But Columbia University and biopharmaceutical company Sorrento Therapeutics announced on Wednesday that they intend to bring to market a COVID-19 saliva-based diagnostic test with a 30-minute turnaround—called the COVI-TRACE—after initial clinical studies were first published last month on the non-peer-reviewed preprint server medRxiv.
The team at Columbia University Irving Medical Center and Sorrento say they will, within weeks, scale up those trials, and—if the results are positive—apply for an emergency use authorization from the Food and Drug Administration.
From there, they hope to pursue “rapid, full scale production” of the test to a market in desperate need of test results that come back quickly—and reliably—enough to make coronavirus surveillance possible. What remains to be seen, experts said, was whether this latest potential game changer would deliver the goods amid a sea of hyped vaccine trials, therapies, and testing initiatives that sometimes seem designed to juice stock prices.
The U.S. has tested more citizens per capita than any other country in the world, but many Americans still do not have ready access to COVID-19 tests. The most recent data suggests that actual infections are underreported by a factor of 10 to 13, depending on the state. The reasons for that are plentiful and include the notoriously flawed initial diagnostic test developed by the Centers for Disease Control and Prevention (CDC), the rocky rollout of test kits, controversial initiatives in various regions, and back-and-forths on federal funding to hard-hit states.
It’s difficult to overstate how closely molecular biologists, public health experts, and epidemiologists have been watching the development of testing technology for the past six months. The hope has been that an easy-to-use, easy-to-manufacture, at-home COVID test as affordable and accessible as a pregnancy test could dramatically change the course of the pandemic for the entire world.
Or at least help stave off disaster in the country that has nearly 2 million more coronavirus cases than any other nation on the planet.
To be clear, Columbia’s project is not unique. Last week, researchers at University of Colorado Boulder published their own preprint manuscript—also on medRxiv—announcing that they have developed “a rapid, portable, saliva-based COVID-19 test able to return results in 45 minutes.”
The test, according to a story in the university’s in-house publication, is very similar to Sorrento’s—a patient spits in a test-tube, and a combination of enzymes and a heat source produce a color that indicates whether the test is positive or negative.
Previous research, it should be noted, has pointed to the potential for a reduction in reliability when using saliva compared with the notoriously invasive nasopharyngeal swab usually used in diagnostic testing.
“This technology is about accuracy and speed,” said Dr. Henry Ji, CEO of Sorrento, who claimed that the test’s clinical sensitivity has been measured at 97 percent, with its specificity at 100 percent. Those are two of the indicators most often used to demonstrate a test’s efficacy, though the prototype has so far been used only on a pool of 60 samples.
By speed, Ji explained, he means both the turnaround of the results, and the pace with which the company could potentially scale up manufacturing to produce them on a large scale. The idea is that they may require less complicated equipment, less shipping, and—like the researchers from Colorado claim about their own model—be less likely to hit the wall of backlogs, lab staffing, and supply chain shortages that have plagued the predominant iteration of diagnostic tests.
It’s a simpler and, according to Ji, “more elegant” solution than the current reliance on “real-time reverse transcription polymerase chain reaction”—or rRT-PCR—tests performed in centralized labs. Ji contends his test would eliminate much of the cost, time, and manpower currently used for nearly every COVID-19 diagnosis in the world.
“Imagine you go to an airport, you get tested, you stand outside, and when you test negative they send you a text message with a boarding pass,” said Ji. “If you’re positive, you go back home. Same thing for restaurants, for conventions, and political rallies.”
Ji said the company was aiming to charge about $10 for such a test.
Dr. Adrian Hyzler, the chief medical officer for Healix International, which provides medical information to organizations whose clients travel internationally, was hopeful. “If these tests are cheap and widely available then they really would be the oft-heralded ‘game changer,’” he said.
“The health, social, and economic impacts of lockdown [should] not be underestimated,” added Hyzler.
Even still, experts caution that the FDA’s role is paramount when a truly ineffective test could do just as much damage as a dearth of diagnostic kits.
“We have a saying in the laboratory of ‘garbage in, garbage out,’ which means that a bad test is a bad test, regardless of the number of times you perform [it],” said Nathan A. Ledeboer, medical director of the Clinical Microbiology and Molecular Diagnostics Laboratories at Froedtert and the Medical College of Wisconsin in Milwaukee. To be clear, Ledeboar was speaking generally about the important of test accuracy, not about the COVI-TRACE in particular. “A falsely negative test may give you a sense of security that is not there and may mean that you expose people to the virus.”
The scientists behind the test were confident they’d done their homework.
The past several months of developing the technology and watching its potential unfold has been “exhilarating and energizing and intense,” said Dr. Zev Williams, the chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Irving Medical Center. Williams’ team has spent years developing similar rapid point-of-care technologies to help those with infertility and reproductive medicine. (“Point-of-care” refers to tests that can be completed relatively quickly at or at least close to the site at which they are begun.) When the pandemic struck, they “repurposed” those efforts to see if they could detect the virus, he explained.
Of course, that doesn’t eliminate the potential hurdles the company faces in clearing the upcoming trials and application to the FDA—nor does it mean that Ji could say for certain how many tests would be available within a given timeframe.
Dr. Mark Brunswick, the company’s senior vice president of regulatory affairs, said he expects to submit a report to the FDA by the second week of August, at which point it’s in the agency’s hands. But Ji said there’s a “world of difference” between producing one million tests and producing 100 million.
Still, experts said there was reason for optimism.
“It feels like something real is happening here,” said Dr. Irwin Redlener, founding director of the National Center for Disaster Preparedness and a senior research scholar at Columbia University’s Earth Institute. “This could literally create an environment where we could protect vulnerable people.”
If that sounds profoundly optimistic, Redlener (who is not affiliated with the study) would be the first to admit it—while acknowledging a host of caveats, hurdles, and legitimate reasons for skepticism.
“This is not the first complex promise that we’re about to turn the corner that did not materialize,” Redlener told The Daily Beast. “We should remind ourselves that vaccine promises from Moderna and Pfizer and many other places may not turn out to be effective, like the promise of treatments—hydroxychloroquine for example—or any of the other things that have been proposed.”
“Scaling up of testing does not always fulfill the promise of initial results,” cautioned Redlener.
But while “our hopes have been dashed repeatedly,” he continued, “this does stand out as having much more potential for being realizable than many of the other things we’ve dealt with.”
Linda Garner, an information scientist at CAS, a division of the American Chemical Society, told The Daily Beast on Tuesday that she was “excited by” the test’s initial findings that were published in medRxiv, in particular “the possibility of another genetic test that could be done at a point-of-care setting.”
But while Sorrento’s announcement on Wednesday emphasized the potential for performing “at-home testing,” Garner noted that the requirement for the device to be heated to 63 degrees Celsius—roughly 143 degrees Fahrenheit—“could present a challenge” in that respect.
Garner also noted that a “fully on-site approach, whether at [point-of-care] or possibly at home, has the benefit of reducing the risk of samples being compromised in transport.
“However, it introduces new challenges in getting individuals with a broader range of expertise in a variety of settings to consistently execute the steps outlined to process the tests accurately,” she continued.
Experts surveyed by The Daily Beast roundly cautioned that tests analyzed outside a lab setting may be less reliable. But Williams contended that “what’s best is getting the test done and getting the test done repeatedly.”
It’s a paradigm that has popped up again and again as experts learn about the virus: Best practices at a given moment don’t just evolve. Sometimes they completely reverse based on the nature of the outbreak and the supply of a given tool.