A new novel coronavirus test developed by the Georgia Esoteric and Molecular (GEM) Laboratory at the Georgia Department of Pathology promises diagnosis turnaround capabilities of just two hours.
At this time, the test is meant for patients of the Augusta University Health System. That said, Dr. Ravindra Kolhe, director of the GEM Lab and chief of the Section of Molecular and Genetic Pathology, noted that the lab could potentially test samples from outside the immediate area when requested. Given that the test represents a major gain over the days-long backlog much of the country is still facing for tests, such requests could prove alluring. While those details are still being hammered out, the main priority for the new test will be diagnosing locals.
“We want patients and physicians in our community to have timely access to information that will ultimately benefit us all by helping limit spread of the virus,” Kolhe said. “More rapid identification of individuals who are infected will help ensure they get help as needed and that the risk of exposure to others is significantly reduced. We completed our COVID-19 assay validation on Sunday and immediately submitted the documentation to the FDA for their approval. This was a nonstop 90-hour effort by the phenomenal team in the GEM lab to develop this test, but we all felt a commitment to our community to make this test available here.”
Kolhe did not shy from the test’s implications. Given that identifying and quarantining infected individuals within hours could have a significant impact on infection spread, he said the lab was now running tests around the clock.
Approval from the Food and Drug Administration is still pending. However, under new guidance, its approval is no longer required for COVID-19 testing, so long as it is conducted in a Centers for Medicare and Medicaid Services-certified lab. The GEM is currently running 72 tests in 24 hours but hopes to expand to 500 in the days ahead.
The test is based on modified testing recommendations from the Centers for Disease Control and Prevention. It tracks two genetic markers unique to the novel coronavirus, though the GEM team is currently looking for additional markers. “Everybody is looking at these targets, and everybody has a different way of looking at them,” Kolhe says. “The biggest game-changer in this is the turnaround time for patients because we are able to provide the test locally.”