In clinical testing, the proprietary MAR-Autism Test demonstrated specificity of 99% or greater for each individual combination of MARA autoantibodies, ensuring a low rate of false positives. Additional analyses demonstrate that presence of certain autoantibody patterns result in a 99% risk of an autism diagnosis in a mother's child with a corresponding specificity of at least 99%.

Healthcare providers throughout most of the U.S. are now able to order the MAR-Autism Test for women with a previous child diagnosed with autism, to give families answers in younger siblings or prior to future pregnancies. The MAR-Autism Test is also available to women with a child showing signs of autism, enabling earlier referral for diagnostic evaluation and treatment. The Company is currently validating the test for broader use among the general population. The MAR-Autism Test is not validated or offered for use during pregnancy.

"The commercial availability of the MAR-Autism blood test is a transformative advancement in the detection of autism, including the likelihood of autism in a future child," said Michael Paul, PhD, MARAbio's President & CEO. "Thanks to the pioneering scientific research of Dr. Van de Water and UC Davis, and the work of the MARAbio team, millions of families and their healthcare providers now have access to our blood test, which can identify a scientifically proven biological cause of autism that is significantly more prevalent than any single cause of syndromic autism, including Fragile X.  This positions MAR-Autism as one of the most substantial biological causes of autism identified to date. Our team is now working to expand public awareness of MARA and our MAR-Autism Test, while also broadening the test's availability and use among the general population."

Providing additional context, Dr. Van de Water said, "With increased attention to autism and the societal demand to identify the underlying causes, many sets of hopeful eyes are following our work. We launched MARAbio to help provide scientific answers and peace of mind for mothers and families, and to give their children an opportunity for the best possible outcomes."

Commenting on the potential impact of this launch for providers and families, noted clinician and autism researcher Richard E. Frye, MD, PhD, said, "With MARAbio's test now available, particularly for those families already touched by autism, we now have access to meaningful insights into this particular and prevalent cause of autism, including the likelihood of MARA in future children. It's an exciting advancement that brings science and compassionate healthcare together in a truly impactful way."

The MAR-Autism Test is available for eligible individuals by order through a doctor or other healthcare professional. For additional information about the MAR-Autism Test and ordering instructions for healthcare providers, visit marautism.com.

In conjunction with commercialization of its blood test, MARAbio is evaluating several therapeutic interventions to prevent fetal exposure to these pathogenic maternal autoantibodies, thereby limiting the incidence of this subtype of autism globally.

About MARAbio:

MARAbio Systems, Inc. (MARAbio) is a precision immunology company with proprietary technology related to a distinct cluster of autoantibodies that lead to Maternal Autoantibody Related Autism (MARA). The company's first product, the MAR-Autism™ Test accurately predicts the likelihood of MARA in a child through a simple blood test in the mother even before clinical symptoms are identified in her child. Mothers can be tested before pregnancy or at any time after giving birth. The Company's mission is to detect, treat, and prevent MARA, a subtype which has been shown to be associated with both moderate and more severe symptoms in individuals with autism.

MARAbio's initial investors included parents of children on the autism spectrum who sought to understand the biological cause of their child's autism. Those efforts have been further supported by additional investment , including $19.1 million in an initial Series A financing led by MAK Capital One LLC (MAK) with participation by Autism Impact Fund (AIF), and an additional $1.7 million in subsequent closings from other investors including Mesa Verde Venture Partners.

For more information, please visit www.marabio.com.

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SOURCE MARAbio