Seegene Expands mpox RUO Product Lineups with Enhanced Detection Assays for Clade 1

• Introduces Novaplex™ MPXV/OPXV plus Assay (RUO) that is designed to detect Clade I, which has higher transmission and mortality rates than Clade II
• Adheres to the WHO issued target product profiles and provides accurate detection of viral strains
• Offers healthcare professionals with a critical tool in their research on the global spread of mpox by supporting international efforts

SEOUL, South Korea, Sept. 9, 2024 /PRNewswire/ -- Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the monkeypox virus variant, Clade Ib, which is currently prevalent in Africa.

The newly introduced Novaplex™ MPXV/OPXV plus Assay (RUO) is designed to detect 3 targets causing mpox disease: non-variola Orthopoxvirus (OPXV) and monkeypox virus (MPXV) with specific confirmation of MPXV Clade I. MPXV Clade I is associated with higher transmission and mortality rates than MPXV Clade II. 

The assay meets the preferred target product profiles (TPPs) issued by the WHO, which guide manufacturers, suppliers, and researchers developing new assays for detection of viruses causing mpox. Additionally, it aligns with the preferred target analyte criteria for distinguishing between Clade I and II.

Seegene has been responding swiftly to the August 2024 global public health emergency (PHEIC) declared by the WHO regarding the mpox outbreak by developing two assays designed to detect mpox virus and announcing plans to supply the products to countries in need.

Among these, Novaplex™ MPXV/OPXV Assay (RUO) is designed to detect MPXV Clade I and Clade II as well as OPXV infections, while Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is designed to simultaneously detect four viruses including MPXV, herpes simplex virus (HSV) Types 1 and 2, and varicella-zoster virus (VZV). These products also comply with TPPs issued by the WHO.

"As the spread of mpox continues unabated, we have developed new RUO assays for detection of viruses causing the mpox to meet the increasing research demand from affected countries. We are committed to actively supporting global efforts to curb the spread of mpox," said Daniel Shin, Executive Vice-President and Chief Global Sales and Marketing Officer at Seegene.

In 2022, Seegene had previously leveraged its proprietary reagent development expertise and automated reagent development system (SGDDS) to create the Novaplex™ MPXV Assay (RUO).

From January 2024 to September 6, 2024, there have been a total of 24,851 suspected cases, 5,549 confirmed cases and 643 deaths reported across the member states in the African Union (AU), according to the Africa Centres for Disease Control and Prevention (Africa CDC). The mpox variant is now spreading beyond African countries including Sweden, Pakistan, the Philippines, Jordan and Thailand.

About Seegene 

Seegene has 23 years of dedicated experience in R&D, manufacturing, and business related to multiplex PCR technologies. This expertise was particularly highlighted during the COVID-19 pandemic when Seegene provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene's multiplex PCR technology is the ability to simultaneously test for 14 pathogens that cause similar symptoms in a single tube and provide quantitative information on the infection profile to correlate with the progression of illness.

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