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Diagnostics Point of care testing, Screening and monitoring, Microbiology and immunology

How to Avert the Next Pandemic

Pandemic preparedness requires long-term investments in disease surveillance, diagnostics, therapeutics, and vaccine development. Yet despite repeated warnings from virologists, microbiologists, epidemiologists, and other public health stakeholders, disease surveillance and diagnostics have been underfunded for decades. Our inability to stop the spread of SARS-CoV-2 has largely been due to the lack of sufficient surveillance and diagnostic infrastructure – including better point-of-care testing.

Arguably, our failure to adequately prepare for a novel pathogen has resulted in the COVID-19 pandemic, which, at the time of publishing, has claimed over 605,000 lives and caused 2.3 million hospitalizations in the US alone (1). We expect similar threats to emerge in the future – so what should we be doing differently to better prepare and prevent a repeat catastrophe?

Pandemic preparedness
Improving response times to new and emerging diseases requires a quantum leap – and the only way for the US to get there is to implement federal policy changes and provide financial incentives that encourage vendors to develop new technologies to close the gap. Crucially, it must support the widespread adoption of point-of-care molecular tests capable of open-access multiplex testing.

Although vaccines are vital for reducing deaths, they do nothing to avert a pandemic caused by a new pathogen. Preventing a small outbreak from escalating into a pandemic requires the widespread adoption of rapid point-of-care testing solutions that can be quickly configured to detect new threats.

Open-access testing
We need open-access technology because we don’t know the identity of the next pathogen capable of causing millions of deaths worldwide. It could be another coronavirus variant – such as the original SARS virus or the Middle East Respiratory Syndrome virus – but it might also be an avian influenza strain or something similar to Ebola. Prior to SARS-CoV-2, avian influenza was regarded as the greatest threat to humanity, largely due to the 1918 influenza pandemic – which caused 20 to 50 million deaths worldwide – and because subtypes H5, H7, and H9 have previously taken human lives (2,3).

The need is clear: to better prepare for the next pandemic, every hospital and clinic should have open-access systems.

Open-access PCR machines are microfluidic by nature and draw test reagents from bulk reservoirs. Ideally, the bulk reservoirs hold sufficient real-time PCR chemistry to process many samples before reagent replenishment becomes necessary. PCR is considered a gold standard chemistry and is manufactured globally by vendors who supply the necessary reagents to all laboratories performing molecular analysis. The chemistry can be synthesized quickly at scale and shipped at room temperature to any location – permitting new tests to be shipped to clinical facilities within one to two weeks of initial pathogen sequencing. The fact that multiple vendors can support manufacturing allows for a lightning-fast response time when providing new tests to clinics. Compare this with the manufacturers of FDA-authorized closed-access systems, which took approximately eight weeks to supply new tests for SARS-CoV-2. This slow response time was certainly influenced by the individual manufacturing plants that make these specialized cartridges – plants that already had limited manufacturing abilities.

The need is clear: to better prepare for the next pandemic, every hospital and clinic should have open-access systems – and they should be used daily for standard pathogen detection. In the event of a novel threat, new tests could be quickly synthesized and delivered to these point-of-care settings, in which rapid identification of infected individuals will greatly improve our chances for successful containment. Solely relying on closed-access systems gives us almost no chance due to the weeks of difference in deployment time – allowing a novel pathogen to infect possibly thousands more victims.

Multiplex testing
Open-access is not the only feature needed for successful containment – it’s also critical to return an informative result when testing symptomatic individuals. Single-plex tests that look for the presence of a single pathogen often return negative results when, in fact, multiple pathogens can be responsible for a similar set of symptoms. Negative results can leave healthcare professionals wondering: is the result a false negative for the deadly pathogen? Or is it a true negative for the tested pathogen, but the patient is infected with another microbe?

Multiplex tests that screen for the ‘usual suspects’ boost the confidence of both the healthcare provider and the patient.

Negative results can be significantly reduced by using multiplex tests that screen for the most likely pathogens causing a set of symptoms. There are around 10 respiratory pathogens that cause early symptoms similar to influenza. Multiplex tests that screen for the “usual suspects” boost the confidence of both the healthcare provider and the patient, who knows what is causing their illness – making them more likely to adhere to quarantine rules or other appropriate protocols for a less dangerous pathogen.

For proper surveillance of emerging pathogens, a negative multiplex test on a seriously ill individual should always be sequenced to determine the true cause of the symptoms. However, sequencing is slow, expensive, and can only be carried out in reference laboratories – therefore not a viable point-of-care solution. That said, sequencing is vital to the characterization of new pathogens so that new PCR tests can be quickly developed, manufactured, and deployed to clinics and hospitals that operate fast, accurate, affordable, and easy-to-use automated systems.

Another area in need of meaningful change is test reimbursement for multiplex testing. The Centers for Medicare and Medicaid Services (CMS) can increase usage of multiplex PCR tests by enacting modest changes to current CMS policies. The government could also provide economic incentives to spark innovation surrounding open-access testing – motivating more vendors to work toward commercializing this vital technology.

Looking forward
Only the federal government has the infrastructure, money, and resources to implement meaningful pandemic prevention. During COVID-19, the government has (rightly) spent billions on testing and vaccines; however, these investments do not address the lack of open-access multiplex PCR testing solutions for point-of-care facilities. Therefore, we remain vulnerable to the next pathogen capable of causing a pandemic. The federal government is not yet familiar with the benefits of open-access technology, given that it has only recently become commercially available and is still not available for FDA-authorized clinical testing in humans. With further education and awareness, though, the US government and public health professionals will implement improved testing strategies to better protect humanity’s future.

Pandemics do not need to be endured. They can be prevented – but, unless substantial changes are made, COVID-19 will not be the last. We need decisive federal action to modernize our disease surveillance capabilities to combat this constant microbial threat. The government must incentivize diagnostic companies to develop open-access, multiplexed systems for point-of-care settings and mandate automated reporting for all test results – ultimately improving real-time disease monitoring. On top of that, the CDC and FDA must “stress test” surveillance infrastructure to spot weaknesses that need to be addressed to improve our chances of containing future novel pathogens. With omnipresent, automated, open-access, multiplexed test solutions for the point-of-care, we may stand a chance at preventing the next deadly pandemic.

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  1. Centers for Disease Control and Prevention (2021). Available at: https://bit.ly/3wF6gB7.
  2. WHO, “Pandemic Influenza Risk Management: WHO Interim Guidance” (2013). Available at: https://bit.ly/3vA4UaK.
  3. CDC, “Influenza Type A Viruses” (2017). Available at: https://bit.ly/3wEJs4v.

About the Author

Jack Regan

CEO and Founder of LexaGene, Beverly, Massachusetts, USA.

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