Why syndromic PCR technology is key to a pandemic-proof world

COVID-19’s danger lay in its invisibility. The SARS-CoV-2 virus is highly contagious and can be passed on by people with light or no symptoms, making it extremely difficult to track and contain.

But one technology more than any other had the ability to render the invisible visible — polymerase chain reaction (PCR) testing. The COVID-19 pandemic demonstrated the power of PCR to quickly and accurately identify pathogens causing infection, even for non-symptomatic cases. This helped to curtail the spread of infection in communities, saving many lives.

It really felt like that PCR’s moment had arrived during the COVID-19 pandemic. However, one molecular diagnostics company in South Korea believes that the full potential of PCR has yet to be unleashed. Seegene — which supplied the world with 340 million PCR tests during the pandemic — has a vision for a world in which pandemics are a thing of the past, with the widespread adoption of a revolutionary PCR technology.

Seegene knows that achieving this ambitious vision will require much more than the efforts of one company, and is implementing bold plans to share their technology globally, which will empower researchers around the world to develop their own assays.

“Our vision is to create a world free of diseases and future pandemics,” says Jong-Yoon Chun, founder and CEO of Seegene, which is based in Seoul. “But we are very conscious that we can’t do it alone — we need the collaboration with companies, scientists, and experts across all fields from around the globe, which is why we plan to share our PCR technology with the world.”

Countering emerging threats

As serious and disruptive as it was, the COVID-19 pandemic may be a precursor of more threats to come. Several developments are making it more likely for existing pathogens to spread and new ones to emerge.

In particular, global warming is likely to have complex and unforeseen effects on the emergence and spread of pathogens. Tropical diseases are likely to extend their domains towards higher latitudes, and environmental stresses such as higher temperatures and humidities can accelerate mutations in microorganisms and increase the threat they pose to human health. A 2022 study in Nature Climate Change found that climate change could aggravate the threat posed by more than half of known human pathogenic diseases¹.

Another threat is the emergence of new pathogens that most people have little or no natural immunity to, such as SARS-CoV-2, which caused COVID-19. There are concerns that global warming will cause people to be exposed not only to new pathogens, but also to ancient ones that have been suspended in ice since prehistoric times.

The thawing of permafrost will liberate ‘time-travelling’ microorganisms which can be easily mutated in a new environment^1,2. The infectious diseases they cause can be highly damaging to ecosystems, not to mention the risks they pose to human health.

Another mechanism by which climate change can contribute to new threats is that, as air temperatures become closer to body temperatures, pathogens may acquire mutations that make them more tolerant to the high temperature of the human body³.

“The expansion of pathogenic microorganisms in response to climate change is a big issue,” says Jae Hyeok Choi, director of Seegene’s Platform Business Department. “For example, Candida auris, a deadly and highly drug-resistant fungal species, is thought to have adapted to higher temperatures of its natural habitats and ultimately gained the ability to infect humans due to global warming³. Another example is the rise of Valley fever incidence in the United States caused by climate change⁴.”

Finally, as natural habitats are increasingly removed to make way for human development, there will be greater contact between people and wildlife, raising the risk that pathogens in wildlife will spill over into human populations with little or no natural immunity.

As was clearly demonstrated by COVID-19, PCR is a powerful tool for rapidly detecting such threats as they emerge. A PCR test for SARS-CoV-2 was developed within a couple of weeks of its genome being sequenced. Seegene believes it will also help diagnose and contain the spread of new pathogens in the community as it did during the COVID-19 pandemic.

“PCR is a critical weapon in our arsenal against emerging threats,” says Jik-Young Park, vice president of Seegene’s Research & Development Department. “Its ability to provide early diagnosis can protect us against new threating mutations and the spread of disease.”

Identifying biomarkers

But the potential of PCR is not restricted to simply detecting infectious pathogens; it can also be used to detect non-communicable diseases such as cancer and genetic diseases by detecting biomarkers in urine, blood and other samples. Increasingly, researchers are discovering new biomarkers that could indicate the presence of diseases in a person, often even before symptoms appear.

Due to its high speed and accuracy, multiplex quantitative PCR (qPCR) is the perfect diagnostic technology for detecting multiple biomarkers. This will help doctors to diagnose conditions in their early stages, while they are much more responsive to treatment. The implications of this for cancer treatment are huge.

“One of the greatest advantages of PCR is that its high sensitivity enables detection of biomarkers at early stages of cancer,” says Chun. “At such early stages, doctors generally have many treatment options at their disposal.”

Choi is also excited about the implications for cancer therapy. “New biomarkers for cancer are being discovered all the time,” he says. “This, combined with PCR, will allow earlier and more specific treatment. For example, cancer therapy will be much more effective when the specific biomarkers on the tumour cells and those environments are identified. When you have this information, you can apply treatment with high precision.”

Going beyond a one-company model

Currently, the molecular diagnostics field is dominated by a few companies that develop a handful of assays each year, obtain approvals from limited number of countries due to complex regulations, and have centralized manufacturing sites. Realizing the full potential of PCR technology will require global cooperation on a scale not seen before in molecular diagnostics, and Seegene believes this can be achieved by sharing its technology through a newly created or developed business model known as OneSystem™.

Under OneSystem™, Seegene will build a global business network by partnering with a representative company from each country to establish a new company that develops its own diagnostic assays, as well as distribute products developed by the network under OneSystem™. This will localize capabilities and expertise necessary to optimize the democratization of PCR technology for each country, while maximize global distribution through the OneSystem™ network.

This technology sharing strategy will exponentially increase the number of new diagnostic products. Coupled with the ability of Seegene’s syndromic qPCR technology to detect up to 15 targets per test, which enables one assay to test for a range of pathogens that cause similar symptoms, this will drive down the cost per test and make PCR much more cost effective.

Since all the tests developed under OneSystem™ can be performed on a single instrument system, the number of instruments needed for hospitals and diagnosis labs will be greatly reduced.

“We want to share our OneSystem™ with companies worldwide,” says Dae-Hoon Lee, head of Research & Development Department of Seegene. “It’s a new business model of sharing our technologies and expertise with collaborators and researchers to maximize the development and utilization of syndromic qPCR.”

Seegene is currently looking for a partner in each country to join this initiative. And the selected partners will then gain access to Seegene’s OneSystem™ (technology, development tools, and business network). Seegene has already signed contracts with a company in Israel, and is in progress with other companies in Europe.

This is an unprecedented initiative. “Our vision is to attempt something radically different,” says Lee. “We want to foster global collaboration through making OneSystem™ available to scientists, experts and partner companies around the world. It will lead to global democratization of PCR in all fields.”

Further into the future

Looking even further into the future, Seegene envisions a world in which PCR tests are incorporated into everyday life, enabling continuous health monitoring of people and animals. Routine testing could alert people of pathogens or diseases before symptoms appear.

“We’re striving to actualize a new business model that involves sharing technology with the aim of making the world more robust against emerging threats,” says Chun. “We strongly believe that companies should embrace a philosophy of contributing to society. Through collaborative efforts, we can eventually realize a world free from all diseases.”