Moleculera Labs, Inc., a precision medicine, autoimmune neurobiology company, today announced the online publication of a study in the Journal of Neuroimmunology that shows a correlation between the accuracy and sensitivity of the Cunningham Panel™ results and symptom resolution in patients with an infection-triggered autoimmune encephalopathy. Autoimmune encephalopathy is an infection-triggered immune response against portions of the brain or nervous system which can result in a variety of neurologic or psychiatric symptoms.

The study, conducted by scientists from Moleculera Labs in conjunction with leading clinicians throughout the country, is entitled “Evaluation of the Cunningham Panel™ in Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infection (PANDAS) and Pediatric Acute-onset Neuropsychiatric Syndrome (PANS): Changes in antineuronal antibody titers parallel changes in patient symptoms.”

This case series included 58 patients diagnosed with PANS/PANDAS, an infection-triggered autoimmune encephalopathy, who were tested with the Cunningham Panel™ pre- and post-treatment and results were compared with their reported neuropsychiatric symptoms. The Cunningham Panel™ measures anti-neuronal antibodies against Dopamine D1 Receptor, Dopamine D2L Receptor, Lysoganglioside-GM1, Tubulin, and a cell-stimulation CaMKII assay and can provide clinicians with biological evidence supporting the diagnosis of an immune-mediated disorder, which may suggest alternative treatment modalities.

The study revealed a strong positive association between changes in neuropsychiatric symptoms and changes in the level of anti-neuronal antibodies directed against the brain and antibody-mediated CaMKII human neuronal cell activation measured by the Cunningham Panel™.

When the results were examined by changes in autoantibody and cell stimulation levels, the researchers observed an overall accuracy of 90%, a sensitivity of 88%, a specificity of 92%, and an AUC [Area Under the Curve] of 95.7%.

“The study findings support utility of the five assays comprising the Cunningham Panel™ to serve as an aid in a physician’s diagnosis of autoimmune encephalopathies, and provides an objective biological measure of treatment effectiveness,” said Craig Shimasaki, PhD, MBA, President and CEO of Moleculera Labs.

“For infection-triggered autoimmune encephalopathies there is a significant need to better understand the underlying disease mechanism and confirm biological targets that can improve patient identification and direct effective therapy,” said Shimasaki. “Validation of biological targets in patients with autoimmune neuropsychiatric conditions may ultimately lead to the development of more efficacious targeted therapeutics for treating patients with these disorders.”

For more information, see: study highlights and video of Dr. Shimasaki reviewing study findings.

About the Cunningham Panel™

The original research leading to the development of the Cunningham Panel™ was based on years of work conducted by Dr. Madeleine Cunningham and her laboratory team at the University of Oklahoma Health Sciences Center. The panel is available worldwide from Moleculera Labs, and can be ordered by licensed healthcare practitioners or clinicians authorized to order laboratory tests. For more information, please visit https://www.moleculeralabs.com/ordering-cunningham-panel-lab-tests/

About Autoimmune Encephalopathy

An aberrant immune response to human organs or tissues of the body can disrupt their normal biological function. An autoimmune encephalopathy is characterized by an immune response against portions of the brain or nervous system which can result in a variety of neurologic or psychiatric symptoms. Researchers believe that many chronic disorders which manifest in neuropsychiatric and behavioral symptoms, such as autism spectrum disorder, ADD/ADHD and many others, can be the result of an autoimmune encephalopathy. Other disorders such as PANS and PANDAS are infection-triggered autoimmune conditions that disrupt a patient’s normal neurologic activity, resulting in a sudden onset of obsessive compulsive disorder and/or severely restricted food intake. Symptoms can also include anxiety, emotional lability or depression, irritability, aggression, hyperactivity, memory deficits and cognitive changes, sensory or motor abnormalities, sleep disturbances and urinary problems.

About Moleculera Labs

Moleculera Labs is a privately-held precision medicine company focused on autoimmune neuropsychiatric disorders. The company’s objective is to discover and deliver advanced testing that points to targeted treatment for children and adults suffering from autoimmune central nervous system disorders. The Cunningham Panel™ is a set of tests that assist clinicians in their diagnosis of an autoimmune encephalopathy which can include PANDAS and PANS and other clinical conditions involving neuropsychiatric and behavioral symptoms such as those associated with autism spectrum disorders (ASD) and attention-deficit hyperactivity disorders (ADHD).

Researchers believe that portions of many neuropsychiatric conditions may be caused by an autoimmune response triggered by common infections. Moleculera Labs was spun out of the University of Oklahoma Health Sciences Center, and operates a full 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 www.moleculeralabs.com.