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A New Diagnostic Era
For more than two decades, the South Korean biotechnology company has concentrated on molecular diagnostics, developing technologies capable of identifying multiple pathogens simultaneously. Now, its ambition is moving beyond individual products toward advancing how PCR testing is used: from tests targeting selected pathogens to comprehensive, patient-focused diagnostics.
“Just making money is not our company’s goal. How we contribute to humanity and make a difference to the world is what matters,” said Founder and CEO Dr. Jong-Yoon Chun. “If it’s something that can be done by others, we are not going to do it, but if it is something that only Seegene can do, then we should pursue it to make the world a better place.”
That philosophy underpins the Global Million Clinical Study (GMCS), an initiative designed to accumulate real-world evidence from one million test cases and assess the clinical utility of comprehensive syndromic PCR testing.
For Seegene, the project represents something larger than another clinical program. “The million clinical study is not simply one project,” said Chun. “We are trying to drive a paradigm shift in molecular diagnostics.”
Evidence at Scale
Supporting a more comprehensive diagnostic approach requires evidence across different populations, healthcare systems and patterns of infectious disease.
GMCS is designed around one million real-world test cases, beginning in South Korea and extending to healthcare institutions worldwide. Rather than changing existing clinical practice, the initiative will accumulate testing data to evaluate the clinical utility of comprehensive syndromic PCR across respiratory, gastrointestinal and reproductive-tract infections.
Testing protocols and reimbursement policies differ between countries, meaning similar conditions can receive different scopes of testing. GMCS aims to build evidence that can inform more consistent disease-specific testing strategies. In many healthcare systems, testing pathways and reimbursement frameworks were established before today’s comprehensive multiplex technologies became widely available. As diagnostic capabilities evolve, GMCS is intended to contribute clinical evidence that can help inform future discussions about how broader diagnostic information and its clinical value should be evaluated.
Early insights generated through STAgora™ helped shape the scientific rationale for GMCS. Seegene’s PCR data analytics and statistics platform examines aggregated real-world testing data, including pathogen prevalence, co-detection and geographic and temporal trends. Those analyses revealed patterns that raised broader questions about what conventional, narrower testing strategies may leave unseen. GMCS is intended to investigate whether those patterns are reproduced across different populations and healthcare systems, and what clinical significance they may carry.
“GMCS is a kind of baseline for PCR tests all over the world,” said Chun. “We want to share our technology, instruments and data platform, and ultimately move toward a world free from all diseases.”
Seeing the Full Picture
Seegene’s analysis of existing real-world testing data provides some of the evidence that helped frame the scientific questions behind that strategy. An analysis of 256,910 real-world respiratory multiplex PCR results in South Korea found that combined virus-and-bacteria testing produced a 96% positivity rate, compared with 87% for virus-only testing and 76% for testing focused on pneumonia-associated bacteria.
More striking was the prevalence of multiple pathogens. Among positive results from comprehensive testing, 82% involved co-detection, suggesting that respiratory infections can present a considerably more complex pathogen landscape than single-target testing reveals. The analysis also found that 78% of virus-positive cases had pneumonia-associated bacterial pathogens detected, while 88% of cases positive for those bacterial pathogens also had viruses detected.
For Seegene, these findings raise clinically important questions rather than provide definitive answers. High levels of co-detection suggest that narrower testing strategies may leave additional potentially relevant information unseen, but the findings alone do not establish that broader testing leads to better clinical outcomes. GMCS is intended to examine the potential clinical relevance of broader diagnostic information, including how it may relate to patient management, treatment decisions, additional testing and infection-control considerations.
“If you look at viruses and bacteria together, you can detect much more,” said Chun. “An important finding is the high level of co-detection. It suggests that when someone presents with a respiratory infection, multiple viruses and bacteria may be detected.”
The opportunity is therefore not simply to detect more targets, but to determine whether the broader information generated through a comprehensive testing strategy can provide meaningful clinical value.
Beyond Respiratory Disease
The same comprehensive approach extends beyond respiratory infections. Seegene’s real-world datasets indicate that broader testing can reveal additional detection patterns across gastrointestinal and reproductive-tract infections, providing a foundation for further investigation across several major disease categories through GMCS.
In gastrointestinal testing, analysis of 105,473 results from children under five in South Korea found a 64% positivity rate when bacterial and viral panels were combined. That compared with 41% for virus-only testing and 38% for bacteria-only testing. Co-detection reached 31% with the combined approach, versus 3% and 5%, respectively, when the panels were considered individually.
A separate analysis of 57,675 HPV28 and STI-12 results across all age groups produced a similar pattern. Combined testing recorded 81% positivity and 71% co-detection, compared with positivity rates of 41% for HPV28 alone and 73% for STI-12 alone.
The broader proposition is straightforward: when high-multiplex syndromic PCR can examine a broader range of clinically relevant targets within a comprehensive workflow, diagnostic information need not remain constrained by historically narrow testing categories.
