The diagnostic tool identifies a specific biological cause of autism with more than 97% predictive accuracy.
MARAbio Systems has launched an updated blood test designed to identify specific maternal autoantibodies associated with a subtype of autism. The MAR-Autism Test can detect a greater than 97% risk of an autism diagnosis in a current or future child, according to the company.
The test focuses on Maternal Autoantibody Related Autism (MARA), a subtype estimated to account for up to one in five individuals with autism. The tool identifies a specific pattern of maternal autoantibodies that can cross the placenta and disrupt fetal brain development.
“This provides families and healthcare providers with a highly predictive and clinically validated test that identifies a specific subtype of autism, even prior to pregnancy,” says Michael Paul, PhD, president and CEO of MARAbio, in a release. “As a result, families can make better informed family planning decisions, obtain earlier treatments for their affected children, and one day benefit from future therapeutics to prevent the pathogenic effects of these autoantibodies.”
Clinical Validation and Accuracy
The updated MAR-Autism Test demonstrated more than 97% predictive accuracy for autism with 99.8% specificity in clinical validation, according to the company. This high specificity indicates a low rate of false positives.
The test is performed exclusively on the mother through a blood draw and can be conducted either prior to or after pregnancy. This distinguishes it from traditional autism assessments, which typically rely on behavioral evaluations or samples taken directly from the child.
“Families deserve something more than speculation – they deserve reliable, science-based answers they can trust,” says Paul, in a release.
Research and Development
The technology is based on more than 20 years of research, including work conducted at the University of California Davis MIND Institute. Immunologist Judy Van de Water, PhD, whose research first identified the pathogenic maternal autoantibodies associated with MARA, serves as the company’s founder and chief science advisor.
“For many families, one of the most difficult questions has always been why,” says Van de Water, in a release. “This research provides a scientifically grounded answer for a meaningful subset of autism cases.”
Market Context and Access
The availability of the test comes as the prevalence of autism continues to rise. The condition now affects one in 31 children, according to the latest report from the Centers for Disease Control and Prevention cited by MARABio Systems.
Healthcare providers across most of the US can now order the test for eligible mothers. The company has also implemented telehealth-enabled access to facilitate testing for women who may face logistical challenges or complex care coordination.
MARAbio aims to provide objective, biology-based autism risk prediction to help families answer questions about current or future children, particularly in cases where symptoms of developmental delay are already present.
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