NEW YORK – A public-private partnership in Oklahoma is gearing up to begin high-throughput molecular diagnostic testing for COVID-19 using Fluidigm's microfluidic technology, the partners said on Thursday.
The real-time PCR test, developed by the nonprofit Oklahoma Medical Research Foundation and the University of Oklahoma Health Sciences Center, will run on Fluidigm's Biomark HD system and is intended for large-scale testing of patients across the OU Medicine healthcare system and, eventually, the entire state, stakeholders said in a webcast announcing the initiative on Thursday.
Fluidigm's stock jumped about 12 percent on the news in Thursday trading on the Nasdaq.
The new assay, which the partners began developing about a month ago, will be based on standard real-time PCR. However, because it runs on the nanoliter-scale Biomark system, it will have much higher throughput and will lessen some of the reagent supply chain problems that have been plaguing tests around the US.
James Tomasek, vice president for research at the OU Health Sciences Center, said during the webcast that the CLIA lab at OU Medicine will have the ability to run more than 180,000 tests over the next 90 days. "In addition, our researchers are still working on trying to expand the capacity and capability of this test so that we can expand the … number of tests we can do per day," he said.
In addition, the platform may enable greater test accuracy, said Michael Talbert, chief of pathology services for OU Medicine. "Each test will actually be performed five times on the system," he said. "Most other testing platforms do the test once. With five replicates of the test we can make sure the test is performing accurately and precisely."
Mark Lynch, director of microfluidics at Fluidigm, noted during the webcast that the company has reagents "stocked and ready to go," adding that "we've been able to take a very laborious, time-consuming process and do … many [PCR] reactions in parallel while conserving reagents."
The partners have applied for Emergency Use Authorization from the US Food and Drug Administration. In the meantime, although the test is ready for deployment, technicians are still being trained on some of the front end aspects of testing, such as viral RNA extraction and loading the Fluidigm instrument, so testing will probably begin in earnest sometime next week.
"This test is very exciting because it increases our capacity," Judith James, vice president of clinical affairs for OMRF, said during the webcast. "I'm a practicing physician. We've had many patients, especially those who aren't seriously ill but are concerned about symptoms, [interested in testing]. This expanding capacity will allow us to make testing available to patients with mild to moderate disease and first responders."
She added that the partners hope the test will soon allow more of a screening paradigm, "which can be beneficial as we start to think about opening up the state. We need screening at nursing homes and other high-risk places. Expanding our ability to test and do surveillance screening, we increase the chance of being able to get back to the new normal."
Like many omics research tools providers, Fluidigm has leapt to meet the challenge presented by the COVID-19 pandemic and pivoted parts of its business to support diagnostic testing, an area where the company has not traditionally played.
Last month, the company said that it had begun a collaboration with the Icahn School of Medicine at Mount Sinai and a group of other US medical schools to develop a new epigenetic test for early COVID-19 detection using the Biomark HD, with the intent to seek an EUA from the FDA. That initiative is being partially funded through the Epigenetic Characterization and Observation (ECHO) program of the Defense Advanced Research Projects Agency (DARPA) of the US Department of Defense.