[Edaily Reporter NA EUN-KYUNG ] The U.S. will end the Emergency Use Authorization (EUA) system for diagnostic kits—which was temporarily permitted during the COVID-19 pandemic—at the end of this year. Going forward, the U.S. COVID-19 diagnostic market is expected to be restructured around products with full regulatory approval. Among South Korean diagnostic companies that entered the U.S. market during the pandemic under the EUA, reactions are mixed depending on whether they will transition to full regulatory approval.

According to the pharmaceutical and biotech industry on the 27th, the U.S. Department of Health and Human Services (HHS) announced on the 29th of last month that it would terminate the EUA declaration for medical devices—including COVID-19 in vitro diagnostic devices and personal respiratory protective equipment—on December 26. This decision was based on the assessment that demand for COVID-19 diagnostics has significantly decreased and that, with more than 50 testing products having received full marketing authorization, there is little need to maintain the emergency authorization system.

Products supplied to the U.S. prior to the termination of the EUA will not be recalled and may be used until their expiration dates. However, to supply new products after the termination, manufacturers must obtain formal approval from the U.S. Food and Drug Administration (FDA) or comply with a separate transition policy.

U.S. Respiratory Diagnostics Market Reorganizing Around Combo Kits The

COVID-19

diagnostics market

itself is shrinking rapidly as the pandemic-driven boom comes to an end. However, since COVID-19 has not completely disappeared but has established itself as a respiratory infectious disease that recurs alongside the flu and respiratory syncytial virus (RSV), the nature of diagnostic demand is changing.

Global market research firm Grand View Research forecasts that the market for infectious respiratory disease diagnostics will grow at a compound annual growth rate (CAGR) of 2.9%, expanding from $12.6 billion (approximately 18.6 trillion won) in 2025 to $15.7 billion (approximately 23.2 trillion won) in 2033. While explosive demand similar to that seen during the pandemic is unlikely, analysts predict the market will continue to grow at a moderate pace, driven by testing infrastructure that has expanded beyond pre-COVID-19 levels and the demand for simultaneous diagnosis of respiratory infectious diseases.

Consequently, diagnostic companies that previously held Emergency Use Authorization (EUA)-approved products are shifting their business focus toward combo products—which test for COVID-19, influenza, and other conditions using a single sample—rather than simply converting their standalone COVID-19 products to full regulatory approval. This development reflects the market trend foreshadowed in early 2021 by Robert Ford, CEO of Abbott, who stated, “When patients with a fever visit a hospital, they will want to know at once whether it’s the flu or COVID-19,” predicting a shift toward the integrated respiratory diagnostics market rather than standalone COVID-19 testing.

Among South Korean companies that received Emergency Use Authorization (EUA) for COVID-19 diagnostic kits in the U.S. are Seegene Inc.(096530), SD Biosensor(137310)(SD Biosensor), HUMASIS CO., LTD.(205470), OSANG HEALTHCARE CO.,LTD(036220), Precision Biosensor Inc.(335810), and Access Bio, Inc.(950130). According to our reporting, only Precision Biosensor Inc., Access Bio, Inc., and OSANG HEALTHCARE CO.,LTD have successfully converted their COVID-19 or COVID-19/influenza diagnostic products to full regulatory approval.

Precision Biosensor Inc.’s U.S. subsidiary, NanoDetect, has secured FDA 510(k) clearance for four types of respiratory diagnostic products, including COVID-19, respiratory syncytial virus (RSV), a COVID-19/influenza combo test, and influenza A/B. Starting with COVID-19 and RSV products in 2024, the company received approval for the COVID-19/influenza combo test last year and for the influenza A/B product in January of this year. The influenza product also obtained “CLIA Waived” approval, allowing it to be used outside of specialized laboratories.

Precision Biosensor Inc. official stated, “With a full lineup of respiratory products, we can sell our own brand through small local distributors and supply private-label products to major companies with North American and global distribution networks, such as Sekisui,” adding, “This offers the advantage of securing stable revenue by diversifying our sales channels.”

