What is Clarifi?

What is Clarifi?

What is Clarifi? Clarifi is a biological test for autism.

While a lot of progress has been made in the past few years in this field of research, we are especially excited to debut this test because it uses saliva. As opposed to other biological tests being developed, which use blood, the Clarifi autism saliva test is painless and simple to administer. This can be an essential factor in turning a stressful appointment at the doctors, into a more comfortable one. Not to mention, it holds its ground in the scientific side of things. Our head scientist, Frank Middleton, PhD, explains it best.

“We found that saliva is a treasure trove for molecules that might reflect brain function. We felt that was a key component for the development of a test that’s going to essentially evaluate a change in brain function,” Middleton explains.

What’s Going on in My Saliva?

The reason saliva is so well characteristic or reflective of what’s going on in the brain has a lot to do with location.

The brain stem innervates much of the oropharynx- which is where saliva is made, where you swallow saliva, where you speak, and where you encounter the foods you’re putting in your mouth all the time.

Dr. Middleton explains this is a perfect lead for autism diagnosis, because there is already “ample scientific data showing there are changes in some of those functions of children with autism to begin with.”

“As we started to do the studies, it became very apparent that the molecule types we were interested in evaluating were actually present in saliva at levels that were higher than you find in blood, in other biofluids and in other tissues. And what was in saliva was highly reflective of brain content, or brain contributions to the oraphynx,” Middleton said.

Aren’t there some variables, though?

Yes, of course! Some variables could be oral hygiene, or diet, for example. But, in regards to the variability of these factors, our machine learning algorithm has taken it all into account.

The Clarifi algorithm adjusts for the time of day the autism saliva test was given, dietary restrictions, and amount of time since the child last ate and brushed their teeth. The machine learning algorithm has proved capable of measuring and obtaining the same values in a repeated fashion successfully.

For a deeper dive on the science behind our autism saliva test as a whole, read our validation paper, published in Frontiers in Genetics.

The Current Landscape:

Currently, families throughout the country are waiting months to years while trying to get an official ASD diagnosis for their child. While children can be accurately screened for autism spectrum disorder at 18 months old, the national average age of diagnosis is still four years (and four months) old, despite statistics that say 85% of parents or caregivers of children diagnosed with ASD had concerns about their development by the time they were three years old.

Not only are these children losing valuable time for intervention services, but new research claims a later diagnosis is even costing families thousands of dollars more in the long run. So what is causing the traffic jam on this diagnostic highway? For a couple reasons.

1. Children are getting the wrong diagnosis first.

Autism is truly a spectrum. Symptoms and signs present themselves differently in each child. On initial evaluation, children can be misdiagnosed with ADHD, ADD, sensory processing issues, or a myriad of things that aren’t actually what’s going on.

2. A shortage of developmental and behavioral pediatrics specialists

Right now, the most popular way to get an official autism spectrum disorder diagnosis is through a developmental and behavioral specialist. These specialists are so important to the process, as they have the tools and skills to assess a child and figure out what’s going on developmentally that a regular pediatrician may not have.

The problem is, our country is facing a shortage of these clinicians. Caroyln Bridgemogan, co-director of the Autism Spectrum Center at Boston Children’s Hospital, went as far as to say “there is a crisis right now as there are many children in need and not enough specialists to care for them.”

Clarifi in Practice:

This is where the Clarifi saliva test comes in.

The Clarifi autism saliva test has the ability to tell if a child has autism spectrum disorder, a developmental delay that’s not ASD, or if a child is developing neurotypical after all.

Clarifi is to be used in conjunction with other screens and diagnostic tools. It’s not throwing out the book that we already know and love, it’s just adding an objective tool that can help pediatricians diagnose some cases, and give specialists more time with more complex cases.

Since there is question over the effectiveness of the M-CHAT, with the American Academy of Pediatrics even questioning if it’s time for something new, and we know that an early diagnosis is the key to children with autism spectrum disorder leading more successful lives, isn’t it time we introduce a new tool?

As a result, Clarifi can be that perfect additional screening tool to help smoothen and shorten the diagnostic process.

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