New Abbott Labs Rapid Coronavirus Test Receives FDA Authorization

GREEN OAKS, IL — Abbott Laboratories received emergency use authorization from the U.S. Food and Drug Administration Wednesday for a rapid coronavirus test that it plans to sell for $5 each. The new test is about the size of a credit card, requires no additional equipment, and will provide results within 15 minutes, company officials announced.

Abbott Labs will be able to ship tens of millions of the new tests — called the BinaxNow COVID-19 Ag Card — next month with a goal of producing 50 million tests a month by the start of October, according to company officials. They said Abbott has spent hundreds of millions of dollars since April to manufacture new tests at a massive scale.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement following Wednesday's emergency use authorization. "This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic."

The test is conducted using nasal swabs. It functions similar to a pregnancy test — an additional line appears on the card when a sample tests positive for the COVID-19 virus.

Under its use authorization, the card is intended for use by healthcare professionals in qualified settings. With minimal training and a prescription, the test can be performed by school nurses, medical assistants and technicians, pharmacists and occupational health specialists, according to the company.

"Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic," Dr. Charles Chiu, professor of Laboratory Medicine at University of California, San Francisco, said in a statement from Abbott announcing the authorization. "The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it."

Antigen tests are cheaper to produce and deliver results faster than molecular diagnostic tests performed in labs, but they have also been found to be less accurate. FDA officials said their reduced sensitivity means negative tests may need to be confirmed with additional molecular tests before treatment decisions are made.

"Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information," according to the FDA statement.

According to Abbott officials, the new test is 97.1 percent accurate in identifying positive results and 98.5 percent accurate in identifying negative results when administered to people with suspected cases of COVID-19 within a week of their first symptoms.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, a virologist working on COVID-19 testing at Baylor College of Medicine.

"With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results," he said. "With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."

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Abbott officials said BinaxNOW tests can be used to check large groups of people at workplaces, schools and other gatherings. To accompany the new tests, the company also announced a downloadable mobile app intended to provide proof of recent negative test results. It's the first such app in the United States, although similar measures have been adopted in China in an effort to stem the spread of the coronavirus.

The app, dubbed Navica, is free and not mandatory, according to Abbott. The optional tool works with both Apple and Android digital wallets.

People who test negative for the virus can display a QR code on their phones, like with a boarding pass for a plane. The "digital health pass" is stored temporarily and is only valid for as long as the organizations that accept the app results choose.

Robert Ford, Abbott's president and CEO, said the new test and accompanying app offer the chance for people to have "a bit more normalcy" in their daily lives.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Ford said.

The app is not used for contact tracing and only collects a person's name, age, ZIP code, contact info and test results, according to the company.

"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," he added. "We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."

Shares in Abbott Labs were up by more than 9 percent Thursday, a new high, according to Bloomberg News. As of the afternoon, the company's stock had risen by nearly 30 percent so far in 2020 as of the afternoon. A spokesperson told the Chicago Tribune the company plans to hire 2,000 temporary workers at a new facility in Gurnee to help produce the tests.

The testing card is sixth coronavirus test developed by the north suburban company. The company has produced more than 27 million coronavirus tests in the U.S. to date. Of those, about 14 million were diagnostic tests to detect active COVID-19 cases and 13 million were antibody tests, which detect earlier infections.

This article originally appeared on the Lake Forest-Lake Bluff Patch