Seegene Develops mpox PCR Test Assays following the WHO Global Health Emergency Declaration

– Develops Novaplex^TMMPXV/OPXV Assay and Novaplex^TM HSV-1&2/VZV/MPXV Assay

– Designed to detect four viruses at once using multiplex PCR technology

– Utilize dual internal controls to ensure highly reliable test results

– Pledges to supply assays meeting the needs of respective countries

SEOUL, South Korea, Aug. 26, 2024 /PRNewswire/ — Seegene Inc. (KQ096530), a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today that it has developed its PCR test assays in response to the public health emergency of international concern (PHEIC) declared by the World Health Organization’s (WHO) on the global spread of mpox.

Seegene develops mpox PCR test assays: Novaplex™ MPXV/OPXV Assay (RUO) and Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO)

The products, which are intended for research use only (RUO), include Novaplex™ MPXV/OPXV Assay (RUO) and Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO). In particular, Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is designed to detect four viruses including mpox virus and other key STI-causing pathogens.

Seegene previously developed Novaplex MPXV (RUO) in 2022 using its advanced Seegene Digitalized Development System (SGDDS), which was developed based on Seegene’s expertise to rapidly create and deploy new assays.

“We will closely collaborate with governments around the world that need assays and plan to supply them with products meeting the needs of their respective markets.” said Daniel Shin, Executive Vice-President and Chief Global Sales and Marketing Officer at Seegene.

There are growing calls to ensure access to medicines for developing countries as mpox, once an endemic disease in Africa, poses a global threat. Seegene’s development of assays aims to curb the global outbreak of mpox and advance its vision of a “world free from all diseases.”

About Novaplex^TM MPXV/OPXV Assay (RUO) and Novaplex^TM HSV-1&2/VZV/MPXV Assay (RUO)

Novaplex^TM MPXV/OPXV Assay (RUO) is designed to detect pathogens caused by Orthopox-viruses, including Clades 1 and 2 of the mpox virus. It enables early differentiation of mpox, which has a long incubation period of up to 21 days.

Novaplex^TM HSV-1&2/VZV/MPXV Assay (RUO) is designed to detect Clade 1 and Clade 2 of the mpox virus, while also distinguishing between Clade 2 of the mpox virus. If the test results are negative for Clade 2, researchers can infer the presence of Clade 1. This assay provides reliable test results with broad coverage, detecting type 1 and type 2 of herpes simplex virus (HSV), as well as varicella-zoster virus (VZV) that exhibit symptoms similar to the mpox virus using the multiplex PCR testing.

Both assays feature dual internal controls (Endogenous Internal Control, Exogenous Internal Control) within the same tube. These controls validate the integrity of the sample and verify the entire testing process, ensuring highly reliable results.

About the virus

Mpox is a viral disease transmitted from animals to humans, as well as between humans. The main symptom is pustular or vesicular rash, which can appear on the face, mouth, hands, feet, chest, and around the anal and genital areas.

In July 2022, the WHO declared mpox a PHEIC over the international outbreak of the mpox. The emergency status was removed in May 2023 as cases declined and progress was made in controlling a global outbreak. However, the swift spread of the virulent strain of the mpox virus across Africa since September 2023 triggered the WHO to declare it once again as a PHEIC on August 14.

The recent surge in mpox cases is driven by Clade 1. Unlike Clade 2, which was prevalent in 2022, Clade 1 has been reported to have a mortality rate of up to 10% in past outbreaks. The current outbreak is driven by Clade 1b, a variant that is more transmissible and lethal than previous strains.

On August 15, a case of mutated mpox was confirmed in Sweden, raising concerns about the spread of the variant virus in Europe. So far, cases of the mutated mpox that have been reported outside of Africa include Pakistan, the Philippines, and Thailand, signaling a global outbreak.

For more information about our products, please contact our marketing team via email at communication@seegene.com.

About Seegene

Seegene has 23 years of dedicated R&D, manufacturing, and business experience around multiplex PCR technologies, which was highlighted during the COVID-19 pandemic when it provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene’s unique multiplex PCR technologies is the ability to simultaneously test up to 14 pathogens in a single tube and provide quantitative results.