One-stop shop for multi-pathogen PCR testing is disease-detection game changer

During the COVID-19 pandemic, a staggering 340 million tests for the virus were supplied across the world by a company based in South Korea that specializes in so-called syndromic real-time polymerase chain reaction (PCR) testing solutions.

Seegene now has global aspirations that exceed this remarkable feat, including developing and interlacing state-of-the-art PCR technologies that can identify up to 15 pathogens with quantitative information in a single tube and developing a platform to exponentially increase the number of diseases able to be tested on a single system, the Seegene OneSystem^TM.

Overcoming hurdles

Growing a molecular diagnostics company in South Korea isn’t easy, as Seegene’s founder and CEO, Jong-Yoon Chun, notes. “There are three main challenges: language, limited human resources, and a low domestic demand — the South Korean market represents only about 1% of global demand,” he says.

But Chun, who endured tuberculosis as a child and had his education disrupted for six years while he recovered, views challenges as opportunities for growth. “I’ve learnt one lesson while growing the company,” says Chun. “Difficult issues often come up, but while they can be painful to deal with at the time, they offer precious opportunities to grow and improve.”

This outlook has served him well, and Seegene has gone on to develop formidable technologies in the area of molecular diagnostics.

The current state of PCR

As the COVID-19 pandemic brought to the world’s attention, PCR is a powerful technology for detecting minuscule amounts of a biological material in a sample. It takes tiny snippets of DNA from a target within a sample and generates millions or billions of copies making it detectable. This allows the early detection of asymptomatic patients. In addition to detecting pathogens and biomarkers for diagnoses, PCR can be used for biological research, agriculture, veterinary science, forensics, and public health surveillance.

But despite the exciting potential of PCR for many fields, the current system underpinning commercial tests can be unfeasible, Chun contends. PCR systems are expensive, so most manufacturers rent them out to hospitals and labs. They subsidize the cost of rental by charging a margin on assays used for tests.

However, since each manufacturer tends to have its own area of specialization, multiple systems are needed to screen for different types of diseases, pushing up the cost and space requirements for hospitals.

Furthermore, when PCR manufacturers update their systems, they have to create new composition analysis libraries known as assays, meaning that the diversity of diseases covered by these libraries expand very little with time.

Under these circumstances, the current PCR testing isn’t viable for smaller clinics and hospitals.

A formidable advantage

Chun and his colleagues at Seegene have a vision to reform the area, and the first step was to develop a significant technological advantage.

Most PCR tests identify only a few pathogens at a time, so if you receive a negative result for a COVID-19 test, you need to take multiple tests to see if you have other respiratory viruses. In contrast, Seegene’s syndromic PCR technology eliminates the need for multiple testing with the ability to test up to 15 pathogens with quantitative information in a single tube.

This allows doctors to do syndromic testing — testing for a range of pathogens that cause similar symptoms. So, for example, you could test for a wide range of respiratory pathogens, including various variants of COVID-19 virus, influenza virus, respiratory syncytial virus, and other pathogenic viruses in a single test. The test also allows users to determine the amount of each pathogen that is present.

“The common understanding of PCR is a single analyte in one channel,” says Chun “But our technology is multiple analytes in one channel. Such multiplexity can be maximized when multiple channels are utilized. That’s a game changer.”

Seegene has also developed a module-based full automated system that can conduct tests for any pathogens. This approach will accelerate the development of new assays to be incorporated.

An audacious challenge

The usual path for a molecular diagnostics company would be to exploit this technological advantage while it is covered by patents. But Chun has a radically different vision — share the proprietary technologies, making them freely available to research partners around the world. These partners will then develop assays themselves and can share them with the community via Seegene’s platform, with Seegene taking a modest slice of the profit. Chun likens the approach to apps on Apple’s App Store: Apple provides the platform and then anyone can contribute their own app to the ecosystem, adding value to all users.

If this innovative move pays off, it will democratize the development, application and use of PCR assays, exponentially increasing the number of diseases that can be tested, says Chun. It will also help meet local demands and harness local resources. This is critical because there is little financial incentive for large molecular diagnostic companies to develop assays that are in demand only in specific regions.

All this will drive the price for PCR testing down, Chun predicts. “One misconception about PCR is that it’s inherently expensive,” Chun says. “I don’t believe that’s true. I think within a decade a test price could be affordable for anyone.”

For Chun, the possibilities are tantalizing. “This could transform diagnosis. For example, in the area of cancer, it could make it possible to detect cancer at very early stages, before symptoms start to show and when treatments can make a real difference. Our ultimate goal is that everyone, regardless of location or economic status, would have the accessibility to this new diagnosis system.”

Implementing the vision

Seegene is negotiating with partners in countries all around the world and has already signed partnership contracts with companies in Israel and Spain.

In addition, in September 2023, it will launch an initiative to recruit researchers to test the idea. In conjunction with Springer Nature, Seegene will launch the Open Innovation Program that will provide global scientists and experts with the opportunity to participate in syndromic PCR assay development.

These are just the first steps in implementing Chun’s vision. He ultimately dreams of a world that is much less vulnerable to the threats of disease and pandemics, linked to the ability to cheaply, rapidly, and precisely diagnose conditions using PCR. “In countries around the world, health budgets are coming under intense pressure as people live longer,” Chun says. “But diagnostics could be a way of relieving this pressure, reducing disease burdens in the future.”

But what drives Chun most is the potential contribution Seegene’s technology can make to lives. “I always think business must primarily contribute to society, with less weight on profit or personal achievement.”