Saliva Test For Autism Hits Market
SYRACUSE, N.Y. — A saliva test designed to quickly diagnose autism in toddlers has hit the market after seven years of research at SUNY Upstate Medical University and Penn State.
The researchers hope the test will help doctors detect autism faster and get children help sooner, when it can be most effective.
The test was released in December by Quadrant Biosciences Inc., a company located on Upstate’s Syracuse campus. The company partners with Upstate through the state’s StartUp NY program which gives new and expanding businesses tax breaks and access to university researchers.
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“Saliva is a treasure trove for molecules that might reflect brain function,” said Frank Middleton, an Upstate associate professor and co-lead investigator on the research behind the test.
The prevalence of autism is soaring. An estimated 1 in 59 U.S. children are diagnosed with the disorder, up from 1 in 125 in 2008. Autism is a developmental disability that affects learning, communication and interaction with others.
The test, called Clarifi ASD, is one of the first medical tests to diagnose autism. A Wisconsin company introduced a blood test in 2018 to identify autism.
Health care professionals diagnose autism by observing a child’s behavior. Families often face long wait times for autism evaluations. While it’s possible to diagnose kids as young as 18 months, the average age of diagnosis in the U.S. exceeds 4 years old.
“Our overarching mission is to move the average age of diagnosis from over four years of age to the second year of life, and get these children into behavioral therapies earlier,” said Richard Uhlig, founder and CEO of Quadrant.
The test has been approved by the federal Centers for Medicare and Medicaid Services which regulates clinical laboratories. It’s available in all states except New York, which requires state Health Department approval. The company expects to get state approval this year.
The test costs $989 and is not yet covered by health insurance. The National Institutes of Health is working with Quadrant to get the test covered by Medicaid and private insurers. The NIH provided a $2 million grant to help fund research behind the test.
The test is available by prescription only and must be ordered and administered by a health care provider. Saliva is collected by swabbing a child’s mouth. Test results are available in three to six weeks.
Researchers from Upstate and Penn State identified certain short strands of ribonucleic acid found in saliva that differentiates children with autism from kids who are neurotypical or have non-autistic developmental delays. A published peer-reviewed research study involving 450 children ages 18 months to 6 years found the test was 85 percent accurate in identifying kids with autism.
The test is supposed to be used in conjunction with developmental and behavioral assessments. The company said a test that shows a high probability of autism may give clinicians more confidence to make the diagnosis and start early intervention services, instead of putting the child on a long waiting list.
Quadrant also is conducting research to develop saliva tests to diagnose concussions and Parkinson’s disease.
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