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Months into the COVID-19 pandemic, U.S. testing capacity continues to lag behind its goals. The Harvard Global Institute estimated that the U.S should have at least 900,000 SARS-CoV-2 tests per day by mid-May. Currently, the COVID Tracking project reports a daily testing average of only 280,000 – roughly a third of that goal. This interactive graph shows tests conducted over time:
Size of the circle indicates total test results; colors represent cumulative positive test results. Use the slider or play button to start the animation. Data from the COVID Tracking project. Last updated: May 14, 2020
The WHO states that a target of 10% or lower positive test results indicates enough of the population is being tested to accurately capture the extent of infection. Among the top 5 states with the highest count of positive tests, we see states far overshooting this target:
|State||Population (M)||Total Tests (K)||Positive Tests (K)||Percent Tests |
Last updated: May 14, 2020
There thus remains an acute need to ramp up testing capabilities to determine the full extent of disease spread and transition to easing lockdown. This current capacity gap merits examination, and insights from a new DeciBio data offering show that supply-chain constraints are a common hindrance to labs seeking to increase testing capacity.
Our previous blog post detailed the advantages of leveraging hospital lab testing for the coronavirus onslaught, based on data from the DeciBio DxBooks. Since then, in an effort to understand the pandemic’s role in current testing trends and implications for molecular diagnostic testing in the future, DeciBio has launched a supplementary SARS-CoV-2 DxBook tracking ~400 labs throughout 2020. As new data comes in each day, a few key trends are emerging that highlight the supply chain constraints currently facing this industry:
1. Kit unavailability: Out of 160 interviews so far, over 40% of labs have reported that kits are unavailable in the necessary quantities to meet demand. DeciBio expects manufacturing to scale up quickly to match demand by the end of May, driven by FDA clearances (including five from Abbott) and workaround solutions (Thermo Fisher’s testing offers 4-hour turnaround and increased flexibility for reagents and consumables to manage testing pressures).
2. Throughput constraints: Low- and moderate-throughput instruments – primarily from Cepheid – dominate the existing install base across most surveyed labs, limiting testing scalability in many settings. Cepheid platforms are common features in many labs, but they do not match up to Thermo Fisher, Roche, and Abbott in terms of both theoretical throughput and observed average testing volume for SARS-CoV-2 at this time. In interviewed labs, throughput per instrument was 25% – 40% lower for Cepheid instruments than Roche or Thermo Fisher instruments. Interestingly, CMS offers a higher reimbursement for SARS-CoV-2 testing conducted on high throughput instruments, which may incentivize reliance on high-throughput platforms in the long term.
3. Multi-platform use: In order to swiftly address demand, 10% of labs we interviewed report taking the unusual step of conducting tests on multiple platforms simultaneously. These labs running mixed platforms contributed to one-third of all testing volumes.
Although diagnostic testing remains constrained, its crowded market stands weeks ahead of serology testing. While serology testing adoption in molecular labs has been slow (5% of all SARS-CoV-2 DxBook database labs to date), we hypothesize that it will ramp up in the near future in light of recent FDA clearances (Quidel). Thus far, ~20% of labs surveyed to date express plans to bring serology testing in-house.
In a final supply-chain twist, decreased screening and elective medical activity under pandemic conditions has led to a decrease in volumes for other infections, such as MRSA. Quest and LabCorp have reported plunging total test volumes. Respondents report qualitatively that some testing efforts have been redirected to manage the demand for SARS-CoV-2 testing. Furthermore, while co-testing for additional respiratory analytes in cases of suspected COVID-19 is currently low, we expect a surge in respiratory virus panels and flu panels in the coming months as the testing supply chain continues to respond to this extraordinary shock.
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 [email protected]
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 [email protected].
Disclaimer: Companies listed above may be DeciBio clients and/or customers