Surprising effectiveness levels for COVID-19 vaccine candidates have been reported in the news lately, with Pfizer and Moderna releasing company data. This rightly gives many hope, and also may lead to a question as to whether the polymerase chain reaction (PCR) and immunoassay testing for the disease we are seeing in 2020 will continue much longer.
It may be natural to suspect that if a vaccine is available, there will be fewer cases thus less reason to test. But this isn't normally the interplay between vaccines and diseases.
In its COVID-19 update report, Kalorama Information estimated that test volume was up in labs and among IVD vendors, and new technologies are becoming available. The firm, a sister company to LabPulse.com, projects a $10.5 billion market for tests related to COVID-19. This is an increase of over $1 billion dollars from the firm's August update with much of the increase based on the production and usage of antigen tests.
It is possible a vaccine solution will be developed, and it may be widely funded and distributed. Many candidates from major pharmaceuticals are in advanced phases. Unless the disease "goes away" or seems to be diminishing, the need for testing remains. Patients will present with symptoms, and they will need testing. We also would note the following:
- Despite the presence of one of the most widely used adult vaccines, hundreds of millions are earned by IVD companies selling flu tests. Kalorama details this market each year in its global IVD market report.
- This question of vaccines eliminating testing was raised with cervical cancer vaccines in relation to histology stains and HPV testing, which has only grown since the launch of Gardasil and other vaccines.
- Vaccine use will not be universal. A recent online survey of adults residing in the U.S. found that close to 70% of those surveyed would accept a COVID-19 vaccine if one were widely available. Results of the study were published in the journal Vaccine on August 20. The German daily, Süddeutsche Zeitung, reported on Sunday, citing a copy of the survey, that just over 60% of people in Germany would be willing to get vaccinated against COVID-19, a new survey has found.
- As Kalorama analyst Justin Saeks said, "It is also possible that, as is the case with many novel viruses, the virus passes through the population, on a very large scale or there may be mutations. So far, journal literature is leading the other direction, that mutations are not as likely because of error correction systems in the viral DNA." Yet the point remains -- for market modelers and diagnostic industry watchers, it is still possible that COVID-19 might form strains and variants or co-infect with RSV and influenza in typical ways.
- Antibody tests have been developed and are in a sense ready and waiting. Labs will likely see higher demand for antibody tests after a vaccine is available to test effectiveness post-vaccination and to test for how long immunity lasts.
- Patients presenting with symptoms will still need testing. At minimum COVID-19 remains a major testing application for 2021 and likely into 2022.
- Combination tests such as those offered by Quidel, Quest, LabCorp, Cepheid, and other makers group COVID-19 with other tests. This will be useful to rule out COVID-19 even after a period of wide vaccine usage. The ability to run COVID-19 as a panel as opposed to a single test will facilitate more testing.
It is fair to say that a COVID-19 vaccine may reduce the great expansion of SARS-CoV-2 testing, especially testing that extends to asymptomatic populations. Reopening plans in the U.S. and other developed countries will drive markets, and that creates additional unknowns beyond the medical concerns.
Right now, though, all indications are in the opposite direction, that broad testing is gaining popularity. This is facilitated by rapid antigen tests, most of which are performed at the point of care, that detect viral particles rather than antibodies in the patient. They are seeing usage, though perhaps not to the level advocated by some proponents. In some models, everyone would be tested, or every student or worker.
One enterprising plan was recently detailed in the Atlantic Monthly, based on Harvard epidemiology professor Michael Mina's plan. The plan involves extensive use of low cost/high volume rapid tests in schools and workplaces. Testing in this scenario would be done in great numbers and performed daily.
Likely a more moderate practice continues -- some schools, some workplaces engage in this kind of testing, with industry-based and regional variances.
The attractiveness of this is seen in the South Korea example. The nation is a different governmental system than the U.S., but also a model for a testing protocol that would involve test volume increases. A new study indicates that point-of-care testing played an important role in reducing the spread of SARS-CoV-2 there compared to the U.S., which has experienced 47 times the number of cases and almost 80 times the number of deaths. South Korea's response to the COVID-19 pandemic has been widely lauded -- and is becoming heavily studied.
If COVID-19 vaccines do provide some decline in the overwhelming demand for testing, perhaps the laboratory industry could use it. Even in the fall of 2020, there are capacity limitations, questions about testing accuracy, and challenges with sample collection. But creative solutions have been emerging at labs to help ease the load during a difficult time.
Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group.
Disclosure: LabPulse.com is a sister company of Kalorama Information.