CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could perform. Today, with the demand for COVID-19 PCR tests dropping steadily, these same labs now must decide which systems to keep active and which systems to take out of daily service.
WITH THE PANDEMIC EASING, CLINICAL LABORATORIES across the nation are confronted with a common problem: what to do with all the PCR (polymerase chain reaction) analyzers they bought to meet the urgent demand for huge numbers of molecular COVID-19 tests.
The numbers tell the story of the substantial overhang of PCR instruments that exists today in the United States. As medical laboratories deployed multiple testing methodologies during the SARS-CoV-2 outbreak, molecular testing became a $23.9B global market in 2020, nearly tripling in size from $7.7B in 2019!
That growth continued, with estimates that it will be $33B worldwide in 2021, according to data compiled by IVD Logix from in vitro diagnostics (IVD) companies’ sales volumes. The Dallas-based firm offers IVD strategic consulting and market research. The global molecular SARS-CoV-2 market, in particular, was $17.2B and expected to be $26B in 2021, IVD Logix data show.
“Molecular testing increased dramatically in 2020 and continued in 2021. In 2020, other testing disciplines decreased in volume because of the decrease in patient procedures in hospitals. As a result, labs diverted resources to accommodate an increase in SARS-CoV-2 volume,” said Lawrence Worden, Principal, IVD Logix, in an exclusive interview with The Dark Report.
Clinical labs were purchasing open PCR platforms used for genetic testing in genetic labs. “They were commandeering the platforms and diverting them from their regular tests to SARS-CoV-2,” Worden added. “Labs still had difficulty meeting demand. Many of them were scrambling to bring in additional platforms wherever they could find them.”
Too Many PCR Analyzers
Now, as the pandemic appears to be waning and COVID-19 test orders are declining, Worden says labs have too many PCR instruments on-hand. Lab administrators and pathologists may need to make some decisions about what to do with them.
“There’s going to be a backlog of deferred menu additions to prior platforms that will occur once SARS-CoV-2 subsides. That will cover a portion of the excess capacity,” Worden said. “But some labs will have to answer: ‘How am I going to use this equipment? Mothball it? Sell it? What should be done with it?’”
A survey from the Association for Molecular Pathology (AMP) found that 80% of academic medical centers and community hospital/health system labs used three or more testing methods for COVID-19. And large healthcare systems used seven or more methods, Worden said.
“So, it was a whole new arrangement of test volume and test location within laboratories and a total concentration on SARS-CoV-2 testing,” Worden added.
- He highlighted these possible solutions for excess PCR analyzers:
- Seeding equipment in new sites.
- Finding value in sample-to-answer platforms.
- Expanding testing menu on platforms.
Put Analyzers in New Places
“Some labs will want to hold onto the new testing platforms they purchased during the pandemic,” Worden said. “Some health system labs may find ways to seed CLIA-waved or moderately complex instruments in physician practices or other sites.
“Clever lab managers will take advantage of the available PCR platforms,” he continued. “There will be some dissemination of testing throughout the health network. These instruments could be placed in remote labs where they may not otherwise have offered tests. For example, they might support laboratory testing at a remote site with the Abbott ID NOW COVID-19 test (a portable rapid molecular test).”
Most clinical laboratories may have not contemplated putting these PCR instruments in satellite lab facilities. The labs may not have contemplated such ideas before, because they did not want to make the investment. But now they have available technology.
“Pre-pandemic, lab managers may not have thought it cost-effective to perform PCR tests at other locations or made that expense,” Worden observed. “But now they have this inventory. And instruments can be seeded in appropriate places that have the volume to justify the quality control burden, the training, and the management of overhead required of systems in alternative sites.”
Lab leaders may need to creatively use the equipment they have instead of reaching for something new. According to Worden, healthcare organizations are tapped out by the costs of the pandemic, and not much capital remains in many organizations’ coffers for new technology.
