MARAbio Introduces Blood Test For Maternal Autoantibody-Related Autism

MARAbio Systems (MARAbio) has commercially launched the MAR-Autism Test, the first blood test to identify specific maternal autoantibodies that are causal for an autism subtype. Maternal Autoantibody-Related Autism (MARA) has a clearly defined biological mechanism and is one of the most prevalent subtypes, estimated to account for up to one in five individuals with the condition.

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 culmination of more than two decades of research and work at the UC Davis MIND Institute by MARAbio Founder/Chief Scientific Officer Judy Van de Water, Ph.D. Identifying these distinct pathogenic autoantibodies represents a breakthrough in autism detection in a current or future child.

“With increased attention to autism and the societal demand to identify the underlying causes, many sets of hopeful eyes are following our work,” Dr. Van de Water said. “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.”

In clinical testing, the proprietary MAR-Autism Test demonstrated 99% or greater specificity for each individual MARA autoantibodies combination, ensuring a low false positive rate. 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 99% specificity.

U.S. healthcare providers can order the MAR-Autism Test for women with a previous child diagnosed with autism. 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, though it 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,” MARAbio President/CEO Michael Paul, Ph.D., stated. “Thanks to the 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.”

The MAR-Autism Test is available for eligible individuals by order through a doctor or other healthcare professional. In conjunction with the 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 autism subtype.

“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,” commented noted clinician and autism researcher Richard E. Frye, M.D., Ph.D.

MARAbio Systems Inc. is a precision immunology company with proprietary technology related to a distinct cluster of autoantibodies that lead to 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. The company aims 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 with participation by Autism Impact Fund, and an additional $1.7 million in subsequent closings from other investors including Mesa Verde Venture Partners.