Access Bio, Inc., a mid-sized pharmaceutical company acquired by PharmGen Science(004720)in 2019, was a prime beneficiary of the U.S. Emergency Use Authorization (EUA) policy. Prior to the COVID-19 pandemic, it was a small-to-medium-sized diagnostics company focused on malaria diagnostic kits, but during the pandemic in 2021, it recorded revenue of $441.37 million (approximately 505.1 billion won at the exchange rate at the time) and operating profit of $227.3 million (approximately 260.1 billion won), marking a dramatic expansion in scale compared to pre-pandemic levels. During this period, Access Bio, Inc. expanded its sales reach in the U.S. by securing successive EMERDS for antibody tests, professional-use antigen tests, and self-test products.

As the expiration of its EMUs approached, Access Bio, Inc. adopted a strategy to rapidly transition to a formal approval system rather than relying on pandemic-driven demand. Following FDA approval of its COVID-19/flu combo self-test product in August of last year, the company secured approval for its professional-use product this past May. Consequently, the company has been able to expand its sales channels beyond the self-test market to professional healthcare settings such as urgent care centers, private practices, and clinics.

An Access Bio, Inc. official stated, “We plan to increase the supply of professional-use products primarily through U.S. healthcare institutions and specialized distribution networks, while pursuing entry into major retail distribution channels for self-test products,” adding, “We are diversifying our sales channels in line with market shifts from standalone COVID-19 tests to COVID-19 and flu combo products.”

Seegene Inc. has no officially approved products… SD is pursuing official approval

As the U.S. market shifts toward “official approval” following the expiration of Emergency Use Authorizations (EUAs), the survival strategies of companies that dominated the market during the pandemic are now being put to the test. While Access Bio, Inc. and Precision Biosensor Inc. have proactively secured FDA full approval for their COVID-19 and flu combo products, SD Biosensor plans to fill the gap in COVID-19 diagnostics by leveraging the existing respiratory diagnostic products and local regulatory approvals and distribution networks held by its U.S. subsidiary, Meridian Bioscience, while pursuing full approval for its own products in the U.S. Seegene Inc., on the other hand, does not yet have any respiratory diagnostic products that have received full approval in the U.S.

SD Biosensor is the South Korean diagnostic company that benefited the most from the pandemic boom. This is because, during the pandemic, it supplied its in-house developed COVID-19 diagnostic products to the U.S. through Roche’s distribution network. Driven by sales of its COVID-19 rapid antigen test kits, SD Biosensor recorded revenue of 2.93 trillion won and operating profit of 1.3877 trillion won in 2021.

Although SD Biosensor does not yet have any officially approved COVID-19 diagnostic products, its U.S. subsidiary, Meridian, holds full FDA approval for rapid diagnostic products for influenza and RSV; therefore, the company maintains that the impact of the EUA’s expiration will be limited. The company is currently working to obtain full FDA approval by transitioning its “Standard M10” point-of-care molecular diagnostic device—which offers simultaneous testing for influenza, RSV, and COVID-19—as well as its Group A Streptococcus product, to the Meridian brand.

An SD Biosensor official explained, “The expiration of the EUA marks a process in which the U.S. market is realigning to focus on products with full FDA approval,” adding, “We will leverage Meridian’s regulatory capabilities and local distribution network to expand synergies between our rapid diagnostic products and point-of-care molecular diagnostic product lines.”

In contrast, Seegene Inc. currently has no COVID-19, influenza, or RSV diagnostic products with full approval for sale in the U.S. While Seegene Inc. is strengthening its local development foundation through its U.S. subsidiary, Seegene USA, and technology-sharing initiatives, it has not disclosed whether it plans to pursue regulatory approval for individual respiratory products or the timeline for such efforts. Since there are no confirmed products to continue sales immediately following the expiration of the EUA, it appears that re-entering the U.S. market will take some time.

When asked about Seegene Inc.’s strategy for respiratory diagnostic kits in the U.S. market, a Seegene Inc. official replied, “We view the U.S. as one of our key global markets and are continuously pursuing product development and regulatory approval strategies tailored to local demand and the regulatory environment.” The official added, “Centered on Seegene Inc. USA, we are strengthening our capabilities to develop diagnostic products needed in the U.S. market, and we will expand opportunities to enter the U.S. market in various infectious disease areas, including respiratory diseases.”