In other words, it would likely be a big deal, if it works.
3M announced Tuesday its “antigen” testing effort received “phase 1” approval from a recently created federal effort to accelerate the deployment of COVID-19 testing technology. But 3M still must pass “phase 2” and receive regulatory approval for the test.
“The holy grail of this would be something akin to a home pregnancy test,” said John Banovetz, 3M’s chief technology officer.
That’s not to say 3M’s test would be sold at retailers like a pregnancy test. But people could quickly get COVID test results “at the point of care,” Banovetz said.
3M would use paper as a testing medium, which would change its physical state if the virus were present.
The most common way to detect COVID-19 is through a polymerase chain-reaction (PCR) test. Test samples, usually from nasal swabbing, must be sent to a government-accredited lab, where technicians look for the virus’ genetic material.
Hospitalized patients can get their PCR tests turned around in two to four hours, but even hospitals have limitations, said Sophia Yohe, an associate professor at the U’s Medical School and director of its molecular diagnostics laboratory.
Outside of hospitals, the wait is considerably longer. Four days is “pretty reasonable,” Yohe said, “and less than four days is really good.”
Labs are dealing with tremendous volumes of tests. Yohe said the U’s lab alone is receiving 4,000 to 5,000 COVID specimens a day from clinics and other health care providers.
An antigen test is much more direct than a PCR test: It doesn’t require sending a specimen to a laboratory.
“The thing that makes them so appealing is that they can be run very quickly and in devices that are portable and can be easily set up,” said Emily Volk, a pathologist at the University of Texas-Health in San Antonio and president-elect of the College of American Pathologists.
With the current COVID testing system’s bottlenecks — and a high demand for tests — more companies and researchers are looking at antigen testing.
“There is absolutely a need globally for decentralized [COVID-19] testing, and that is why antigen testing is of such interest right now,” said William Morice, president of Mayo Clinic Laboratories. “But it has an inherent weakness.”
An antigen test, which probes a protein that is part of the virus, is not as sensitive as a PCR test. There’s a higher chance for false negatives with an antigen test.
3M’s quest is to produce “highly accurate” antigen tests for COVID-19, said Cathy Tarnowski, the 3M scientist leading the company’s project. She is working with researchers at MIT’s chemical-engineering department led by professor Hadley Sikes.
Sikes has for years been researching antigen testing for various diseases. 3M is no stranger to the medical device business and can produce testing devices on a large scale like few global manufacturers can.
The company said it could manufacture millions of testing units per day.
The effort is part of the U.S. National Institutes of Health’s Rapid Acceleration of Diagnostics Tech. RADx Tech, as the program is called, is funded by $1.5 billion in federal stimulus money.
The 3M-MIT venture got $500,000 in RadX Tech funding for phase 1, and is eligible for further investment.
3M also is working on approval for the antigen test from the U.S. Food and Drug Administration. Two other companies have recently gotten FDA approvals for antigen-based COVID-19 tests.
3M said it couldn’t give a timeline for when its antigen test might hit the market. “All I can tell you is as quickly as possible,” Tarnowski said.
©2020 the Star Tribune (Minneapolis). Distributed by Tribune Content Agency, LLC.
