A Madison company says it will make its blood test for autism in young children available as soon as this spring, and it is staging a crowdfunding campaign to help pay for the launch.
NeuroPointDX, a division of Stemina Biomarker Discovery, said its study of 1,100 children, ages 18 months to 4 years old, has validated 12 biomarkers linked to autism spectrum disorder that were identified in the company’s previous studies.
The 12 biomarkers examined in the metabolic study show differences in the way some children process certain amino acids, and they account for about 30 percent of children with autism, said Elizabeth Donley, CEO of NeuroPointDX.
“It will allow us to diagnose kids as young as 18 months, and provide information that may give insight into the best course of action for children,” Donley said.
She said she plans to submit the conclusions of the Children’s Autism Metabolome Project — a two-year clinical study the company conducted at eight sites — for publication in a scientific journal.
“It is not an exaggeration to say that NeuroPointDX will revolutionize diagnosis and precision medicine,” Donley said. “By identifying imbalances in the patient’s metabolism, we can diagnose neurological disorders and identify targeted treatments.”
The treatments could involve changing the patient’s diet, adding dietary supplements, or developing new drugs, she said.
NeuroPointDX does not need to get approval from the U.S. Food and Drug Administration, Donley said. Instead, it can be delivered through the Clinical Laboratory Improvement Amendment, which is a state-by-state regulated process. Stemina has received its registration from the state of Wisconsin, which allows the company to deliver the high-complexity diagnostic test from its lab in Madison.
Donley admits that crowdfunding for a neurological test, on experiment.com, is an unusual route to take.
“We decided to start with (asking for) $50,000 and see if we can draw some significant interest,” she said. “It’s another avenue to get people paying attention to what we’re doing, to gauge grassroots interest.”
It’s only a start to what NeuroPointDX will need for large-scale testing, though. So Donley will seek funding through the usual investor channels, as well. “We need to raise a minimum of $10 million to really commercialize this effectively,” she said.
Stemina was founded in 2007. Its other division screens chemicals and compounds for their potential to cause birth defects if a woman is exposed during pregnancy. Stemina and NeuroPointDX have 13 employees.