Autism Diagnostics Lab, a precision diagnostics company developing innovative and metabolomics-based tests designed to enable earlier autism detection, empower clinical decision-making, and improve outcomes for individuals with autism and their families, today announced the U.S. launch of the MDM™ Gut & Brain Health Test, the first commercial urine-based autism screening tool developed from research conducted at Arizona State University and published in Molecular Psychiatry, a Nature journal, identifying a distinct autism-associated biological signature measurable through a simple urine sample. Now available in the United States, the test is designed for children ages 2 years and older and is offered through Autism Diagnostics Lab’s CLIA-certified laboratory network.
The MDM Gut & Brain Health Test measures a proprietary panel of microbially derived metabolites (MDMs) identified in published research as biomarkers associated with autism-related gut-brain and metabolic signatures. In the published study, the MDM biomarker panel demonstrated 90% sensitivity and 100% specificity in distinguishing children with autism from typically developing controls. The technology was developed from research conducted in the laboratory of James Adams, Ph.D., President of Autism Diagnostics Lab and Professor at Arizona State University, building on over 25 years of investigation into the relationship between the gut microbiome, metabolism, and autism. Through a simple, non-invasive urine sample collected at home, the test analyzes metabolites produced by gut microbes and provides clinicians with objective biological information that may help identify children who could benefit from further developmental evaluation. Results are typically available within 7–10 business days.
“Despite growing awareness of autism, diagnosis still depends largely on behavioral assessments that can be difficult to access and often have long wait lists,” said Dr. Adams. “Our goal is to provide families and clinicians with objective biological information that may help identify children who are at high risk of autism and would benefit from further evaluation. The launch of the MDM Gut & Brain Health Test represents an important step in translating decades of research into a practical tool that can offer earlier insight and support more informed decisions about clinical care.”
“For decades, autism assessment has relied almost exclusively on observation of behavior,” said Christina Flynn, Ph.D., Research Director at Autism Diagnostics Lab. “Our findings demonstrate that biological signals associated with autism can also be detected through a simple urine sample. We believe this represents an important advance toward bringing objective biological measurements into autism screening and evaluation.”
The technology was informed by the participation of families whose experiences helped researchers evaluate the test’s potential role in supporting earlier autism screening.
“Like many families, we spent years searching for answers,” said Jolynn Price Rojas, whose son participated in the test development. “The information from this test gave us greater confidence in pursuing additional evaluations and support for our son. Earlier insight can make a meaningful difference because every month matters when you’re trying to help your child.”
The launch reflects Autism Diagnostics Lab’s broader commitment to advancing precision diagnostics through the integration of autism research, microbiome science, and clinical laboratory expertise. The company’s multidisciplinary team includes leaders in autism research, laboratory medicine, and biomarker discovery focused on developing innovative tools that improve access to earlier insights and screening opportunities.
The test is intended to support autism screening and risk assessment and is not intended to serve as a standalone diagnostic tool. Clinical diagnosis of ASD should continue to be made by qualified healthcare professionals using established diagnostic criteria and comprehensive evaluations.
