Including the world's first epigenetic saliva test for autism

Quadrant Biosciences aims to translate cutting edge medical discoveries into innovative clinical products. Working closely with medical researchers such as SUNY Upstate Medical University and Penn State College of Medicine, we have developed a diagnostic platform, Clarifi™.

Clarifi leverages new discoveries in the field of epigenetics and microbiome research to provide novel diagnostic solutions to many of today's critical health care challenges.

The Clarifi ASD™ Test - A Game-Changer for Autism Diagnostics

Clarifi ASD™, the world's first epigenetic diagnostic aid for autism spectrum disorder, is the first product to emerge from the Clarifi platform.  

What is it?

Clarifi ASD is a saliva test that indicates the probability that a child has autism spectrum disorder.

Who is it for?

Clarifi ASD is being used primarily by pediatricians and family physicians with patients (18 months through 6 years of age) with a positive autism screening test or a clinical suspicion to aid in a formal diagnosis.

Why is it needed?

With 1 in 59 children being diagnosed with autism in the US according to the CDC,  it is one of the most commonly diagnosed developmental disabilities in the country.  Unfortunately, the current diagnostic process involves long wait times, largely the result of a small number of trained clinicians to administer behavioral tests. This, in turn, leads to delays in children receiving crucial intervention services. If autism is identified and treatment is initiated early, the trajectory of a child's life can be positively changed.

How Clarifi ASD Can Make a Difference

For the first time, clinicians have an accurate biological tool to aid in the early diagnosis of autism.  With this simple saliva test, Clarifi ASD can:

     ~  Help start services earlier, when treatment is most effective

     ~  Provide specialists biological data to support their behavioral assessments

     ~  Facilitate cost savings through improving the diagnostic process

When was it launched?

Clarifi ASD was launched commercially in the US in 49 states (excluding New York), in December 2019.

Watch a short video about Clarifi ASD here:

Who we are

Quadrant Biosciences Inc was started in 2015 by Founder and CEO Rich Uhlig, and we have since grown to over 40 employees (and still growing). We are often asked how a small company like ours has achieved so much in such a relatively short period of time. As our VP of Product Management, Kayla Wagner likes to say, “We are small but fierce!”

That ferocity is a shared passion and dedication among each and every member of our Quadrant team to make a difference in our world. We believe we have been entrusted with a technology that will change the trajectory of millions of lives over the coming years, and that we need to be good stewards of that.

Capital Raised to Date

As of January 2020, we have raised over $30 million in previous financing rounds from private investors who have recognized the value in how we intend to change the landscape of diagnostics in the future.

Research Grants Received To Date

We have received numerous grants to support our research efforts.*

Our company has been featured many times in national news and scientific media outlets regarding our research and technology accomplishments in the areas of autism, concussion, and Parkinson's disease.

During the past year, we have engaged in a very aggressive digital marketing campaign to create awareness of the Clarifi brand and the new Clarifi ASD autism test. 

One of the most exciting things that we’ve discovered is that integrating epigenetics and the microbiome can apply to a number of other neurological conditions. As a result, the Clarifi diagnostic platform has applications for many other health issues. Diagnostic solutions for early-stage Parkinson's disease, mTBI/concussion, anorexia, and schizophrenia are currently in development. Several peer-reviewed research papers have already been published on the application of this approach to these worldwide neurological health concerns.

We have numerous peer-reviewed publications supporting our science

To date, there have been 18 peer-reviewed papers published supporting our development of epigenetic biomarkers for autism, mild traumatic brain jury, Parkinson's disease, Anorexia Nervosa and PKAN. These have been published in a variety of scientific journals including JAMA Pediatrics, Frontiers in Genetics, Journal of Neurotrauma, Journal of Oral Microbiology, Journal of Experimental Neuroscience, and Autism Research.

Research Partnerships

Scientific breakthroughs are seldom achieved alone, but rather the product of researchers working together toward a common goal. Our story is no different. We are honored to partner with a number of outstanding research universities and organizations to help further the understanding of epigenetics.

International Research Partnerships

We also actively partnered with several international research organizations:

European Autism Interventions, A Multicentre Study for Developing New Medications (EU-AIMS) - first Europe-wide collaboration between organizations with the goal of identifying markers of autism that would help in earlier and more accurate diagnosis, prognosis, and the development with new therapies

Comprehensive Care Center for Disability (CAID) - centers in Santiago, San Juan, Higuey and Santo Domingo, the Dominican Republic dedicated to the evaluation, diagnosis and rehabilitation of children from zero to ten years with Autism Spectrum Disorder.

Our Clinical Advisory Board 

Our clinical advisory board comprises some of the leading autism and epigenetic researchers and clinicians. It is our privilege to work alongside these luminaries in the field to help families and children with autism.

What parents are saying: 

What health care providers are saying: 

~  “A test that can separate children who have screened positive into high likelihood of autism or low likelihood of autism could help streamline waitlists and permit earlier diagnosis and enrollment in autism treatment.” -- Daniel Coury MD, Professor of Pediatrics and Psychiatry in the College of Medicine at The Ohio State University

~  "If most children aren’t being diagnosed until after age four, we’re losing months if not years of intervention that can deliver benefits throughout their lives.”  -- Thomas Frazier, PhD, Chief Science Officer, Autism Speaks

~  "As a pediatrician with special interest in autism spectrum disorder, I routinely conduct autism evaluations and have used Clarifi ASD as part of my battery of assessments. Having a biological test that indicates a child’s probability of an autism diagnosis is invaluable. For the first time in my career, I have biological data to support my clinical impressions and reduce clinical uncertainty. Clarifi ASD really made parents feel confident in the outcome of my evaluation and motivated them to access services immediately, which is truly the most important goal.” -- Mark Barros MD, THINK Neurology for Kids

~  “In too many cases children may not receive a diagnosis until they are 5 years old. Early diagnosis is critical for children with autism, and primary care providers play an important role in that initial process.” -- Kristin Sohl MD, Associate Professor, Clinical Child Health Vice Chair for Quality Improvement, Child Health Department Advocacy Director, Child Health Department Director, ECHO Autism

Here’s how Clarifi testing looks from the parent perspective:

And how clinicians use the Clarifi ASD test:

What is the Breakthrough Science Behind Clarifi ASD?

The interaction of genetic and environmental factors plays a significant role in autism spectrum disorder. Using state of the art next-generation sequencing, a broad panel of epigenetic molecules were discovered to be 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. 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.

Dr. Frank Middleton answers basic questions about the science behind the Clarifi ASD test.

Discoveries made possible using the power of machine learning

Using a machine learning algorithm, we were able to test about 20,000 possible components in the saliva before arriving at the best performing combination for the test. Without machine learning, this would have taken thousands of years to work through.

The proprietary algorithm behind the Clarifi diagnostic platform uses machine learning to integrate 1) the human non-coding RNA, 2) the non-human bacteria from the microbiome, and 3) patient medical history to provide health care providers an accurate predictor of autism diagnosis.

Want to learn more?

For more information about the company, download the investor deck and visit Quadrant Biosciences  www.quadrantbiosciences.com; for more information about the Clarifi ASD visit www.clarifiasd.com.

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