NeuroPointDX Announces Validation of First-Generation Autism Diagnostic Panel

Share Article

The neurodevelopment diagnostic division of Stemina Biomarker Discovery has validated 12 metabolic subtypes of autism spectrum disorder. The diagnostic blood test for ASD will be available later this year.

The Children's Autism Metabolome Project, or CAMP, enrolled over 1,100 children at eight clinical sites across the country.

This is a historic moment, not just for Stemina and NeuroPointDX, but for our knowledge and understanding of autism.

NeuroPointDX, the neurological disorders division of Stemina Biomarker Discovery, announced today that it has validated a first-generation autism diagnostic blood test panel in the Children’s Autism Metabolome Project (CAMP), its clinical study. The study has enrolled 1,100 children, age 18-48 months, over the course of two years. CAMP is the largest study ever conducted that examines the metabolism of children with autism spectrum disorder (ASD).

“We’re so proud of the work our eight clinical sites have done to recruit very young children and their families to participate in CAMP. This tightly-designed study requires a first-of-the-morning blood draw, behavior and cognitive assessment, and medical examination. The quality of the work done at these sites deserves recognition.” said Elizabeth Donley, NeuroPointDX’s CEO.

NeuroPointDX’s first-generation autism diagnostic blood test was validated using patient samples from the $6 million CAMP study. “A manuscript is in progress and will be submitted to a peer-reviewed scientific journal by the end of January,” said Donley. “It is not an exaggeration to say that NeuroPointDX will revolutionize diagnosis and precision medicine. By identifying imbalances in the patient’s metabolism, we can diagnose neurological disorders and identify targeted treatments. These interventions may be as simple as modifying diet or dietary supplements, or as complex as developing new drugs to correct the imbalance.”

The test will be available this year and delivered by Stemina’s CLIA laboratory in Madison, Wisconsin. Families of children with suspected developmental delay are encouraged to ask their pediatrician about NeuroPointDX’s ASD panel once the test becomes available.

“Much like cancer consists of many distinct types, neurological disorders like autism can be best understood by looking at how an individual child’s symptoms present and what exacerbates them. Our research shows that how some children process certain amino acids can tell us a lot about how to help that child thrive. We have validated 12 metabolic subtypes of ASD, which together account for approximately 30% of children with autism, in our first-generation panel,” Donley said. “This is just the beginning of what we expect to learn from the CAMP study. This is an historic moment, not just for Stemina and NeuroPointDX, but for our knowledge and understanding of autism.”

Stemina was awarded a $2.7 million grant from the National Institute of Mental Health (NIMH) in August 2015 to support the CAMP study. The study is also supported by a $3.8 million investment from the Nancy Lurie Marks Family Foundation (NLMFF). The clinical sites are the MIND Institute at the University of California-Davis, Arkansas Children’s Hospital Research Institute in Little Rock, Vanderbilt University in Nashville, Cincinnati Children’s Hospital, Nationwide Children’s Hospital in Columbus, the Melmed Center in Phoenix, Children’s Hospital of Philadelphia, and the Lurie Center at Massachusetts General Hospital in Lexington.

To support CAMP and the company’s commercialization of this revolutionary diagnostic blood test for autism, NeuroPointDX is launching a crowdfunding campaign, called Providing Children with an Earlier, More Precise Autism Diagnosis, on “We want to raise a minimum of $50,000, with the option to create stretch goals once that amount is reached,” said Donley. “If we publish the data but never bring the test to market, it won’t help one single child or family living with autism.” To learn more or donate, visit

About NeuroPointDX and its parent company, Stemina Biomarker Discovery:

NeuroPointDX is a division of Stemina Biomarker Discovery, which was founded in 2007 and is located in Madison, Wisconsin. Stemina operates its business in two divisions: NeuroPointDX, focused on developing diagnostic tests for neurological disorders; and Stemina, focused on screening chemicals and compounds for their potential to cause birth defects if a woman is exposed during pregnancy.

Visit NeuroPointDX at
Visit Stemina at

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Beth Donley
+1 608-577-9209
Email >

Gina Wentling
Visit website