As COVID-19 began to sweep across the country in March, the Chief Executive Officer of one of Knoxville’s life science companies shared with us the team’s initial thoughts about how it might help in the response.
“We are exploring ways that we can use our facility (which is biosafety level 2) and our cancer blood testing equipment and re-purpose the lab to help during this pandemic response,” said EDP Biotech Corporation’s Eric Mayer in this teknovation.biz article. “While it is not a pivot for the business, we understand that these difficult times require immediate and creative solutions, and EDP Biotech has offered our help in any way needed at the local and state level.”
Fast forward to this week, and the company, located on Baum Drive, is now launching the IgG multiplex test manufactured by Quansys Biosciences. It is described by the Utah-based company as “the first planar-based multiplex assay to allow simultaneous detection of human antibodies to the SARS-CoV-2 S1 protein, SARS-CoV-2 S2 protein, a negative control (Sheep Fc), and a positive control (anti-human IgG).”
Now that the U.S. Food and Drug Administration has cleared the use of the test, EDP Biotech is able to be a testing resource for local employers, thanks to the local company’s designation as a CLIA-certified lab. CLIA stands for the Clinical Laboratory Improvement Amendments of 1988 that established federal regulatory standards applicable to all clinical laboratory testing performed on humans in the U.S., except in clinical trials and basic research.
“We are excited to get started with COVID testing this week,” Mayer said. “We have capacity for 600 per day right now with current personnel and equipment. Our goal is to ramp up beyond 1,000 a day.”
The first client was an Oak Ridge company on Monday and others are in the pipeline. Employers, community organizations, and schools that are interested in bulk testing can contact EDP Biotech directly at firstname.lastname@example.org. An “at home” blood collection device is still pending Emergency Use Authorization, so all testing and phlebotomy for now will be performed by appointment at EDP Biotech’s CLIA lab. Interested individuals can sign-up online at www.edpbiotech.com/covid19.
“Accurate antibody testing will help individuals and health departments understand the length of potential immunity after infection, and the prevalence of asymptomatic people who have antibodies but were never swab tested,” Mayer said. “We must have a better understanding of the virus’ spread in Knoxville and how long antibodies stay in people’s systems to make the most informed policy decisions moving forward.”
As far as the partnership with Quansys Biosciences, Mayer said that “EDP Biotech has evaluated many different tests to find and provide the most accurate testing option locally.” That is important to any business, but particularly one founded by a well-known local entrepreneur.
“As Knoxville employers open their businesses and students plan to go back to school, we are a local business providing a new testing resource during this unprecedented pandemic, and the importance of testing is clearly highlighted by our recent spike in local cases,” Mayer said. “We will be working with several employers in the region testing all of their employees to help give them a baseline to make initial ‘come back to work’ policies and decisions.”
Concerning the company’s focus on early detection of colorectal cancer and the commercial rollout of its ColoPlex™, product, Mayer said, “The results of our large clinical research study were recently presented at the NIH/NCI’s Early Detection Research Network committee meeting on June 30. Based on recent progress, we can continue strengthening our relationship with a diagnostics strategic partner throughout July and utilize resources offered by the CO.LAB ‘HealthTech Accelerator’ program to better engage our ColoPlex™ early adopters.”