Intravenous Immunoglobulin (IVIg) Treatment May Benefit Some Children with Autism Spectrum Disorder

-- Biomarkers included on Moleculera Labs' Cunningham Panel™ shown to be helpful in identifying a subset of autistic children likely to benefit from IVIg therapy --

OKLAHOMA CITY, Sept. 12, 2018 /PRNewswire/ -- A subset of children with autism spectrum disorder (ASD), who have an immune abnormality, may benefit from intravenous immunoglobulin (IVIg) treatment, according to new research from Richard E. Frye, MD, PhD, Chief of Neurodevelopmental Disorders at the Barrow Neurological Institute at Phoenix Children's Hospital.

According to Dr. Frye and colleagues, this is the largest case series examining children with ASD who have been treated with IVIg. The article "Intravenous immunoglobulin for the treatment of autoimmune encephalopathy in children with autism" is published in the August issue of Translational Psychiatry. Using the Cunningham Panel™, the authors identified, for the first time, immune biomarkers that can predict with over 80% accuracy which children with ASD will respond favorably to IVIg treatment.

Recent studies have shown that some children with autism spectrum disorder have an immune system dysfunction. While the standard of care for ASD is behavioral therapy, individuals with a physiological abnormality, such as an immune dysregulation, may require more comprehensive medical treatment.

Dr. Frye, senior author and primary treating physician, states that "Our study demonstrated that a subset of children with autism spectrum disorder (ASD), particularly those that do not respond to standard interventions, may have autoantibodies that target brain tissue which might qualify them for the diagnosis of autoimmune encephalopathy."

The majority of ASD patients had elevated levels of these autoantibodies measured by the Cunningham Panel™ along with an elevation in the activation of calcium calmodulin dependent protein kinase II. However, very few patients had other brain targeted autoantibodies associated with autoimmune encephalopathy (AIE), such as voltage-gated calcium channels autoantibodies.

"Complex neuropsychiatric and developmental disorders may have different pathophysiological origins," says Dr. Craig Shimasaki, President and CEO of Moleculera Labs. "Therefore, it is essential to have laboratory evidence in order to direct treatment toward the underlying biology that is causing or contributing to symptoms. We are very pleased that Dr. Frye and his team were able to demonstrate this expanded clinical utility of the Cunningham Panel in children on the autism spectrum who would likely benefit from IVIg."

The authors examined 80 children diagnosed with ASD and AIE. IVIg was recommended for 49 of these patients, with 31 receiving treatment. Clinical notes and parent-reported outcomes were analyzed to determine improvement in symptoms, adverse effects and treatment course. IVIg was found to be beneficial with the majority of parents (90%) reporting some improvement in their child's symptoms.

About Moleculera Labs
Moleculera Labs is an autoimmune neurobiology company whose objective is to discover and deliver advanced clinical testing services for children and adults suffering from treatable autoimmune central nervous system disorders. The company's initial offering is the Cunningham Panel™, a set of tests aimed at assisting clinicians in the diagnosis of neuropsychiatric conditions associated with a variety of symptoms such as tics, OCD, anxiety, anorexia and behaviors associated with ASD, that are caused by an autoimmune response triggered by common infections.

Moleculera Labs is a technology spin-out from the University of Oklahoma and operates a fully-accredited CLIA (Clinical Laboratory Improvement Amendment) and COLA (Commission on Laboratory Accreditation) certified clinical laboratory in Oklahoma City where it performs the Cunningham Panel™ for physicians and clinicians throughout the United States and globally. For more information, please visit our website:

About Phoenix Children's
Phoenix Children's Hospital is Arizona's only children's hospital recognized by U.S. News & World Report's Best Children's Hospitals. For 35 years Phoenix Children's has provided world-class inpatient, outpatient, trauma, emergency and urgent care to children and families in Arizona and throughout the Southwest. As one of the largest children's hospitals in the country, Phoenix Children's delivers care across more than 75 pediatric specialties. Recognized specifically for its patient-focused innovation, medical education, growth and research, Phoenix Children's was named Business of the Year and Exceptional Innovator by the Greater Phoenix Chamber in 2018. For more information about the hospital, visit

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SOURCE Moleculera Labs


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