Clarifi Autism Test: Ask a Scientist

Clarifi Autism Test: Ask a Scientist

Clarifi, an autism saliva test, is about to launch in the United States.

This brand new autism saliva test could impact the way autism spectrum disorder is diagnosed going forward, as it is the first objective, molecular test that can aid the diagnosis of ASD. 

But why is this so important? Up until now, tests for autism spectrum disorder have behavioral-based. For a number of reasons, families are struggling to get a diagnosis for their child at an age when intervention services see the best results. For example, despite the fact that autism can often be accurately diagnosed by age 2, the average age of diagnosis is 53 months (that’s over 4 years old!) 

And despite the growing awareness of ASD, and better understanding of the disorder, the average age of diagnosis for autism hasn’t changed in 15 years

Research has shown that interventions implemented before the age of 4 are actually associated with the most significant advances in cognition, language, and adaptive behavior. This 2017 study concluded “researchers have linked the implementation of early interventions in ASD with improvements in daily living skills and social behavior. Collectively, this evidence suggests that early diagnosis and intervention are imperative in the long-term trajectories and quality of life for children with ASD.”  

As a result, we’ve made it our goal at Quadrant Biosciences to help reduce the average age of diagnosis for autism and help get families on the path to early services. 

So, in preparation for the launch of Clarifi, we wanted to address some of the most frequently asked questions about the science behind our autism saliva test! So, we got the head scientist behind Clarifi, Frank Middleton, to answer some questions.

Who is Dr. Frank Middleton?

Dr. Frank Middleton, PhD is an Associate Professor in the Department of Neuroscience and Physiology, Department of Psychiatry & Behavioral Sciences and the Department of Biochemistry & Molecular Biology at SUNY Upstate Medical University. He is the founder and director of the SUNY Molecular Analysis Core facility, which specializes in next- generation sequencing analysis. He’s published more than 120 peer-reviewed articles and a dozen book chapters in his field.

He, along with his associates, discovered the technology behind the Clarifi autism saliva test and has since published numerous journals and papers about it. If anyone can get you up to speed on the science, it’s Frank. 

Question #1: Is Clarifi A Genetic Test?  Short Answer: No- Clarifi is an epigenetic test!

Frank: The reason it’s not a genetic test is because we’re not assessing or looking for a change in DNA sequence.We are specifically pushing a technology that utilizes epigenetic testing. We believe that the epigenetic level of testing that we are providing represents a final common path. So whether a child may have developed autism spectrum disorder as a result of one particular DNA sequence change, or another one, or potentially some environmental exposure that pushes them toward autism spectrum disorder, we believe there will be a conserved change at the epigenetic level we can measure in the saliva. 
Question #2- How Does Saliva Relate to Autism?

Short Answer- There’s a lot of molecules that reflect brain function in there! 

Frank: It turns out saliva is a treasure trove for molecules that might reflect brain function. The reason that saliva is so well reflective of what is going on in the brain has a lot to do with the simple fact that the brain stem innervates so much of the oropharynx where saliva is made, where you swallow saliva, where you speak, and where you encounter the foods that you’re putting in your mouth all the time. 

It became very apparent that the molecule types we were interested in evaluating were actually present in saliva at levels higher than you find in blood and in other biofluids. What was there in saliva was indeed highly reflective of brain content or brain contributions to the oropharynx. 

Question #3- How Accurate is this Autism Saliva Test?

Short Answer: Clarifi is 82% sensitive, 88% specific, and has a positive predictive value of 91%.

Frank: When evaluating the performance of any molecular diagnostic test, you want to pay very careful attention to overall sensitivity and specificity. One of the statistical measures that combines both of those, would be the overall accuracy of the test or what we would refer to as the area under the curve and a receiver characteristic operating curve analysis. 

The performance of the autism saliva test that we developed yields and ROC area under the curve of greater than 90%.  So the best overall estimate we have of how good the test is, how accurate it can be, is something in the neighborhood of 90% and that is something that performs almost equivalently to the best rapid test that a pediatrician might order in their office for strep infection or influenza testing.  

Want to Learn More? 

Okay, okay- we eventually had to send Frank back to work! But there is a lot to learn about autism spectrum disorder and how our saliva test can play a role in the diagnosis of ASD. So, stay up to date with us! Sign up to receive Clarifi updates on our website, and we’ll let you know about any new papers, more on the science, and how you can get the test. 


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