Four years ago Abbott sought to get out of its acquisition of point-of-care diagnostics manufacturer Alere amid billing concerns and a recall. The deal ultimately went through in 2017 for $5.3 billion as one of the last big M&A plays under CEO of 21 years Miles White.
Fast forward a few years and massive demand for coronavirus testing prompted Abbott to, in a matter of months, more than double the U.S. footprint of the portable diagnostic machines descendent from Alere and typically used to test for infections like strep and flu in doctor's offices.
Speaking to investors in October, newly minted CEO Robert Ford called the recent testing expansion "the execution of that Alere strategy, which is to build a whole new testing platform outside of the walls of a lab," adding, "COVID has actually given us an opportunity to accelerate that strategy."
Andrea Wainer, head of rapid and molecular diagnostics, said that by March of this year there was "no turning back" for Abbott's team in shifting resources to coronavirus response, and echoed Ford's sentiment, noting that previous "inertia" against point-of-care testing by those accustomed to more traditional settings has given way during the pandemic.
The Chicago-area company's ability to develop, manufacture and scale molecular, antigen and antibody tests — which resulted in $881 million in related revenues in the third quarter alone — has made it a critical player in the U.S. effort to track the virus' spread.
Timeline of Abbott's coronavirus test rollout
Abbott obtains its first EUA for a molecular coronavirus test
Abbott gains an EUA for a coronavirus test run on its portable point-of-care ID Now machines
Abbott announces launch of its first IgG antibody test, a lab-based version
Abbott expands antibody tests to its Alinity i systems
Abbott secures an EUA for a molecular coronavirus test run on its Alinity m systems
Abbott receives an EUA for an instrument-free antigen test
Abbott gets an EUA for an IgM antibody test
Abbott's coronavirus products have not been without some controversy. The 15-minute ID Now test, heralded by the Trump administration, drew early scrutiny from researchers and FDA for potentially having a higher rate of false negatives compared to other COVID-19 tests, prompting postmarket studies. Abbott shared an interim analysis in October, amid news of President Donald Trump and a host of others in the White House becoming infected with the virus. Critics questioned the administration's faith in testing via the ID Now platform as a means to surveil a population.
Still, some public health experts take the position that imperfect testing is better than a dearth of testing, and saw the West Wing outbreak more as a reflection of the White House team's improper reliance on a single type of rapid test, rather than an issue with the tests themselves.
The revenues from the unforeseen diagnostics boom also put Abbott in a unique position at the end of 2020 compared to many of its medical device peers. Many companies expect revenues to be flat when 2020 is said and done, or to be digging out of a hole in 2021 due to the sharp decline in elective procedures when the pandemic took hold, but Abbott is forecasting double-digit earnings growth this year.
"This does give us an opportunity to invest in many of the organic programs that we believed in before the pandemic," Wainer said, "and will support us to continue to invest in additional expansion opportunities in our menu to leverage the base that we built with COVID."
But diagnostics only tell part of Abbott's 2020 story.
The main growth drivers Abbott highlighted coming into 2020 were its line of Alinity core lab analyzers, MitraClip mitral valve repair device, and FreeStyle Libre glucose monitors. Each of those businesses, even though they perhaps gained less attention in 2020 than Abbott's COVID-19 tests, have all continued to make strides.
While sales of MitraClip did dip amid pandemic restrictions on surgeries, the value of a multifront approach in Abbott's medical devices business showed up in the chronic disease focus of FreeStyle Libre. Driven by individuals looking to manage diabetes without finger sticks, Libre revenues in the most recent quarter rose around 36%, about 10 points ahead of chief competitor Dexcom.
"They have such a diversification in their business model that really stands out relative to peers," said Scott Tuhy, lead medical devices analyst at Moody's Investors Service. "The benefit of that diversified model has really played out through the pandemic."
While Abbott holds firm that demand for its COVID-19 tests will continue even after a vaccine is available, the longer benefit from 2020's diagnostics boom may be how the experience has changed testing infrastructure and the behavior of healthcare providers and consumers when it comes to point-of-care testing, Wainer argues.
"What COVID was able to do was to demonstrate real-time that the benefits of moving testing outside the hospital outweigh some of the resistors."