A blood test to identify several foods or vitamin supplements that children with autism disorder cannot process in the normal way could be available as soon as a year from now, a Madison company says.
NeuroPointDX, a division of Stemina Biomarker Discovery, has identified a group of children with autism who have elevated levels of a particular type of fatty acid.
NeuroPoint is conducting a study to see if reducing consumption of foods such as fatty fish or fish oil supplements will diminish autism symptoms in those children.
If the results are positive, the biomarker will become the first part of a panel that will test children for as many as six or more biomarkers — differences in body chemistry — that Stemina has identified in earlier studies, said Stemina CEO and co-founder Elizabeth Donley.
NeuroPoint’s study, called CAMP, or Children’s Autism Metabolome Project, will involve 1,500 children at eight locations around the U.S. The effort started in September 2015 and is expected to take until early 2018 to complete. More than 570 youngsters, between 18 months and 4 years old, have been tested so far, Donley said.
“Our goal is to validate those six (biomarkers) in the clinical studies and then to continue to add to those by studying the patients for additional subtypes,” she said.
Donley said research has shown that foods or ingredients that children consume can have an impact on autism symptoms but it has been hard to pinpoint the specific triggers. “It’s fairly well known that certain people respond well to a modified diet. Eliminating gluten works for some kids — but their diet is often very restricted,” she said.
She said earlier studies conducted in 2012 through 2015, involving a total of about 500 children, helped Stemina identify the six biomarkers. They examined banked blood samples from the MIND Institute at the University of California-Davis and from Arkansas Children’s Hospital in Little Rock.
While one fatty acid has been disclosed, Donley is not yet publicly naming the other five discoveries.
The ultimate goal, she said, is to develop a test that will diagnose children with autism at an earlier age. Right now, Donley said, children are, on average, 4½ years old when they are diagnosed, according to the Centers for Disease Control.
Along with the earlier identification, Donley is hoping the test will show if changes in diet will modify autistic behaviors. That could result in treatment that is “pretty innocuous,” she said.
“Our current goal is to have a test on the market around the first of the year. Some of that depends on the pace of enrollment (in the CAMP study) and success in our fundraising,” said Donley.
Stemina has hired a Boston investment firm to help the company raise up to $25 million. The money will be used to build laboratories — Stemina’s offices are at 504 W. Rosa Road, in University Research Park — and to hire staff.
The company, which began operating in 2007, has 15 employees. Donley said she hopes to hit nearly 80 employees by the end of 2018, including clinicians who will process the blood samples and catalog results; sales staff; quality-control specialists; and metabolic counselors who can interpret the test results.
For Donley, a patent attorney who served as general counsel and director of business development for the Wisconsin Alumni Research Foundation for more than eight years, the search for answers is not just scientific; it is also personal. Her son, Jack, now 20, is autistic.
“For him, a modified diet has made a difference in his attention and concentration, but we don’t know which things that we eliminated helped him,” she said.
Stemina won permission from the state of Wisconsin in 2016 for use of its test for fatty acid without requiring federal approval. But the company is holding off on a release until it has a broader panel of biomarkers for testing and approval from more states, Donley said.
So far, Stemina has raised $10.8 million from investors and the Nancy Lurie Marks Family Foundation and $7.5 million through grants.
Another division of the company is using stem cell technology to test drugs, chemicals, cosmetics and household products for the potential to cause birth defects.