SD Company's At-Home COVID Test Gets Emergency FDA Approval Amid Surging Demand

FDA expects Acon Laboratories. based in San Diego, to start producing more than 100 million tests per month by year's end

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A new at-home rapid COVID-19 test from San Diego-based Acon Laboratories was given emergency use authorization from the FDA on Monday.

It’s a move the federal health agency says could double rapid at-home testing within the next few weeks.

“By year's end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health

UC San Diego infectious disease specialist David Pride, M.D. PHD., says it could be a game-changer. He’s worked to develop a rapid test for sale overseas

“Oftentimes people who get sick with SARS-CoV-2 initially don’t think they’re sick, because they have very mild symptoms. So they'll continue to go about their daily schedule. That might be going out and about, going to the grocery store, going to a restaurant, etcetera,” explained Dr. Pride.

Rapid at-home tests are nothing new. In fact, the FDA says there are 400 COVID-19 tests and sample collection devices they've authorized since March of last year.

The problem though is accessibility. NCB 7 called around to several drug stores and it’s hit or miss whether the tests are in stock.

The White House's announcement of a billion-dollar investment in at-home testing should help change that, providing funding for companies like Acon to roll out its rapid nasal swab test. Delivering results within minutes, instead of the days it takes for the more sensitive PCR tests.

“So by increasing the number of rapid, relatively high-quality tests on the market, we can change the pandemic by allowing people to test themselves at home and, of course, quarantine themselves before they spread the virus to others,” Dr. Pride said.

An Acon spokesperson denied NBC 7's request for an interview and said the company is busy preparing for the rollout of their tests. But in a release, they noted the emergency use authorization allows them to quickly respond to unmet demand for simple, inexpensive home diagnostics to help the fight against COVID-19.

Acon's test will cost less than $10, according to the company.

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