Seegene Inc. (KQ096530), a leading South Korean firm specializing in PCR molecular diagnostics, has announced the development of new PCR test assays addressing the recent global resurgence of mpox. This follows the World Health Organization’s (WHO) recent reclassification of the mpox outbreak as a public health emergency of international concern (PHEIC).

The newly introduced assays, Novaplex™ MPXV/OPXV Assay (RUO) and Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO), are designed for research use only. The Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is particularly notable for its ability to detect mpox alongside other major pathogens causing sexually transmitted infections (STIs).

In 2022, Seegene developed the Novaplex MPXV (RUO) assay using its advanced Seegene Digitalized Development System (SGDDS). This system is part of Seegene’s strategy to rapidly develop and deploy diagnostic assays.

Seegene’s Executive Vice-President and Chief Global Sales and Marketing Officer, Daniel Shin, emphasized the company’s commitment to collaborating with global governments to meet market needs for effective assays.

The rise in mpox cases, originally an endemic in Africa, now poses a global threat, prompting calls for improved access to diagnostic tools in developing countries. Seegene’s latest assays aim to help control the spread of mpox and further its mission of a “world free from all diseases.”

The Novaplex™ MPXV/OPXV Assay (RUO) targets Orthopox-viruses, including Clades 1 and 2 of the mpox virus, enabling early detection and differentiation of the virus, which has a lengthy incubation period of up to 21 days. The Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) detects both Clade 1 and Clade 2, and provides insights into the presence of Clade 1 if Clade 2 is not detected. This assay also covers HSV types 1 and 2, as well as varicella-zoster virus (VZV), using multiplex PCR technology for comprehensive testing.

Both assays incorporate dual internal controls within the same tube to ensure sample integrity and verify the accuracy of results.

Mpox, transmitted between animals and humans and between humans, is marked by pustular or vesicular rashes on various body parts. The WHO declared mpox a PHEIC in July 2022 due to its international spread, though the status was lifted in May 2023 as cases declined. The recent resurgence, driven by the Clade 1 strain, led to the reclassification of mpox as a PHEIC on August 14, 2024. The Clade 1b variant, more transmissible and deadly, has been reported outside Africa, including in Sweden, Pakistan, the Philippines, and Thailand.

With over 23 years of expertise in multiplex PCR technologies, Seegene has previously demonstrated its capabilities by providing more than 340 million COVID-19 tests to over 100 countries. The company’s unique multiplex PCR technology allows simultaneous testing for up to 14 pathogens in a single tube, offering detailed quantitative results.