“Why select only two or four targets when technology can provide more comprehensive information?” said Chun. “The goal is to give the patient the full benefit of the technology.”
From Tests to Intelligence
Comprehensive testing creates another asset beyond individual diagnostic results: data. Seegene’s strategy is to aggregate de-identified testing information and transform millions of otherwise isolated laboratory results into intelligence on pathogen prevalence, co-detection and epidemiological trends.
STAgora™ illustrates how aggregated PCR testing data can be analyzed to generate broader insights. The platform can visualize individual target detection, combinations of pathogens, Ct values and changes in prevalence, while GMCS is intended to build a clinical evidence framework around comprehensive PCR testing by connecting de-identified test results with relevant clinical and epidemiological context. Rather than simply aggregating data, the initiative aims to enable participating researchers to evaluate the clinical utility of broader diagnostic information for patients, laboratories and healthcare systems.
“Laboratories are doing thousands of tests every day, so why use all that data only for one patient?” said Chun. “We should share de-identified test results, aggregate the data and generate new statistical insights.”
GMCS extends that concept into a global clinical evidence framework. By bringing comprehensive PCR test results together with appropriate clinical and epidemiological context across participating institutions, Seegene aims to create an expanding evidence base that can help researchers assess the clinical relevance and utility of broader testing.
Automating the Laboratory
Data is only one side of Seegene’s expansion. CURECA™, its automated PCR workflow platform, is designed to tackle a key constraint in molecular diagnostics: the complexity and labor involved in processing samples from beginning to end.
“Our goal is to automate the PCR workflow from beginning to end,” said Chun. “The system is being designed to reduce the level of specialized manual intervention required in PCR workflows. What we are trying to create is a next-generation approach in diagnostics—with the aim of enabling more continuous operation.”
CURECA’s modular design is intended to make the system attachable, expandable and customizable for different laboratory environments. By integrating preprocessing, nucleic acid extraction, amplification and result processing, including pretreatment of complex specimen types such as stool, urine, blood and sputum, Seegene ultimately aims to reduce manual intervention and move toward more autonomous PCR laboratory operations.
CURECA also reflects Seegene’s effort to accelerate the conventional diagnostic instrument development model. Chun said the platform was developed in roughly a year and a half, combining internal technological direction with external expertise to enhance execution speed and product readiness. The approach reflects Seegene’s broader strategy for advancing molecular diagnostics.
Opening the Innovation Engine
The company’s strategy of integrating its unique high-multiplex chemistry with automation and data platform technology is complemented by an even more unconventional ambition: sharing Seegene’s development capabilities beyond its own laboratories. Rather than relying exclusively on internal R&D, the company wants scientists and organizations in different markets to use its technology and development processes to create diagnostic assays addressing local and global needs.
The rationale is scale. A single company has finite resources, access to samples and specialist knowledge, which limits its reach, while a wider network can draw on expertise across diseases, geographies and scientific disciplines. Seegene sees sharing its technology as a way to multiply development capacity without attempting to build every solution centrally. The vehicle to carry out this strategy is the Seegene Technology Sharing Business.
“One company, no matter how many scientists it has, has limited resources,” said Chun. “If we share the technology, many scientists and organizations around the world can participate in product development. Instead of relying only on our R&D team, we can have R&D teams across many countries working together to address local and global needs.”
The mission of Seegene Technology Sharing Business is to establish local NewCo partnerships with full R&D and manufacturing capabilities in different countries, ultimately building a global consortium for syndromic molecular diagnostic assay development.
For international partners, the model for Seegene Technology Sharing Business combines local scientific knowledge with Seegene’s high-multiplex syndromic PCR technology platform, potentially accelerating new diagnostic development. Seegene has initiated its first wave of NewCo partnerships with established healthcare and diagnostics companies in key international markets, creating a foundation for locally driven diagnostic product development. The partnerships mark concrete steps in expanding Seegene’s technology-sharing model across international markets.
The model could also strengthen the global reach of GMCS. By enabling local scientific and clinical partners to develop assays, generate evidence and address region-specific disease needs, Seegene sees technology sharing as a way to broaden both the scale and geographic relevance of the clinical evidence generated through its global network. In this model, international partners do not operate separately from GMCS; their participation can help extend its geographic diversity and scientific relevance.
Partnership Without Borders
Seegene combines control of its core technology and intellectual property with external expertise in development, production and other specialized areas.
For Chun, collaboration is partly a response to the accelerating pace of technological change. Instead of attempting to internalize every discipline, Seegene can select specialists for different parts of a project, allowing multiple organizations to contribute to a common objective.
“The speed of business is so important nowadays because every year new technology is coming,” said Chun. “It is better to maximize outsourcing and, at the same time, share our technology with the world.”
