I hope that you and your families are healthy and safe. I wanted to take this opportunity to provide you with an update on our extraordinary progress the past several months, especially under these unique and challenging circumstances.

As most of you know, our company looks quite a bit different today than it did just nine months ago. Within months of launching the world’s first saliva test for autism spectrum disorder, Clarifi ASD, the world was besieged by the COVID-19 pandemic and its economic fallout. Our ability to access healthcare providers and share the scientific and practical utility Clarifi ASD provides to parents and physicians was greatly restricted by social distancing mandates and virus concerns. This, in turn, 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.

But we adapted to market conditions.

In response to the COVID pandemic we immediately reduced our operating costs and developed new lines of business. With years of experience in RNA analysis - and SARS-CoV-2 is an RNA virus - we made the decision to work directly with our academic research partners to develop and commercialize new diagnostic tools to help individuals, organizations and communities navigate the global COVID-19 pandemic.

COVID-19 Testing

Today, we have developed three, integrated COVID-19 solutions to help individuals, communities and policymakers have better confidence in their own health, the health of those around them, and to provide objective data for better decision making.

Our first solution was to develop the Clarifi COVID-19 Test Kit, a non-invasive and easy to administer saliva swab that determines the presence or absence of the SARS-CoV-2 virus. This test kit was co-developed with SUNY Upstate Medical University and received FDA Emergency Use Authorization in September. This accomplishment, and Quadrant’s critical role, was recognized by Governor Cuomo and the Chancellor of the State University of New York (“SUNY”) in an official statement which can be viewed here.

Our second testing solution was developed in response to an overwhelming need to efficiently test university students on campuses across New York State. We again partnered with SUNY Upstate Medical University to conduct pooled surveillance testing of over 200,000 students, faculty and staff at over 60 college campuses across New York State. This pooled surveillance technology represents an accurate and cost-effective solution for schools to track viral transmissions on their campuses. To date, we’ve shipped well over 400,000 test kits to colleges and universities. Moreover, further to a policy mandate by SUNY, we will be involved in testing all resident SUNY students in the next few weeks before they leave for Thanksgiving break!

Finally, Quadrant is part of a consortium that analyzes wastewater for the relative prevalence of the SARS-CoV-2 virus in municipalities and universities across New York State. Sampling wastewater allows for large areas to be efficiently tested for the presence of viral RNA. This data is intended to provide policymakers with advance information about viral transmission rates and the effectiveness of community responses. We recently created Quadrant Viral Testing, a wholly owned subsidiary of Quadrant Biosciences, to develop this business line. Read here about some of our efforts in this area.

Revenue

As a result of our COVID efforts, Quadrant has orders in excess of $17 million since late August! This could not have been accomplished without the dedication and Herculean effort of our staff who have been willing and, as importantly, able to successfully adapt to new roles and responsibilities. We are blessed to have a team at Quadrant that continues to surpass all reasonable expectations in terms of quality and productivity -- I like to say our team members are working and performing at an intellectual level equivalent to a team of three sport athletes. I truly believe the quality of our team is such that none of our goals are outside our reach or capacity, and I cannot tell you how grateful I am to be on this journey with them.

Research Publications and NIH Grant

These COVID-19 projects are very important to our company in the short term -- but we continue to maintain focus on our core mission as an epigenetic diagnostics company. We’re educating parents and clinicians about our flagship product Clarifi ASD™ and continue to develop our research pipeline, including saliva-based tests for Parkinson's disease, and acute concussion injuries. With respect to the latter, on September 15, the NIH awarded us a $2.3 million grant to further our research efforts to develop a saliva RNA test for concussion. Moreover, our collaborative research efforts in the concussion space resulted in the publication of two peer-reviewed papers this Fall: “Diagnosing mild traumatic brain injury using saliva RNA compared to cognitive and balance testing” in the journal Clinical and Translational Medicine, and “Saliva microRNA Biomarkers of Cumulative Concussion” in the International Journal of Molecular Science. We believe the development of a rapid saliva test for concussion would be a game changer and we’re looking forward to working with our research partners to make this happen.

Insurance Reimbursement Update - Clarifi ASD

As you may be aware, Quadrant has been engaged in an effort to provide for insurance reimbursement for our Clarifi ASD product. We believe that insurance reimbursement for early testing of children with autism is needed in order to make our test affordable and available to families everywhere. Late last year we received a unique CPT® PLA code which was a major step toward reimbursement for Clarifi ASD. And just a few weeks ago the Centers for Medicare and Medicaid Services (CMS) released a preliminary payment determination to permit an insurance reimbursement rate of $1,950 for Clarifi ASD. We are very encouraged by this progress and will continue to do everything possible to provide families with affordable access to the Clarifi ASD test.

As you can see, despite the challenges we have faced from the pandemic, Quadrant Biosciences has made some extraordinary progress in the past several months. Thank you again for believing in us and supporting our efforts during these challenging times. We’re happy and thankful to have you by our side as we work to make the world a better place and to provide you with a great return on your investment!

Rich  Uhlig