One issue that has dogged governments and healthcare systems worldwide as they respond to the COVID-19 pandemic is testing—or the lack there of. Not enough tests. Not enough supplies to conduct the tests. Waiting multiple days for results.
A new, rapid, low-cost COVID-19 test has the potential to overcome those problems. The test, also called an assay, was developed by Atila Biosystems, a biotechnology company based in California, and is now being validated by a team of scientists at Dartmouth’s Geisel School of Medicine and Dartmouth-Hitchcock. Based on early results from Dartmouth, the Food and Drug Administration (FDA) granted the Atila assay Emergency Use Authorization.
“This test is unique because it eliminates the need for an extra step to extract RNA from the virus,” said David Leib, PhD, chair of microbiology and immunology at Geisel, whose lab is leading the validation studies. “The test takes about an hour to get results, is highly sensitive, simple, and relatively cheap.”
But is it as accurate as the Centers for Disease Control and Prevention (CDC) test currently in use? Lead scientists Audra Charron, PhD, in Leib’s lab and Joel Lefferts, PhD, in D-H’s Clinical Genomics and Advanced Technology (CGAT) Laboratory have been tackling that question, and the answer so far is “yes.”
“We felt a moral imperative to use our expertise and leverage the ability of our institutions to respond quickly.”David Leib, PhD
Testing the Test
“Audra started validating the Atila kit by performing real-time reactions on clinical specimens obtained from Dartmouth-Hitchcock,” said Leib. (Charron and Leib are married, which has allowed them to work closely in the lab, despite social distancing requirements.)
Joel Lefferts, assistant director of the CGAT Lab, is providing the Leib lab with “blinded” clinical specimens. This means that Charron does not know which samples are from healthy patients, which are from sick patients who tested negative for COVID-19, and which are from patients with confirmed COVID-19.
“We run those specimens through the Atila test. We then de-code the samples with Dr. Lefferts and compare the Atila test with the CDC test to see if the results match,” said Leib. After initial validation of the kit, which had 100% agreement with the CDC test, Charron and Lefferts conducted a thorough study of nasal swab collection conditions and instrumentation from both a standard laboratory and an advanced diagnostics laboratory. The test performed robustly, giving promise to its use in areas over-burdened with patients or laboratories equipped with only basic instrumentation.
The Fast Track
Leib’s lab usually studies herpes simplex virus, but in March they saw an opportunity to help with the COVID-19 pandemic. “We felt a moral imperative to use our expertise and leverage the ability of our institutions to respond quickly,” said Leib. That opportunity presented when a start-up company called CoVelocity contacted Leib, asking for his help in validating the Atila assay. CoVelocity works with governments, hospitals, and biotech companies worldwide to speed the deployment of medical technologies, especially to low-resource countries.
Locally, at Dartmouth-Hitchcock Medical Center, the CGAT Lab has been offering clinical testing for the novel coronavirus since March 18, but expanded testing options are needed. “We have high-throughput testing available that allows us to provide results within 12 to 24 hours but now see the need to also offer more rapid testing options for a variety of more critical situations,” Lefferts explained. “Adding the Atila assay to our test menu could fill that gap.”
Use of the Atila test is currently limited to advanced, specially certified laboratories, such as Dartmouth-Hitchcock’s. But Leib hopes that with the results from his lab and others, the use of the test can be expanded. He sees potential for using it throughout the U.S., as states look for ways to safely re-open their economies—and in countries with fewer resources.
Exactly when this COVID-19 test might be widely available is unknown, but Youxiang Wang, PhD, founder and CEO of Atila Biosystems, said many academic medical centers in the U.S. adopted the Atila iAMP assay (as it is officially known) right after it received Emergency Use Authorization from the FDA. In addition, South Africa, Nigeria, Ghana, Zimbabwe, Holland, and Belgium are among the many countries considering or adopting the test, according to Wang.
“When David’s lab realized the benefit of our Atila’s iAMP assay, they immediately jumped in to evaluate the technology,” said Wang. “David’s lab had the passion and knowledge to run the test. That’s the reason we chose to work with them.”
“This sort of academic-industry partnership is exactly where institutions like Dartmouth excel,” said Leib. “We’ve gotten enormous help from our leadership at Geisel, Dartmouth-Hitchcock, and the provost’s office. They’ve helped us to scale regulatory hurdles to keep us on a fast track.”
And a fast track to rapid, reliable COVID-19 testing is good news for people everywhere.
By Jennifer Durgin