4:13 PM, Feb 27, 2020


Getting Tested Faster, Companies Developing Tests To Take At Home

Posted at 11:00 PM, Nov 27, 2020

LANSING, Mich. — For most of us, Thanksgiving will look different this year. Dinners outside, social distancing -- or passing on family gatherings altogether. As we all hope to rebound from the pandemic our Amanda Brandeis is asking how soon until we'll able to able to take a simple at-home test before going to a holiday dinner or party.

From food allergies to pregnancy – we rely on tests to help us prepare for the future. Tony Lemmo, CEO of Biodot “I got to understand the diagnostics marketplace years ago and thought it was an underserved part of market for healthcare.

"Technology from the company Biodot has been helping companies make these tests for decades. “It’s like an ink-jet printed drop of fluid.” Their machines dispense tiny droplets of fluid on testing devices – accurately and fast.

“A system like this, run under what i would say typical conditions, could probably produce between 50 and 75 million tests a year” and now over 70 manufacturers are using these systems to make COVID tests.

CEO Tony Lemmo says they've decreased production time from months to weeks, building a new facility to meet customer demand. “For people to feel comfortable to associate with friends or family there needs to be a testing methodology ideally that can be performed at home,” one that provides quick results, similar to a pregnancy test.

“Would be smaller than this”the FDA's approved one rapid at-home test that gives results in 30 minutes - but getting it will require a doctor’s prescription. Testing companies hope the FDA will soon authorize a different type of at-home testing tool - the rapid antigen test.

"Two lines would be positive, one line would be negative." The inexpensive tests provide results within minutes - companies developing them believe millions could be sold without a doctor's referal but they're less accurate than the tests done in a lab.

Dr. Melissa Miller, Clinical Lab Director “So i worry, you're going to have mass testing at home. you’re going to have false positives, you’re going to have false negatives, and people aren’t going to trust testing.”

Clinical Lab Director Dr. Melissa Miller believes scaling at-home testing should be done with caution.“ Even at 98% specificity, which is very high, that means you’re going to have a false positive 2 of every 100 people. If you started testing a hundred million people, this is millions of people who have a false positive test” and a false negative result could give a false sense of security.

“These rapid antigen tests were pushed out to skilled nursing facilities, this is a very high-risk patient population, this is actually where you want a very accurate test” and she says it’s unclear how well they detect the virus in people with no symptoms.

“It might make more sense for K-12 schools, or even college settings, where there’s less risk for a poor outcome if you have a false positive or a false negative.”But with a growing demand for convenient testing, manufacturers are hopeful that in the months ahead, the FDA will open the door to new solutions.

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