The COVID-19 pandemic has created the need for widespread diagnostic testing for the detection of SARS-CoV-2 and antibodies in infected individuals. The medical community and laboratories across the globe rose to the occasion by rapidly developing and scaling COVID testing solutions to meet the demand for increased access to testing.
At the Precision Medicine World Conference (PMWC) recent special event “21st Century Precision Medicine in the Age of COVID-19,” Mark Stevenson, Executive Vice President and Chief Operating Officer of Thermo Fisher Scientific, joined a virtual panel on COVID-19 molecular testing to share lessons learned from decoding the virus and scaling diagnostics to address the global pandemic.
The session was chaired by Janice Chen, Co-Founder and Chief Research Officer at Mammoth Biosciences, and included fellow panelists Marcia Eisenberg, Ph.D., Chief Scientific Officer and Senior Vice President at LabCorp, Andrew Hemmert, Ph.D., Vice President of Molecular Biology at BioFire Diagnostics, Joseph DeRisi, Ph.D., Co-President at Chan Zuckerberg Biohub and Jonathan Rothberg, Ph.D., Chairman and Founder of 4Catalyzer. The following are highlights excerpted from Mark’s commentary during the discussion:
On the concept of “good enough” for diagnostic testing
Mark Stevenson: When it comes to “good enough” for testing, we need to put it in the framework of “what is the intended use?” Rapid antigen detection tests (RADT) and molecular tests (such as PCR) each have their own intended use. There are other scenarios, and they’re still evolving. Before, we were doing deep nasal pharyngeal samples, now we’ve got data out on saliva. Choice of testing modality depends on frequency of testing and level of confidence in sensitivity required.
We recently conducted a survey in North America that revealed widespread confusion on testing. This means, for the diagnostic industry, we face the challenge of truly educating what test is best for what purpose. We need to provide more clarity for the public on the intended use for each test and what is “good enough.”
On at-home testing
Mark Stevenson: At Thermo Fisher Scientific, we thought about at-home testing in two ways. One is actually testing at home and the other is home collection devices to send samples into the lab. Both are trends that are going to continue to develop as digital innovation furthers the accuracy and capabilities of at-home testing at an accelerated rate. Thermo Fisher is acquiring Mesa Biotech which had developed an affordable, easy-to-use, point-of-care PCR-based testing platform for infectious disease diagnosis. The platform enables rapid, highly accurate testing at physician offices, pharmacies and other settings, providing results in 30 minutes.
On what the demand for testing looks like in 2021
Mark Stevenson: In the short term, testing will still be necessary while the rollout of the vaccines remains at its current pace. Additionally, the new mutations, such as B.1.1.7 and others, will require ongoing testing and surveillance efforts until herd immunity is achieved. Every week we’re fighting new strains and we need a unified surveillance plan in place, in addition to sequencing and PCR technologies, not only for what might happen with the current virus mutations, but to truly understand the state of the outbreak. Having data around this will enable us to get back to life and help the economy move forward.
To date, Thermo Fisher has provided testing to more than 20,000 of its colleagues and the company is launching a voluntary testing program in early 2021 to significantly increase access to testing.
On the urgency around COVID-19 variants
Mark Stevenson: With emerging variants, we need genomic surveillance solutions to identify, detect, and confirm new and emerging SARS-CoV-2 mutations and variants whilst we focus on accelerating the vaccine rollout. S gene dropout in Thermo Fisher’s TaqPath kit may help identify potential B.1.1.7 cases, but we also need increased PCR and sequencing solutions.
On new technology development
Mark Stevenson: During the past year, we’ve seen collaboration with governments, regulators, industry and academia to accelerate precision medicine. The pandemic has illuminated the interconnectedness of diagnostics and therapies. If you can’t diagnose it, you can’t choose the appropriate therapies.
I am hopeful for not only the acceleration of technology but for the continued collaboration of our community to improve access to testing and surveillance measures.