That openness does not mean relinquishing the company’s technological foundations. Seegene maintains an in-house patent function that Chun considers central to protecting its intellectual property while enabling collaboration. “Our core technology is strongly protected by patents,” he said. “I don’t mind sharing or outsourcing as long as we maintain that protection.”
For potential international partners, the resulting proposition is broad: collaboration can extend across technology sharing, product development, manufacturing expertise and market expansion. Seegene’s model seeks to preserve ownership of its core innovations while using outside capabilities to accelerate their reach.
Prepared for the Next Threat
The value of a distributed diagnostic network becomes particularly clear when viewed through the lens of future outbreaks. COVID-19 demonstrated how quickly testing capacity can become strategically important, but Seegene’s longer-term concern is preparedness for emerging pathogens that may appear in different combinations and locations.
With the origin and characteristics of future outbreaks impossible to predict, Seegene wants diagnostic capabilities that can adapt rapidly across markets.
“Something can come from Korea, America, India, Japan or anywhere else. Nobody knows,” said Chun. “If we share the technology, local scientists could respond more rapidly by developing tests suited to emerging needs, while monitoring what is happening in their own regions.”
That philosophy builds on Seegene’s experience during COVID-19, when demand for molecular testing expanded rapidly worldwide. Its technology-sharing strategy seeks to decentralize some of that response capacity by enabling local scientists to develop assays using a shared digital development platform built around Seegene’s syndromic PCR technology.
For Seegene, preparedness therefore becomes both a healthcare objective and a partnership opportunity. A broader international development network could strengthen local diagnostic development capabilities while creating an ecosystem in which Seegene’s technology supports faster responses to emerging infectious threats.
Five Years Forward
Looking five years ahead, Seegene’s immediate priority is to establish the clinical evidence for comprehensive PCR through GMCS and broaden access through clinical and laboratory networks worldwide. In parallel, the company aims to expand its technology-sharing model, enabling scientific and clinical partners in different regions to develop assays, generate evidence and contribute to a broader international diagnostic network.
Beyond those immediate priorities, Chun also envisions a more forward-looking evolution toward decentralized molecular testing, potentially extending into the home.
“Within five years, comprehensive PCR testing should become much more routine,” said Chun. “The second achievement I expect is technology-sharing across perhaps 20 or 50 countries, so product development is not done by a single company but by many scientists working together.”
Home-based testing represents the most forward-looking element of that vision. Chun envisions future PCR instruments becoming sufficiently accessible that households could eventually monitor infections routinely, including before symptoms emerge.
“Within five years, I think this kind of instrument could be used in households,” he said. “PCR can find what is wrong even without symptoms.”
It remains a vision rather than a current commercial commitment, and Seegene’s more immediate focus remains on generating clinical evidence for comprehensive PCR through GMCS and expanding access through clinical and laboratory networks.
Built for Speed
Seegene’s expansion also reflects characteristics that Chun sees as fundamental to South Korea’s emergence as an innovation economy: intensive commitment to R&D, rapid execution and a willingness to compete internationally despite the limitations of a relatively small domestic market.
These constraints shaped Seegene from its early years. Compared with larger Western markets, Korea offered a smaller commercial base for molecular diagnostics, and specialist talent in the emerging field was harder to find. The response was to compete through technological differentiation and multidisciplinary R&D, integrating expertise in biology with disciplines such as physics, mathematics and statistics.
That approach is reinforced by a Korean business culture Chun associates strongly with speed. “Korean culture invests a huge amount of time,” he said. “The second factor is the speed of business. Korea is always pushing to do things quickly.”
For international investors and partners, Seegene illustrates how concentrated R&D, fast development and global ambition can turn technological specialization into international opportunity.
Investing in Difference
For investors, Seegene’s proposition rests on differentiation. More than two decades focused on PCR diagnostics now underpin a strategy spanning comprehensive testing, automation, data intelligence and distributed assay development.
That specialization creates the foundation for its next stage. GMCS seeks to generate clinical evidence around the clinical utility of comprehensive PCR; STAgora helps identify and analyze real-world testing patterns that can inform scientific questions; CURECA aims to make comprehensive PCR more scalable through a modular platform designed to automate complex laboratory workflows from sample to result; and technology sharing could extend both Seegene’s development capabilities and the geographic reach of evidence generation across an international network. Together, these initiatives represent an attempt to build an ecosystem around molecular diagnostics rather than compete solely through individual assays.
“Our approach is something that cannot easily be copied,” said Chun. “Investors should consider whether this is the right direction. I believe the direction is very clear.”
The opportunity is inseparable from Seegene’s broader philosophy. Commercial growth, in Chun’s view, should follow from solving problems that remain unresolved and making advanced diagnostics more useful and accessible. Seegene’s broader objective is to provide more comprehensive diagnostic information without a proportionate increase in testing cost.
“As long as our direction is right, the company and the business will grow,” he said. “If we can provide something better, why would we not do it?”
