3M and researchers from the Massachusetts Institute of Technology announced Tuesday a partnership to develop a rapid coronavirus antigen test they say will be widely available in the U.S.
With new cases of Covid-19 surging across much of the country, major test manufacturers and laboratories have warned of delays in processing. Delivering quick testing results is crucial to the U.S. response to ensure that infected individuals can be quickly isolated and local public health workers can find potentially exposed people early in their infection, health officials say.
Antigen tests are a relatively new for Covid-19. They work by scanning for proteins that can be found on or inside a virus. The Food and Drug Administration has touted the tests as an important tool for combating the pandemic because they can be produced quickly, at relatively low costs, and test patients in a variety of settings.
3M and MIT’s testing device, which is in the early stages of development, would function “like a pregnancy test,” 3M senior technical manager Cathy Tarnowski told CNBC. It will be a paper-based point-of-care testing device, which will help reduce the cost, the company said.
If development goes well, Tarnowski said, 3M is looking to manufacture around 1 million per day, allowing for frequent and affordable diagnostic testing.
The device has received phase one approval from the National Institutes of Health’s Rapid Acceleration of Diagnostics Tech program, which comes with $500,000 in funding to accelerate development, Tarnowski said.
“We’re really looking forward to understanding whether we can create a low-cost, high-accuracy device to be able to detect the antigen,” she said. “Our focus right now really is understanding and demonstrating that we have a device that has the accuracy that we’re looking for.”
3M has been partnered for years with the MIT team, which is led by Hadley Sikes, associate professor in the department of chemical engineering, Tarnowski said. Seeing the testing shortage amid the pandemic, the partnership pivoted to develop an effective diagnostic test.
The partnership will help to ramp up manufacturing of the testing devices if and when they prove effective and receive FDA authorization, Sikes told CNBC. The newly announced partnership with NIH provides some financial as well as technical support, she added, and the NIH program helps to coordinate national research efforts to eliminate redundancies.
“One of the problems that we’re having is that the RNA tests that are there, people take them, but they typically take them only once,” Sikes said. “But if you’re able to do more tests and take more time points, then you have a better chance of getting the right answer.”
A major emphasis will be making the test accessible to the general public, she said, which means making it affordable and manufacturing enough that they can be widely distributed to rural and as well as urban communities across the country.
While so-called PCR diagnostic tests are typically the most accurate kind of screening that detects current Covid-19 infections, antigen tests can be processed much more rapidly, according to the FDA. However, the agency says antigen tests are typically less sensitive than PCR tests, which means they can result in false negatives that misdiagnose someone who actually has an active infection.
The FDA has authorized two antigen tests since May 8. The first one granted an 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 its test can be administered at the point of care and produce results within 15 minutes.
“The biggest challenge in the outbreak is identifying who is infectious,” Sikes said. “Trying to figure out who is infectious and having them isolate. That’s really what we need.”