The science explained
A summary of the research and science behind Clarifi
In this video, Dr. Middleton discusses the research and science behind the Clarifi autism test, and how it relies on a new type of molecular analysis that wasn’t even possible until recently.
“The Clarifi experience has taught us that epigenetics and the microbiome are robust indicators of commonly affected processes in autism.”
Dr. Frank Middleton PhD
Associate Professor, Dept. Neuroscience & Physiology, Psychiatry and Behavioral Sciences, and Biochemistry & Molecular Biology, SUNY Upstate Medical University
Combining multiple biomarkers
for more accurate results
A polyomic approach
The interaction of genetic and environmental factors plays a role in autism spectrum disorder. Clarifi measures the activity of genes, including those from the microbiome, by measuring specific RNAs in the saliva. This integrated, polyomic approach, represents the first objective saliva based test for autism based on epigenetics and the microbiome, rather than specific genes or metabolites.
“Our research employs polyomic RNA measures in saliva that link both physiologic and environmental factors implicated in ASD.”
Dr. Steven Hicks MD PhD
Assistant Professor of Academic General Pediatrics at Pennsylvania State College of Medicine
What is epigenetics?
Epigenetics is the study of changes in gene function that do not include changes to the genetic sequence. In very simple terms, genetics is the study of our underlying genes (DNA), while epigenetics is the study of how our genes express themselves.
What is the microbiome?
Each person has 10 to 100 trillion symbiotic microbial cells in their bodies. This collection of “non-human” cells include bacteria, phages, viruses, and yeast and are necessary for the proper functioning of our bodies. This is referred to as the microbiome and is found throughout the body including the gastrointestinal tract and the mouth.
If not specific genes, what is
Clarifi looking for in the saliva?
Clarifi represents a new approach to autism diagnosis. It is based on RNA rather than DNA. Epigenetics rather than genetics.
Using state of the art next-generation sequencing, researchers at SUNY Upstate Medical University, Penn State Hershey, and Quadrant Biosciences identified a broad panel of RNA features useful in diagnosing autism. These include both non-coding human RNAs such as miRNA and piRNA, as well as microbial RNAs associated with specific bacteria in the microbiome.
Key RNA categories
Why do we focus on these non-coding RNAs?
Every gene that encodes a protein comes under the influence of non-coding RNAs, such as miRNA’s, in terms of whether it makes that protein and how much of that protein is made. These RNAs are involved in a wide range of biological processes in the body, making them a robust source of biomarkers for autism.
Our proprietary algorithm uses machine learning to integrate polyomics and patient medical history to provide health care providers an accurate predictor of autism diagnosis.
What do experts in the field think about epigenetics and RNAs?
The science of epigenetics and the microbiome is still relatively young. For example, not long ago scientists did not know miRNA even existed, let alone had any significant function in the body. Clarifi has the benefit of leveraging these new scientific advancements, many by our own research partners.
Differentiating ASD from other developmental delays
Clarifi can accurately differentiate children with autism from those with other developmental delays, not just from neurotypical children. This unique feature can have a profound effect on the way autism is currently diagnosed, and how quickly services are accessed.
Saliva is easy and painless to collect, preferred by families, is stable at room temperatures, and contains high concentrations of miRNAs. Saliva provides a noninvasive way to assess the biology underlying brain function. Clarifi is the first to measure non-coding RNAs in saliva as an autism diagnostic aid.
Laboratory developed test
Clarifi is a Laboratory Developed Test. All Clarifi samples are processed at Admera Health’s CLIA certified and CAP accredited laboratory using Admera’s validated RNA extraction and sequencing protocols, and QB’s proprietary algorithm. All reports are reviewed and approved by Admera Health’s Laboratory Director, and HIPAA confidentiality policies are strictly followed.
Clarifi ASD is now available
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