Like many people throughout the world, Matthew Binnicker, Ph.D., remembers exactly where he was and what he was doing when COVID-19 was classified as a pandemic. “Those first few months of the pandemic will be forever ingrained in my memory,” he says.

For Dr. Binnicker, director of Mayo Clinic’s Clinical Virology Laboratory, two important dates stand out above the rest. “One was Feb. 17, 2020, when Dr. (William) Morice and I were talking about whether the department should invest the resources into developing a test to diagnose COVID-19,” he says. “We of course decided that day to forge ahead with developing a novel test for COVID-19. The second date was March 12, 2020, when we first started testing for COVID-19.”

Less than one month after deciding to develop a novel test for COVID-19, Mayo Clinic delivered an accurate and rapid way to diagnose COVID-19 by building a new diagnostic test from the ground up. It was an unprecedented accomplishment that required an around-the-clock, all-hands-on-deck approach to test development.

“I remember vividly the hard work of the lab staff and the commitment of the team that was involved in developing our test for COVID-19,” Dr. Binnicker says. “I remember being in the lab with members of that development team at 11, 12 o’clock at night troubleshooting and working to get that test brought up as quickly as possible.”

Accelerated innovation

Since offering its first COVID-19 test on March 12, 2020, Mayo Clinic has gone on to provide more than 7 million COVID-19 tests to patients, a feat Dr. Binnicker says highlights the pandemic’s impact on diagnostic innovation — not only at Mayo Clinic, but across the field of laboratory medicine and pathology. “I truly believe the COVID-19 pandemic had a dramatic impact on laboratory testing and likely accelerated innovation by 5 to 10 years,” Dr. Binnicker says.

“One of the silver linings of the pandemic is that we saw a pace of innovation that I hadn’t seen before in terms of diagnostic test manufacturers working with clinical labs and public health labs to bring up new innovations and new diagnostic tools.”

In 2020 alone, that accelerated pace of innovation helped Mayo Clinic Laboratories develop:

• Multiple COVID-19 testing platforms, including molecular (PCR) testing to diagnose active COVID-19 infection; serology testing to identify people who previously had COVID-19 or responded to vaccination; and COVID-19/influenza multiplex testing.
• 14 new COVID-19-related tests, with an average turnaround time of two days.
• 15 innovation workstreams for COVID-19.
• New COVID-19 testing collaborations with the travel industry, the United States government, and other global partners.
• 256 unique community collection events at 135 unique locations.
• Individual testing partnerships with schools, local emergency management services, and those experiencing homelessness.  
• Its own 3D-printed mid-turbinate swab.
• Partnerships with test manufacturers to develop at-home or point-of-care diagnostic solutions.

Developing the nation’s first COVID-19 tissue test

Mayo Clinic Laboratories was also the first diagnostic laboratory in the country to develop a test to diagnose COVID-19 in tissue samples, which no longer required health care workers to be reliant on nasal swabs or saliva samples to accurately diagnose the virus.

That first-of-its-kind test, Severe Acute Respiratory Syndrome Coronavirus 2, RNA Detection, ddPCR, Tissue (Mayo ID: SCOVT), accurately detects SARS-CoV-2 in formalin-fixed, paraffin-embedded tissue. In an Eye on Innovation feature published shortly after the test’s release, Anja Roden, M.D., a medical director in Mayo Clinic's Immunohistochemistry Laboratory who was involved in the test’s development, said Mayo Clinic Laboratories’ COVID-19 tissue test helped to fill an important need in COVID-19 detection. “We did not have an assay to identify SARS-CoV-2 in tissue,” Dr. Roden said at the time. “Now this assay can detect the virus not only in the lungs but also in other tissue, which will enhance our knowledge of the virus overall.”

Increased access to testing

Along with the development of new tests that have helped health care workers better detect and diagnose COVID-19, another silver lining of the COVID-19 pandemic, according to Dr. Binnicker, is how much easier and more achievable it’s become for patients in remote settings to get access to the testing they need, whether that be at home or in point-of-care settings. “We’re already seeing at-home testing solutions for COVID-19 and influenza, and the U.S. Food and Drug Administration has also now approved the very first over-the-counter, at-home molecular test that can diagnose someone with either COVID-19 or influenza,” Dr. Binnicker says. “That’s going to be a very important tool going forward because rather than requiring a patient to come into the clinic to get a swab and exposing others to their illness, they can now get a very accurate test and perform it at home to diagnose two very common respiratory illnesses. We likely wouldn’t have observed this pace of innovation in the absence of the COVID-19 pandemic.”

All told, the accelerated innovations in testing and access to testing that have come about because of the COVID-19 pandemic have not only changed the way laboratory testing is done, but also the way some test samples are received by diagnostic laboratories. “We’re also talking about new ways that we can provide more convenience and comfort for patients because of the lessons we’ve learned during the pandemic. There is an increasing desire to have more care performed outside of the clinic or hospital — for example, at-home sample collections that can be sent into the laboratory for testing,” Dr. Binnicker says. “During the past three years, we’ve also implemented new ways of interacting and interfacing with patients through virtual appointments. So, despite the significant challenges of the pandemic, there have been some silver linings.”

Watch the video below for more on how operational and diagnostic innovations have helped Mayo Clinic Laboratories meet the world’s COVID-19 testing needs since the beginning of the pandemic.

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