From Epigenetic Diagnostics to Comprehensive COVID-19 Testing -- How Did We Get Here?

Leaders in the Development of Epigenetic Diagnostic Tools

Quadrant Biosciences is a life science company working with universities across the US to develop and commercialize epigenetic diagnostic solutions for autism spectrum disorder, Parkinson’s disease, and concussions. Working closely with medical researchers such as SUNY Upstate Medical University and Penn State College of Medicine, we have developed a novel, saliva-based diagnostic platform called Clarifi™.

In December 2019 we launched Clarifi ASD™, the world's first saliva test for autism spectrum disorder. The test, intended for children 18 months through six years of age, provides a probability of an autism diagnosis based on epigenetic markers in the saliva.

Then the COVID-19 Pandemic happened

Not long after we began to introduce Clarifi ASD to pediatric health care providers, the world was besieged by the COVID-19 pandemic. Our ability to access healthcare providers and share the scientific and practical utility Clarifi ASD provides to parents and physicians has been greatly restricted by social distancing mandates and virus concerns which, in turn, has limited our sales team’s ability to affect sales and increased commercial demand for Clarifi ASD. As a result, our sales of the Clarifi ASD test have been below expectations.

So, we adapted!

In response to the COVID pandemic we immediately reduced our operating costs and, given our existing experience with RNA analysis - and the fact that COVID-19 is an RNA virus - we made the decision to pivot and work with our university partners to develop diagnostic tools for COVID-19. As a result, today we are involved in three significant, complementary COVID-19 projects to aid in the detection of COVID-19 in individuals and communities across the U.S.

Three Levels of Testing: A comprehensive Approach to Assessing COVID-19

1. 1. Individual Testing - Clarifi COVID-19 Test Kit

Partnering with Upstate Medical University, we first embarked on the development of an individual test for COVID-19. This proved to be a natural extension of our work with Clarifi ASD™ which used a similar saliva collection methodology. Coincidentally, two features of our Clarifi approach - using a simple saliva swab and employing an RNA stabilizing solution - happened to address two key challenges experienced by many of the early COVID-19 tests: patient discomfort from nasal swabbing, and RNA degradation giving rise to false-negative test results.

The Clarifi COVID-19 Test Kit contains a non-invasive and easy to administer swab that is used to collect saliva, which is analyzed to determine the presence or absence of SARS-CoV-2 viral RNA. The Clarifi COVID-19 Test Kit contains the saliva collection swab and the reagents needed to run the analysis and will be immediately available for use by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics, and hospitals.

The Clarifi COVID-19 Test Kit was initially submitted to the FDA on [May 22, 2020] for Emergency Use Authorization (“EUA”). We have been in active dialogue with the FDA regarding our EUA request and we hope to receive approval in the coming weeks. Please note, however, that there are no guarantees that the FDA will provide this authorization for commercial use, and if we do not receive EUA approval it would materially impair our company’s business and prospects.

2. Community/Municipal Screening: Wastewater Surveillance

This project, funded by New York State, involves our collaboration with SUNY ESF, Upstate Medical University, Syracuse University, and global civil engineering firm Arcadis, to collect and analyze wastewater from the county and municipal sewer systems for the presence of the COVID-19 virus. Our analysis of wastewater samples provides local health officials and policymakers with early indications and information regarding the presence and preponderance of COVID-19 infections in these communities.

“This can be a real game-changer in the detection and monitoring of COVID-19,” said Quadrant Biosciences CEO Richard Uhlig. “Information from this testing will allow municipalities to estimate COVID-19 transmission in real time, provide instant feedback on social distancing and reopening phases, help predict hospitalizations and provide confidence for locations with zero transmission to resume normal activity.”

Because this allows for large regions to be effectively tested for the presence of the COVID-19 virus, it provides a cost-effective and efficient way to screen residents in towns, cities, states, and universities, even in the absence of individual testing.

3. Group/College Testing: Pooled Testing

Finally, in response to an overwhelming need to efficiently test university students prior to attending classes, we have partnered with the Upstate Medical University to conduct pooled testing of over 150,000 students preparing to begin the fall semester at SUNY schools.

Each of these pooled tests for COVID-19 involves a single test of saliva samples collected from a group of 12 students. A negative test result means that all 12 students are presumed to be coronavirus-free. A positive test for the pool would mean every student in that group would need to be individually tested. Performing single tests of groups of students greatly reduce the cost of supplies, staffing, and time required to perform and interpret tests.

Disclaimer: Despite the fact that we have the expertise, capability and customer demand for these COVID-19 tests, the supplies needed to perform quantitative PCR are becoming increasingly difficult to obtain. This, and supply chain disruptions generally throughout the industry, could impair our ability to successfully commercialize one or all of these tests

But, we are still very much an Epigenetics Diagnostic Company!

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

We continue to maintain a focus on our core mission to develop epigenetic diagnostic tools, such as Clarifi ASD™, the world's first saliva test for autism spectrum disorder.

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 54 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 critical 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. Our team has a shared passion in being a part of positive changes in healthcare.

“As a company, we are committed to looking outside ourselves, and deploying our resources to assist other organizations and research efforts dedicated to improving the lives of people with autism and their families.”Richard Uhlig, Founder and CEO, Quadrant Biosciences

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.*

(*The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.)

Quadrant Biosciences in the Media

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.

Clarifi ASD is just the Beginning! Future products in the works.

One of the most exciting things that we’ve discovered is that our Clarifi epigenetic 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 Pantothenate kinase-associated neurodegeneration disease (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

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.

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.