What the Omicron Variant Could Mean for the Medical Device IndustryWhat the Omicron Variant Could Mean for the Medical Device Industry
Diagnostic companies were quick to confirm their tests' efficacy against the new variant of concern, but is medtech prepared for more COVID-19 disruption?
November 29, 2021
Even as hospital systems around the world continue to battle the Delta variant of COVID-19, the Omicron variant of the virus has sparked worldwide concern. The World Health Organization (WHO) dubbed Omicron a "variant of concern" late last week.
WHO says it is still not clear whether Omicron is more easily spread from person to person compared to other variants of the virus that causes COVID-19. The organization also said it is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including Delta. Preliminary data suggests that there are increasing rates of hospitalization in South Africa, WHO noted, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron.
If the Omicron variant does become more widespread globally, however, we can be relatively sure that elective surgery and "deferrable" surgical procedures will once again take a backseat to COVID-19, especially in places like the United States where hospitals are facing major labor shortages.
COVID-19 surges attributed to the Delta variant, combined with the hospital staffing shortages, proved to be a double whammy on earnings for several medical device companies in the third quarter, including Stryker. While some executives in the industry spoke optimistically about how hospitals are getting better at juggling COVID-19 cases with surgical procedures, that optimism will truly be put to the test if Omicron continues to spread as quickly as it has.
Current COVID-19 tests still useful for detecting Omicron
Diagnostic companies that develop COVID-19 tests, on the other hand, will continue to benefit from testing demand. WHO said the widely used polymerase chain reaction (PCR) tests for the virus continue to detect infection, including infection with Omicron, as they have with other variants. The organization said studies are ongoing to determine whether there is any impact on other types of COVID-19 tests, including rapid antigen detection tests.
Companies at the forefront of COVID-19 testing were quick to confirm over the weekend that their current tests are capable of detecting the Omicron variant.
Abbott, which is currently manufacturing more than 100 million COVID-19 rapid and PCR tests every month, said the company has already conducted an assessment of the Omicron variant, and it is confident that its rapid and PCR tests can detect the virus.
"While the Omicron variant contains mutations to the spike protein, Abbott's rapid and molecular tests – antigen, PCR, and NAAT – do not rely on the spike gene to detect the virus," Abbott said in a statement. "The process for evaluating variants and stress-testing our tests doesn't stop with the current variants. We are actively collecting real-world samples and using viral cultures to verify that our tests continually detect circulating strains because we know how important it is that our tests can detect new variants regardless of where they are found."
The company said that as soon as the Omicron sequence was made available, Abbott scientists "worked non-stop" to evaluate it and determined the mutations would not impact the ability of Abbott's rapid and PCR tests to detect it.
Thermo Fisher Scientific confirmed on Monday that its PCR TaqPath COVID-19 combo kit and TaqPath COVID-19 CE-IVD RT-PCR kit are not impacted by the emerging Omicron variant.
Thermo Fisher said the TaqPath COVID-19 assays detect SARS-CoV-2 infections by identifying the presence of three gene targets from the orf1a/b, S, and N regions of the virus. By surveying across multiple genes, the test can report accurate results even in the case where one of the targets is impacted by a mutation, the company explained. While the S gene target in the test is impacted in the presence of Omicron variant mutations, the orf1a/b and N gene targets in the TaqPath COVID-19 tests have been determined to not be impacted by any of the mutations in the Omicron variant, based on assessment of sequences in the public database. As a result, the overall accuracy of the TaqPath COVID-19 assays is not impacted, the company emphasized.
The Omicron variant has been found to include the 69-70del mutation of the S gene, first identified as a mutation in the Alpha variant. This mutation causes a dropout of the S-gene target in results from the TaqPath test, which could indicate to clinicians and researchers a possible Omicron variant infection. Confirmation must then be performed by sequencing the sample.
"The Thermo Fisher test allowed us to detect cases that may contain the new variant by identifying samples exhibiting S-gene dropout," said Tulio de Oliveira, director of the Centre for Epidemic Response and Innovation, Stellenbosch University and UKZN, South Africa. "This early identification is very important in helping us track and understand the spread of the B.1.1.529 variant to South Africa and the world."
In addition to the original TaqPath COVID-19 tests, Thermo Fisher has developed the TaqPath COVID-19 2.0 tests with an advanced assay design to compensate for emerging mutations. The TaqPath COVID-19 2.0 assays are designed to detect the presence of SARS-CoV-2 by using eight gene targets across the orf1a/b and N regions of the virus. These assays were also assessed against sequences in the public database and confirmed in silico to detect all B.1.1.529 mutations with no loss in sensitivity.
"Like all viruses, we have always known that SARS-CoV-2 would continue to mutate, and that effective testing strategies are a key to curbing the pandemic," said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. "That is why we developed assays with additional built-in checks and balances, to ensure that clinicians, researchers and public health officials would have effective tools to accurately test for COVID-19 even as the genetic makeup of the virus evolved."
Specific genotyping assays to detect the Omicron variant are being developed for Thermo Fisher's TaqMan Mutation Panel. The panel, which is currently used for research purposes, already has a menu of more than 50 assays to assess confirmed COVID-19 cases for the presence of known variants and mutations.
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