Ipsum Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has issued the Emergency Use Authorization (EUA) for their high capacity COVID-19 RT-PCR EUA Test method for the detection of the novel coronavirus (COVID-19). Ipsum will immediately share their test methodology with small labs across the U.S. increasing the testing capacity to healthcare providers and their patients. Instead of it taking days, test results are available within 24 hours.
You cough, and you wonder. You run a fever, and you worry. Then you have difficulty breathing, and you think, “Where can I be tested?” Across the country, this is the new normal. Well, in Atlanta, Georgia, one of the best kept secrets is Ipsum Diagnostics, an independent lab that is using its expertise to pitch in and help fight the Coronavirus pandemic.
Ipsum is a national reference laboratory specializing in molecular pathogen detection. Ipsum provides a novel solution for testing 5,000 COVID-19 samples per day on one instrument. And Lauren Bricks, Ipsum’s Co-Owner and COO and team, quickly recognized that Ipsum could adapt and share their test methodology freely with the existing infrastructure of small, independent labs across the US.
Ipsum validated an assay for SARS-CoV-2 on a high throughput PCR instrument. There are roughly 100 labs throughout the country using the Quant Studio 12K Flex that can accommodate a 384 well plate versus the current test of only a 98 well plate. The infrastructure is already in place and will increase testing capacity to four times what is available now. Deploying Ipsum’s EUA will facilitate implementation of COVID-19 testing in these laboratories.
“We see this as a real-world solution to the lack of national testing. This will enable healthcare providers to collect patient specimens and send them to laboratories within their communities that are using Ipsum’s COVID-19 test method.”, Bricks said.
This method will fill an urgent national need. “Increased capacity for COVID-19 (Coronavirus) testing is the only solution,” says Bricks. “Our laboratory is offering rapid, reliable diagnostic testing results within 24 hours to test patients for COVID-19. Use of this method has the potential to change the climate of COVID-19 testing. Overwhelming testing backlogs will be a thing of the past.”
We are working directly with a lab in West Virginia, a state that has no testing, to quickly implement this method. We are providing a turnkey solution which extends to training testing personnel at our laboratory. They will return to their laboratory in West Virginia fully ready to implement our workflow in their facility.
Historically, private independent laboratories do not share proprietary methods. This is an unprecedented response to an unprecedented situation.
“Ipsum’s Laboratory Director and Molecular Diagnostics Director, Dr. Henry Skelton and Dr. Steven Marlowe worked closely with our talented team to bring this to completion. We are currently performing testing and are committed to helping other laboratory’s do the same.” Bricks added
Bricks closed by emphasizing, “The pandemic is global in scope, yet it is very personal. The virus is threatening the ones we hold dear, our families and friends and it has a direct impact on our communities. This is the moment and the time when we can make a difference.”