As the old proverb goes, if at first you don't succeed, try, try again. Chembio Diagnostics is putting those words into action as the company pursues an emergency use authorization (EUA) for a new COVID-19 antibody testing system. Chembio says the new test, DPP SARS-CoV-2 IgM/IgG, provides results in 15 minutes from finger stick, venous whole blood, plasma, or serum samples.
The Medford, NY-based company was one of the first firms to get an EUA for an antibody test during the pandemic, and also was one of the first to have its EUA revoked by FDA due to performance concerns regarding the accuracy of the test. During the company's earnings call last month, Rick Eberly, Chembio's president and CEO, said the revocation had a significant negative impact on the company's product revenues and gross product margins in the second quarter and triggered a recall of unused tests from U.S. customers.
“We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system,” Eberly said in a statement this issued week. “Submission of the EUA application for this test system has been the top priority for our organization because we understand there is a large need in the market for additional rapid tests – especially ones that offer the ability to decentralize testing locations. We are excited to offer a solution to patients and clinicians across the healthcare system that addresses these needs.”
Chembio says the new DPP SARS-CoV-2 IgM/IgG test system detects antibodies to the spike receptor-binding domain in the blood that the body produces in response to a COVID-19 infection. The test uses Chembio’s battery-powered Micro Reader 1 or Micro Reader 2 analyzers that are produced by Chembio Germany. According to the company, the DPP platform’s ability to "provide objective, numerical results can aid clinicians in avoiding the human interpretation errors associated with visual readings of traditional lateral flow tests."
COVID-19 antibody testing may assist clinicians in determining a patient's current or past exposure to the virus. The results and data from the test can contribute to improved clinical outcomes through the management of individual patients, as a population surveillance tool, and to potentially evaluate immune responses to anticipated vaccine administration, Chembio noted.
"We stand behind the real-world clinical data and performance of our original COVID-19 system," Eberly said during the Aug. 6 earnings call, according to Seeking Alpha transcripts. "...From the offset of the pandemic, we recognized our proprietary DPP technology could provide value across several COVID-19 related testing applications. The DPP technology in combination with our micro readers provides specific benefits that we believe make it well suited to point-of-care testing. The system is portable, provides accurate results in 15 minutes from finger stick blood or other samples, and is designed to detect multiple biomarkers simultaneously and discreetly."
Eberly went on to point out that the testing workflow is easy to use and scalable. He said clinicians can run multiple tests at the same time because test cartridges are only required to be inserted in the micro reader for 15 seconds to obtain results following the 15-minute test incubation period.
Also during the Aug. 6 earnings call, Eberly laid out the company's plans for leveraging Chembio's technology to develop a portfolio of COVID-19 tests. At that time, he said, Chembio was developing a revised DPP CPVOD-19 IgM/IgG system for antibody detection, and the DPP COVID-19 antigen system for viral protein detection. Further down the pipeline is a revised DPP COVID-19 IgM/IgG systems, a serology test for the detection of two types of COVID-19 antibodies.
Eberly said FDA identified new performance criteria in June that COVID-19 antibody testing systems must now meet to get an EUA.
"These defined standards have provided us with clarity and direction for our development objectives," he said. "The scientific and clinical knowledge base, along with our understanding of the virus and how it interacts with our technology, have both expanded significantly since our initial EUA was received. We are optimistic that with the clear definition of these requirements, combined with the expertise of our scientists and the flexibility of our platform, we can complete a revised system in a short period of time."