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SARS-CoV-2 media attention has largely focused on diagnostic reference labs as they have scaled up testing capacity. However, hospital labs, which drive the vast majority of seasonal respiratory virus testing in the U.S., have received much less attention. Hospital labs offer important advantages over reference labs in the current testing environment, where long sample-to-answer time leaves patients in limbo and uses up scarce PPE. The simplified logistics of testing in local hospital laboratories also reduces the backlog at centralized hubs. Here we make sense of the fragmented landscape of coronavirus testing options currently available and examine which tests will likely most easily enter hospital laboratories, based on insights from DeciBio’s Infectious Disease DxBook.
Worldwide, there are ~100 commercially available diagnostics tests for SARS-CoV-2 coronavirus. Of these, 42 have sought U.S. emergency use authorization (EUA), 34 of which have been approved to date. While ARUP, LabCorp, Quest, and other leading private labs have developed their own tests, the vast U.S. hospital lab network is relying first on tests that are compatible with their existing installed base and in-house expertise.
The Infectious Disease DxBook provides insights into hospitals’ testing capabilities. The database curates testing behaviors and trends from 1,000+ U.S. hospital labs annually to provide high-quality, granular insights on infectious disease testing practices nationwide. Historically, hospital labs have been responsible for ~45% of total U.S. respiratory virus testing volume (including influenza, RSV, and respiratory viral panels). Of the 1.3 million hospital-based respiratory virus tests captured in 2019, ~80% are processed in hospitals with over 200 beds.
The 5 most common platforms these hospitals use for respiratory viruses cover ~2/3 of total test volume; here are leading platforms and their corresponding tests, if available:
|Platform rank by U.S. testing volume, all analytes||Platform rank by U.S. testing volume, respiratory viruses*||Platform**||SARS-CoV-2 Test||EUA Status|
|1||1||Cepheid GeneXpert and GeneXpert Xpress||Xpert Xpress SARS-CoV-2 test||EUA 3/20/2020|
|2||N/A||Hologic Panther||None; Hologic test only compatible with Panther Fusion||EUA 3/16/2020***|
|3||N/A||Roche Cobas 4800||None; Roche test only compatible with Cobas 6800/8800||EUA 3/12/2020***|
|4||3||Cepheid Infinity||Xpert Xpress SARS-CoV-2 test||EUA 3/20/2020|
|5||2||BioMerieux BioFire Film & Torch||BioFire COVID-19 test (compatible with both platforms)||EUA 3/23/2020|
|6||16||BD Max||BioGX SARS-CoV-2 Reagents for BD MAX||EUA 4/2/2020|
|13||4||Abbott ID NOW (formerly Alere i)||ID NOW COVID-19||EUA 3/27/2020|
|10||6||Luminex Verigene||None; Luminex NxTAGCoV Assay compatible with MAGPIX system, while ARIES Assay only compatible with Aries system||EUAs 3/27/2020 and 4/3/2020***|
As coronavirus testing continues to scale, we are seeing increased demand for both SARS-CoV-2 and traditional respiratory virus tests for differential diagnosis. While coronavirus tests with EUA are now available for most platforms that hospitals use, Hologic’s and Roche’s offerings face the challenge of a limited compatible installed base despite the high penetration of these companies within the hospital testing market. While many institutions will likely require new platforms in order to bring coronavirus testing in-house, influenza testing on installed coronavirus-incompatible machines remains highly valuable. As the urgent race to expand testing capacity continues, hospital labs have a critical role to play in distributing the testing burden and decreasing turnaround time, and many of their existing machines are proving valuable in the fight.
These insights were generated from DeciBio’s infectious disease market intelligence database. Stay tuned for future insights as we gather data about coronavirus testing around the U.S., and reach out to DeciBio to schedule a demo and see how our DxBooks can answer your questions.
* Includes panels that may contain respiratory viruses, bacteria, and other pathogens
** Not a comprehensive list; platforms not shown due to low existing testing volumes in hospital labs include the Thermo Fisher AB 7500, Abbott m2000, and numerous others
*** EUA granted for a test by this manufacturer, but the approved test is not compatible with the hospital-used platform listed here
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