“Labs will have to adapt the equipment they have for future testing. Due to the pandemic, a lot of capital budgets in these institutions are exhausted. The market for new equipment placements will be limited by available capital for new acquisitions,” Worden said.
“The focus of the industry and the laboratory is going to be on use of the installed base of equipment that resulted from the pandemic,” he continued, noting that expansion of the respiratory test menu on the platforms is an option for labs to offer in primary care sites.
“There’s the possibility they could expand the menus on these near-patient or point-of-care platforms to include new sexually-transmitted-infection lab test panels,” Worden pointed out.
Rise of At-home Lab Testing
The pandemic also accelerated a shift to at-home testing, especially respiratory testing, he noted. Worden spoke on this topic during his presentation, “How COVID-19 Forever Changed the In Vitro Diagnostics Marketplace: What Both Clinical Labs and IVD Companies Need to Know about the Growth of Consumer At-Home Testing and Other Key Trends,” at the Executive War College on Nov. 2.
“We were doing a lot of work with companies prior to the pandemic—looking at respiratory testing that can be purchased at pharmacies and done at home. It required a healthcare infrastructure change because test results need to connect from Bluetooth to a smartphone app and to a caregiver,” Worden explained. “Much of that infrastructure is in place, and it is possible it may soon be used for regular testing as well as SARS-CoV-2,” he concluded.
Winners in the Automated PCR Marketplace Will Be Sample-to-Answer Platforms
ONE CONSEQUENCE OF THE COVID-19 PANDEMIC is that many clinical laboratories and anatomic pathology groups in the United States bought PCR instruments and SARS-CoV-2 test kits from multiple vendors.
Today, it is common to find a hospital or health system laboratory that has operated PCR instruments manufactured by three to five different vendors. In the early days of the outbreak, this was one lab management strategy to obtain enough throughput and test kits to serve the needs of the parent hospitals.
Now that much of the population is vaccinated and daily new cases of COVID-19 are declining, labs must decide which PCR platforms to keep and what to do with the remaining instrument systems.
Experts say that the PCR technology likely to be kept and used by integrated delivery systems are the automated sample-to-answer platforms. Some of these systems extract a virus’ genetic material or DNA/RNA as part of the process and enable results in less than an hour, explained a blog article from DiaSorin Molecular, developer of the Simplex COVID-19 Direct Kit (which eliminates RNA extraction).
Other higher-volume systems, such as the Roche Cobas 6800 or Abbott Alinity systems, reportedly require a sample prep and extraction process but integrate it into a single automated instrument. These systems are more likely to remain in central laboratories but will be used for a broader menu than just respiratory pathogens.
In contrast to sample-to-answer systems, there are open PCR platforms that require separate steps to extract DNA or RNA, purify, and amplify or multiply the virus genetic material, even before the specimen is on the instrument. Higher qualifications of medical technologists are needed, and these systems potentially require validation of laboratory-developed tests (LDTs) that are run on these analyzers.
In a study conducted by IVD Logix, a consulting company, respondents indicated a preference for sample-to-answer platforms that pair with U.S. Food and Drug Administration-cleared assays, compared to LDTs (laboratory-developed tests). “Sample-to-answer PCR platforms don’t require specially-trained medical technologists, and they will probably be the ones labs will keep as they have broader application and lower overhead,” stated Lawrence Worden, Principal of IVD Logix.
Even labs with the wherewithal, staff skill level, and CLIA certificate to develop and run their own LDTs may choose not to take this approach, according to IVD Logix research.
“In a study we recently conducted of highly complex molecular labs, we found that approximately 20% will only adopt FDA-cleared assays, 45% would adopt an LDT if there is no FDA-cleared alternative, and 35% are equally open to either,” Worden noted.
Similarly, a survey done by the Association for Molecular Pathology (AMP) found that 62% of labs used COVID-19 testing kits with FDA emergency use authorization (EUA), 5% tapped LDTs only, and 26% relied on a combination of EUAs and LDTs.
Contact Lawrence Worden at 214-364-0119 or firstname.lastname@example.org.