detect a subset of kids with autism.”
Donley says she and others study leaders plan to submit additional papers for publication in scientific journals with findings from the CAMP study. They’re aiming to have a second submission by the end of December, she says.
Meanwhile, Donley says that NeuroPointDX, a business division of Stemina focused on detecting and enabling better treatment of neurological disorders based on a patient’s metabolism, is likely to begin shipping the test used in the CAMP study to sites across the U.S. later this year. Stemina is not required to complete the study before it can begin shipping the test, she says.
“We are delivering it through a beta program right now to some early adopters, including our clinical sites and a few other places throughout the country, for free for up to 50 patients,” Donley says. Tests are shipped to laboratories, not directly to consumers, she says.
Stemina was not required to receive FDA clearance for its test, Donley says. Instead, clinical laboratories regulated by agencies in their states will be responsible for administering tests, she says. Stemina currently has approvals for the test in all but five U.S. states. Donley says she expects the test to be approved in every state except New York by year-end. (It can be “very difficult” to get a registration for a new clinical lab test approved in New York, she says.)
Stemina plans to introduce the test in Canada and some European countries in the next couple years, Donley says, and will likely add one or more partners to help in areas like international shipping and receiving.
