Seegene
Seegene is a South Korean molecular-diagnostics company specializing in multiplex in vitro diagnostic assays.
Last updated August 31, 2026
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History
Seegene was established in South Korea in 2000 as a developer and manufacturer of in vitro diagnostic products. From its early development, the company concentrated on molecular diagnostics, particularly assays based on nucleic-acid amplification and the simultaneous detection of multiple targets. This specialization distinguished Seegene from companies focused primarily on conventional clinical chemistry, imaging, or single-analyte testing. The company built its technology platform around several proprietary methods. Dual Priming Oligonucleotide technology was developed to support selective amplification of target sequences. Tagging Oligonucleotide Cleavage and Extension was used in assay design and signal interpretation, while Multiple Detection Temperatures enabled the analysis of several targets within a multiplex reaction. Seegene also developed GeneFishing for the investigation of differentially expressed genes and DNA Walking for locating unknown sequences adjacent to known DNA regions. These technologies supported a product strategy centered on panels rather than isolated tests. Seegene expanded its clinical product range into respiratory disease, sexually transmitted infections, sepsis, and other infectious-disease categories. Its international development included subsidiaries or operations in North America, Europe, Latin America, and the Middle East. In September 2010, the company raised approximately US$16.6 million through an initial public offering and listed on KOSDAQ, the market operated by the Korea Exchange for many Korean technology and growth companies. The company’s most consequential period began in January 2020, when reports of a novel coronavirus emerged and viral genetic information was made available publicly. Seegene used its assay-development capabilities and artificial-intelligence-assisted design processes to begin developing a diagnostic test. It produced a real-time PCR assay on February 3, 2020. Named the Allplex 2019-nCoV Assay, the test was designed to identify three SARS-CoV-2 targets—the E, RdRP, and N genes—in a single reaction tube. This multiplex design was intended to support accurate, scalable testing and compatibility with automated laboratory workflows. South Korea’s Ministry of Food and Drug Safety granted emergency use authorization on February 12, 2020. As the pandemic accelerated, Seegene redirected manufacturing resources from approximately 60 other products toward COVID-19 testing and reported a production capacity of up to 100,000 tests per day. The company’s assay later received emergency use authorization from the U.S. FDA in April 2020. Seegene reported that more than 10 million tests had been sold in over 60 countries by that point. The pandemic led to exceptional commercial growth and made the company one of the most visible Korean diagnostic manufacturers during 2020. In early 2021, Seegene announced the Allplex SARS-CoV-2 Variants I Assay. Unlike a test focused only on detecting infection, the product was designed to screen for several mutations associated with emerging viral variants while testing for the virus in the same reaction. Seegene stated that it scaled production to 300,000 variant-test kits per month, a capacity described as sufficient to test 30 million people, and distributed the tests to approximately 20 countries. The company also faced regulatory scrutiny. In February 2021, South Korea’s Securities and Futures Commission disciplined Seegene over accounting errors and deficiencies dating from the company’s earlier years. Seegene said that it had acknowledged and reconciled the matters in 2019 and had changed its accounting and management systems. The episode became a notable governance issue in the company’s public history. Seegene continues to operate as an international molecular-diagnostics company. Its business remains focused on multiplex assays and related laboratory technologies for infectious-disease detection, with a geographic structure extending beyond South Korea through operations in the United States, Canada, Germany, Italy, Mexico, Brazil, and the Middle East.
- 2021
COVID-19 variant assay announced
[1]Seegene announces the Allplex SARS-CoV-2 Variants I Assay for combined infection detection and mutation screening.
- 2020
Development of the Allplex 2019-nCoV Assay
[1]Following the release of SARS-CoV-2 genetic information, Seegene develops a multiplex real-time PCR assay targeting three viral genes.
- 2020
Emergency authorizations for COVID-19 testing
[1]South Korea authorizes the Allplex 2019-nCoV Assay for emergency use in February, followed by U.S. FDA emergency authorization in April.
