The Ohio State Wexner Medical Center will conduct the new rapid test with its existing FDA certification permits
Battelle, along with The Ohio State University Wexner Medical Center, has developed a new rapid and sensitive diagnostic test for COVID-19, the disease caused due to the novel coronavirus SARS-CoV-2.
With its existing FDA certification permits, The Ohio State Wexner Medical Center will conduct the new rapid test.
The new rapid and sensitive diagnostic test will help increase test processing in Ohio
The new rapid and sensitive diagnostic test will help increase and enhance test processing in Ohio, as per the existing state clinical guidelines. It will also facilitate faster turnaround time on test results, helping to “flatten the curve.”
Ohio Governor Mike DeWine said: “With this collaboration, we will increase testing right here in Ohio to better help health care professionals and public health officials understand, treat, and prevent the spread of the virus.”
Battelle researchers worked with the firm’s West Jefferson labs in Ohio for the development of a diagnostic assay and complete a validation process. Early results indicate better high sensitivity, said the company.
Since March 14, over 100 Ohio State Wexner Medical Center researchers and clinicians have worked with Battelle researchers to set up a lab for conducting COVID-19 testing.
The researchers from both institutions collected required data to support Ohio State process its first 91 tests for diagnosis using Battelle and Ohio State equipment in a Centers for Medicare & Medicaid Services (CMS)-certified pathology lab at Ohio State.
Currently, Battelle is focusing on the establishment of a second lab in West Jefferson to increase the test processing capacity.
Battelle said that it is also in the process of securing a Clinical Laboratory Improvement Amendment (CLIA) from CMS to start its own clinical testing.
The new rapid and sensitive diagnostic test can offer results within five hours. The system can process up to 200 tests per day and it will be increased to more than 1,000 test swabs per day upon building the required infrastructure.
Battelle president and CEO Lou Von Thaer said: “Battelle has decades of experience in infectious disease research and has worked with virtually all federal health and national security agencies to respond to emerging health threats.”
Separately, Abbott has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its fastest available molecular point-of-care test to detect COVID-19, a novel coronavirus.