Korea Expands Home Testing to Flu and STDs; Diagnostics Firms Accelerate Growth Plans

Original from: Seoul Economic Daily

Korea's diagnostics industry is buzzing as the Ministry of Food and Drug Safety (MFDS) moves to expand the range of conditions that can be tested with home diagnostic kits to include influenza and sexually transmitted diseases. Market growth expectations are rising as diagnostic kits previously restricted to professional use become available to general consumers. Companies are accelerating development of self-testing kits in response to the policy shift.

According to industry sources on Wednesday, MFDS recently issued an advance notice to expand in-vitro diagnostic medical device categories, allowing consumers to directly purchase and use diagnostic kits for STDs, drugs, and influenza. The plan adds three new categories—influenza, STDs including syphilis, gonorrhea, and chlamydia, and drugs—to the current 10 self-testing items including blood glucose, pregnancy, COVID-19, and HIV tests.

The diagnostics industry has welcomed the move. Expanding self-testing kit categories has been a longstanding industry demand. "Since COVID-19, concerns about the accuracy and technology of self-diagnostic kits have been largely resolved, and we have consistently called for expansion into areas like influenza," an industry official said. "For STDs, there is a significant population reluctant to visit hospitals, making the need for expanded self-testing even greater."

Self-testing for various conditions is already common overseas. HIV self-testing is widely used in the United States, Europe, and China, and the World Health Organization (WHO) recommends expanding self-testing, particularly in regions with limited healthcare access such as Africa.

Consumer benefits are also expected to improve significantly. Influenza testing at hospitals costs 30,000 to 50,000 won ($22 to $37) per test, while self-testing kits can be purchased for 3,000 to 5,000 won. Under current in-vitro diagnostic medical device regulations, influenza self-diagnostic kits are classified as professional-use only, available for purchase only by hospitals and medical device vendors, not the general public. Analysts note that reducing costs and hospital waiting times could contribute to early diagnosis of infectious diseases and prevention of their spread.

Companies are moving quickly. Genbody aims to launch Korea's first HIV self-diagnostic kit this year. "We are currently in the MFDS approval process for our HIV self-diagnostic kit and expect approval as early as June or July," a Genbody official said. "We are accelerating product development in line with MFDS's policy direction to expand self-testing categories." Genbody is pursuing global certifications as it develops self-diagnostic products as a new growth driver. Products including the ConfiSign HIV ST, the ConfiSign HCV ST for hepatitis C, and the ConfiSign HIV/Syphilis Combo ST are undergoing EU In-Vitro Diagnostic Regulation (CE IVDR) and WHO Prequalification (PQ) certification.

Existing professional diagnostic kit companies are also considering entry into the consumer market, confident that their accumulated R&D capabilities from professional kit development can translate to self-diagnostic kits. SD Biosensor (137310.KQ) currently offers COVID-19, pregnancy, and blood glucose self-diagnostic kits, while its syphilis, influenza, and HIV products remain professional-use only. "SD Biosensor has a globally validated diagnostic portfolio for various conditions included in the amendment, such as syphilis and influenza," a company official said. "We are carefully preparing to supply products that meet domestic guidelines, comprehensively considering market environment changes and demand."

HLB Panagene (046210.KQ) is also reviewing market entry through its subsidiary Biosquare. "Leveraging our professional diagnostic kit development capabilities, the technical hurdles for transitioning to self-testing products are not high," a company official said. "We will be able to respond quickly when the market fully opens."

Sugentech (253840.KQ) is also examining potential entry into the business. "We are conducting preliminary reviews of related technology and product development possibilities in line with the policy direction," a Sugentech official said. "We plan to respond quickly based on our technological capabilities as regulations are finalized and approval standards are established, and to proceed step by step with product development that aligns with market and regulatory environment changes."

Seegene (096530.KQ), a molecular diagnostics company specializing in polymerase chain reaction (PCR) testing, said it will "monitor the situation and respond accordingly" regarding business expansion possibilities. "This regulatory relaxation will be a turning point for the full-scale expansion of the self-diagnostic market," an industry official predicted.

Source: Korea Expands Home Testing to Flu and STDs; Diagnostics Firms Accelerate Growth Plans