- 2010
Initial public offering on KOSDAQ
[1]Seegene completes an initial public offering of approximately US$16.6 million and lists on KOSDAQ.
- 2000
Seegene is founded
[1]Seegene is established in South Korea and begins developing in vitro diagnostic and molecular-diagnostics technologies.
Products and positioning
A molecular-diagnostics specialist focused on multiplex, high-throughput laboratory assays that can detect multiple pathogens or genetic targets from a single sample.
Molecular diagnostics
Multiplex molecular diagnostic assays
Seegene’s core product family consists of multiplex assays that detect or quantify several pathogens or genetic targets from one clinical sample. These products are designed for laboratory workflows in which broad pathogen coverage, automation, and efficient use of reagents are important. The company applies DPO, TOCE, and MuDT technologies to assay design and target discrimination. Product applications include respiratory infections, sexually transmitted infections, sepsis-related testing, and other infectious-disease panels.
COVID-19 molecular test · 2020
Allplex 2019-nCoV Assay
A real-time PCR assay developed in early 2020 for detecting SARS-CoV-2. The assay targets the E, RdRP, and N genes in a single reaction tube, allowing laboratories to test multiple viral targets simultaneously. It received emergency use authorization from South Korea’s Ministry of Food and Drug Safety in February 2020 and from the U.S. FDA in April 2020.
COVID-19 variant assay · 2021
Allplex SARS-CoV-2 Variants I Assay
A multiplex assay announced in early 2021 for detecting SARS-CoV-2 infection while screening for multiple mutations associated with viral variants in one reaction. Seegene reported production capacity of approximately 300,000 kits per month and international shipment to about 20 countries.
Controversies
2021
Accounting deficiencies and regulatory discipline
South Korea’s Securities and Futures Commission disciplined Seegene in February 2021 over accounting errors and deficiencies connected with the company’s early years. Seegene stated that it had acknowledged and reconciled the issues in 2019 and had subsequently reformed its accounting and management practices.
Brand decisions
2021
Launch of a multiplex SARS-CoV-2 variant-screening assayProduct launchBackground
The emergence of new SARS-CoV-2 variants increased demand for tests that could provide information beyond a basic positive or negative result.
Action taken
Seegene announced the Allplex SARS-CoV-2 Variants I Assay, designed to detect infection and identify multiple mutations in a single reaction.
Aftermath
Seegene reported scaling capacity to approximately 300,000 kits per month and shipping the product to around 20 countries.
2020
Rapid development of a SARS-CoV-2 assayProduct launchBackground
The emergence of a novel coronavirus and the publication of its genetic sequence created an urgent need for scalable molecular testing.
Action taken
Seegene used its assay-design capabilities to develop the Allplex 2019-nCoV Assay, a real-time PCR test targeting three SARS-CoV-2 genes in one reaction.
Aftermath
The assay received emergency authorizations in South Korea and the United States and was distributed internationally during the pandemic.
2020
Manufacturing capacity redirected to COVID-19 testingStrategyBackground
Demand for coronavirus testing increased sharply as the pandemic accelerated.
Action taken
Seegene reduced production of approximately 60 other assays and redirected resources toward COVID-19 products, reaching reported output of up to 100,000 tests per day.
Aftermath
The company expanded sales to more than 60 countries and became a prominent supplier of pandemic molecular tests.
Recent events
Seegene reports third-quarter 2021 results[3]
Reported:
Seegene announced its third-quarter 2021 financial results, reporting sales revenue of KRW 305.3 billion and operating profit of KRW 128.6 billion.
Seegene launches SARS-CoV-2 variant detection test[4]
Seegene announced the launch of the Allplex SARS-CoV-2 Variants II Assay, a diagnostic test capable of screening six SARS-CoV-2 variants, including Delta and Delta Plus.
Seegene and Bio-Rad sign U.S. diagnostic-products partnership[5]
Reported:
Seegene said it signed a partnership with Bio-Rad for clinical development and commercialization of infectious-disease molecular diagnostic products for the U.S. market, subject to clinical development and FDA approval.
Sources6 sources
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