Developing a fast COVID-19 that resembled a pregnancy test and building two factories to boost production — those were but two of the quick-thinking actions that Abbott (NYSE:ABT) officials took in the early months of a deadly coronavirus pandemic.
Abbott began tracking the virus in China at the end of 2019 and into early 2020. By February, the company had an internal meeting to discuss its plan of action as the virus began to spread rapidly and was introduced to the U.S. The World Health Organization declared the COVID-19 outbreak a pandemic on March 11, 2020.
“We knew this virus was different. The outcome was spreading across the globe,” Andrea Wainer, executive VP of rapid and molecular diagnostics at Abbott, said during a CES 2021 panel. “Diagnostic players were going to need to play a role.”
Customers started asking Abbott in February to develop tests. At that time, there were only 72,000 cumulative cases worldwide, according to the Johns Hopkins University of Medicine coronavirus resource center. The worldwide reported case count later surpassed one million on Apr. 2, 2020.
Abbott developed three molecular diagnostic tests for the SARS-CoV-2 virus within a 30-day time span — months shorter than what typical diagnostic tests take to develop. The company launched the m2000 RealTime SARS-CoV-2 testing system and ID Now molecular point-of-care rapid test in March and the Alinity m molecular test. The company also launched its BinaxNow professional-use test in August.
“When you’re talking about a new test and a new virus, it could take years… not weeks, in which we’ve done,” Wainer said.
Abbott’s push into COVID-19 testing wasn’t without challenges. The FDA, for example, warned in May 2020 on the accuracy of Abbott’s rapid COVID-19 diagnostic test ID Now. A preliminary study at New York University found that the test missed up to 48% of positive results. Cleveland Clinic researchers in April last year also reported that ID Now had a false-negative rate of 14.8%.
As a result, Abbott began advising customers in mid-April that ID Now was not designed for use with viral transport media. It also recommended using dry nasal swabs to collect samples. The company also said that data from further studies suggested that ID Now performed best in people who tested earlier after they first began experiencing symptoms.
Abbott was just one company of many working on diagnostic tests. The FDA authorized more than 300 COVID-19 tests and collection kits in 2020. They included 235 molecular diagnostics, 63 antibody tests and 11 antigen tests as of Dec. 28.
In 2020 alone, Abbott distributed more than 300 million COVID-19 diagnostic tests. For comparison, the company distributed 15 times more COVID-19 tests than it did flu tests in 2019. Abbott expects the demand for tests in 2021 to be even higher as populations start to return to work and school.
Getting BinaxNow into the home to return to normal
Abbott started developing its BinaxNow COVID-19 Ag Card antigen test in April when coronavirus cases were still relatively low. A healthcare provider swabs the nose of a patient suspected of having COVID-19 and twirls the sample on a test card, like those used in some pregnancy tests, with a testing reagent added. Within 15 minutes, the test displays one line for a negative result and two lines for a positive result.
In a clinical study, BinaxNow has shown to have a 97.1% sensitivity (positive percent agreement) and a 98.5% specificity (negative percent agreement) with people who are suspected of having COVID-19 and who have the test done within seven days of exhibiting symptoms.
Wainer said that Abbott saw the scale at which rapid tests needed to be manufactured. It began construction on two factories to make 50 million BinaxNow tests in a month. Abbott worked over the summer to get the BinaxNow test ready to launch, and it hit the market in August.
“Rapid antigen tests can be done much more affordably and much more at scale,” Wainer said. “Our whole vision with the rapid antigen test is access.”
The BinaxNow test was designed to expand access, she added. Abbott partnered with telehealth provider eMed to be able to send a COVID-19 diagnostic test to a patient and have eMed guide the patient to run the test from their home and interpret the results. The results are also available through an accompanying mobile app that can send positive results to a healthcare provider to determine the next steps.
Future demand for diagnostic tests
COVID-19 cases continue to be at an all-time high. As of January 12, worldwide cases total 91 million since the start of the pandemic and cases in the U.S. total 22.6 million. Abbott plans to distribute 30 million BinaxNow tests in the first quarter and 90 million in the second quarter through eMed as populations continue to move toward normalcy with continued vaccine rollout.
“Testing is a critical line of defense,” Wainer said. “It needs to be used in context with other hygiene tasks like wearing a mask and washing your hands. [Testing] is not a replacement.”
The frequency of testing could be critical as parts of the world start to open back up. With the Binax rapid test, people can get a COVID-19 test and use the app with the test results as a digital pass before entering environments like schools and offices to show a person is negative and safe to enter, according to Wainer.
Abbott expects to produce and distribute more rapid tests at the beginning of this year, but more antibody tests by the end of 2021 as vaccine rollout continues. The company also expects to make and distribute more flu tests by the end of the year as more of the world receives the COVID-19 vaccination and herd immunity starts to take hold.
“Needs are going to continue, but the volumes are what is uncertain,” Wainer said. “We just need to make sure we have the capacity.”