3M and researchers from the Massachusetts Institute of Technology announced a partnership Tuesday to develop a rapid test for a coronavirus antigen that they say will be widely available in the U.S.
With new Covid-19 cases across much of the country, major testing manufacturers and labs have warned of processing delays. Delivering rapid test results is crucial to the US response to ensure that infected people can quickly isolate themselves and that local public health workers can find potentially exposed people early in their infection, health officials say .
Antigen tests are relatively new to Covid-19. They work by scanning for proteins that can be found inside or inside a virus. The Food and Drug Administration has touted testing as an important tool in fighting the pandemic because it can occur quickly, at relatively low costs, and evaluate patients in a variety of settings.
The 3M and MIT test device, which is in the early stages of development, would work “like a pregnancy test,” 3M senior technical manager Cathy Tarnowski told CNBC. It will be a paper-based point-of-care test device, which will help reduce cost, the company said.
If development goes well, Tarnowski said, 3M is looking to manufacture around 1 million a day, allowing for frequent and affordable diagnostic tests.
The device received phase one approval from the National Institutes of Health’s Rapid Diagnostic Acceleration program, which comes with $ 500,000 in funds to accelerate development, Tarnowski said.
“We really hope to understand if we can create a low-cost, high-precision device to be able to detect the antigen,” he said. “Our focus right now is really understanding and demonstrating that we have a device that has the precision that we are looking for.”
3M has been partnering for years with the MIT team, which is led by Hadley Sikes, an associate professor in the department of chemical engineering, Tarnowski said. Seeing the paucity of evidence amid the pandemic, the association turned to develop an effective diagnostic test.
The association will help speed up the manufacturing of the test devices as long as they are effective and receive FDA clearance, Sikes told CNBC. He added that the recently announced partnership with NIH provides some financial and technical support, and the NIH program helps coordinate national investigative efforts to eliminate layoffs.
“One of the problems that we’re having is that the RNA tests that are there, people take them, but they generally take them only once,” Sikes said. “But if you can do more tests and take more time points, then you have a better chance of getting the correct answer.”
A major emphasis will be making the test accessible to the general public, he said, which means making it affordable and manufacturing enough so that it can be widely distributed to rural and urban communities across the country.
While so-called PCR diagnostic tests are often the most accurate type of detection that detects current Covid-19 infections, antigen tests can be processed much more quickly, according to the FDA. However, the agency says that antigen tests are often less sensitive than PCR tests, which means they can lead to false negatives that misdiagnose someone who actually has an active infection.
The FDA has authorized two antigen tests since May 8. The first with emergency use authorization is produced by Quidel and the second, which was authorized for emergency use last week, is produced by Becton Dickinson. Becton Dickinson said his test can be administered at the point of care and produce results in 15 minutes.
“The biggest challenge in the outbreak is identifying who is infectious,” Sikes said. “Trying to find out who is infectious and have them isolate themselves. That’s really what we need.”
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