A word from our founder and CEO
Richard Uhlig, Founder & CEO
I have no need to tell you that COVID-19 has had a substantial impact on businesses across the globe, and Quadrant has certainly not been immune from that.
However, our team at Quadrant is nothing if not adaptable and resourceful. So, back in March, we made the decision to pivot and allocate some of our resources to directly address this serious pandemic. By leveraging our expertise in RNA analysis, we have been able to be part of three exciting COVID-19 projects.
Please read more about these important efforts below.
The Clarifi COVID-19 Test Kit from SUNY Upstate and Quadrant Biosciences
Quadrant Biosciences was granted an Emergency Use Authorization (EUA) for the detection of novel coronavirus (COVID-19) from the U.S. Food and Drug Administration (FDA).
The Clarifi COVID-19 Test Kit from SUNY Upstate Medical University and Quadrant Biosciences (“Clarifi COVID-19 Test”) leverages Quadrant Biosciences’ established expertise in RNA-based diagnostics. The test uses a non-invasive and easy to administer saliva swab that determines 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.
*On September 22, 2020, The Clarifi COVID-19 Test Kit obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis fo SARS-CoV-2. The Clarifi COVID-19 test Letter of Authorization, along with the authorization Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website.
The Clarifi COVID-19 Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. Clarifi COVID-19 has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This test kit is not a direct to consumer test, nor a testing service for health care providers. This test kit is sold only to clinical laboratories in quantity. There are no single kit sales of this product at this time.
COVID-19 Wastewater Surveillance Project
Our company, in collaboration with Syracuse University, SUNY Upstate Medical University, SUNY College of Environmental Science and Forestry, and global engineering firm Arcadis, is analyzing wastewater across New York State for the COVID-19 virus.
Wastewater surveillance acts as an early warning system for COVID-19 by detecting the presence of viral RNA shed into the sewer systems. Our analysis of wastewater samples will provide local health officials and policymakers with early indications and information regarding the presence and preponderance of COVID-19 infections in these communities.
This allows for large regions to be effectively tested for the presence of the COVID-19 virus, and provides a cost-effective and efficient way to screen residents in towns, cities, states, and universities, even in the absence of individual testing.
Moreover, information from this testing will help municipalities and states to estimate COVID-19 transmission in real-time, provide instant feedback on social distancing and reopening phases, help predict hospitalizations from COVID-19, and provide confidence for locations with zero transmission to resume normal activity.
Pooled sample testing
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 all SUNY students and faculty. To date, over one million tests have been administered.
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 reduces the cost of supplies, staffing, and time required to perform and interpret tests.