The SARS-CoV-2 DxBook launched in April, during the first few weeks of widespread lockdowns, and the team has diligently collected data on testing behaviors at hospitals around the country ever since. By the end of July, we had data on 400 labs’ diagnostic and serology testing. We have now launched round 2, returning to labs previously interviewed to offer our clients insight into changes in testing behavior over time. Here, we take a retrospective look at the trends we observed during round 1 from April to July as well as preliminary insights from round 2 and we discuss which patterns we expect to shape the coming months of SARS-CoV-2 testing.

1. Platform and logistical barriers fall, but challenges remain

According to JHU, the United States, on average, conducts 206 tests per 100,000 of the population. While daily coronavirus cases in the U.S. fall, accurate and adequate testing requirements lag. The DeciBio database doesn't suggest respite, in terms of testing, as demonstrated by interviewing 400 labs in the U.S. between May-July.Low- and moderate-throughput instruments continue to dominate the data (>50% of labs report using Cepheid instruments, while it ranks in the bottom quartile of labs in terms of avg volume per platform) in terms of install base, suggesting that high throughput platform reimbursement rates have not affected labs’ performance and vendor choice.In a blog post in May, we described the stopgap measures labs have been taking to meet testing needs rapidly, deploying multiple platforms simultaneously to process as many COVID samples as possible. This practice has persisted; labs continue to rely on multiple platforms to address rising testing requirements.

2. Variable inputs take over as the dominant constraint

By summer, labs had largely worked out early adoption challenges around installing systems and establishing logistical workflows. Instead, variable inputs - kits and technician time - became the primary constraints. Of labs interviewed between April and July, ~50% have reported that kits were unavailable in the necessary quantities to meet demand; preliminary round 2 data collection since August has shown no decrease in this amount. Additionally, due to quarantine restrictions in spring and summer, multiple labs reported staffing shortages and reduced operational hours that affected test processing volumes. These constraints have largely resolved since August as quarantine restrictions have loosened. We anticipate that the primary constraint to testing capacity will remain reagent supply as production continues to expand but demand increases due to increased re-openings across society.

3. Serology testing expands in late spring, then improvements slow

When diagnostic testing entered the market, serology testing followed promptly; major players were releasing serology tests as early as mid-April. While diagnostic test adoption progressed rapidly, however, serology testing lagged. While hopes for expanding serology testing widely were motivated by interest in a rapid “return to normal” and hopes of widespread immunity, implementation and wide adoption were complicated by unreliable test quality and inconclusive scientific evidence for sustained immunity.

By early summer, perceptions of the practicality of mass serology testing cooled, and hospital test adoption rates plateaued. Today, public health officials and private players continue to prioritize diagnostics over serology testing. Given continued challenges meeting diagnostic needs at scale and low uptake of routine antibody testing, serology testing is expected to remain at low (~50%) penetration in hospital labs through the coming months.An eventual vaccine rollout remains the largest development on the horizon in the coming months, and we expect trial success to be the main force shaping the next phase of the pandemic. One or more successful vaccine approvals will require a second burst of production ramp-up akin to that observed during early test roll-out; lingering volume constraints observed today in testing may indicate the potential for supply chain challenges during vaccine production as well. Should one or more vaccines gain approval in the coming months, we expect diagnostic and antibody testing pressures to slowly ease depending on vaccine availability, efficacy, production quantities, and adoption.

Julia daniel

Julia is a Senior Analyst at DeciBio with a focus on health technology, clinical diagnostics, and the impact of machine learning on precision medicine. Julia’s work at DeciBio includes market intelligence, voice-of-customer research, and data tools development. Connect with her on LinkedIn or reach out at daniel@decibio.com.

TRPTI SANGHVI

Trpti is a Data Analyst at DeciBio where she develops business intelligence products and services for companies in the research tools, clinical diagnostics, and health technology markets. She has experience building dynamic data visualizations, competitive intelligence tools, and market models. Connect with her on LinkedIn. Or reach out to her at sanghvi@decibio.comDisclaimer: Companies listed above may be DeciBio clients and/or customers