Seegene Unveils mpox PCR Tests after WHO Health Emergency
Tuesday, August 27, 2024
Seegene announced the development of new PCR test assays in response to the World Health Organization's (WHO) recent declaration of mpox as a public health emergency of international concern (PHEIC).
Mpox is a viral disease transmitted from animals to humans, and between humans. It primarily presents with a pustular or vesicular rash, which may appear on the face, mouth, hands, feet, chest, and around the anal and genital areas.
The Novaplex™ MPXV/OPXV Assay (RUO) is designed to detect Orthopoxvirus-related pathogens, including Clades 1 and 2 of the mpox virus, allowing for early differentiation due to the long incubation period of up to 21 days.
The Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) identifies Clades 1 and 2 of the mpox virus, distinguishing between them. If Clade 2 is not detected, researchers can infer the presence of Clade 1. This assay also reliably detects herpes simplex virus types 1 and 2, as well as varicella-zoster virus, all of which exhibit symptoms similar to mpox.
The newly developed assays, intended for research use only (RUO), include the Novaplex™ MPXV/OPXV Assay (RUO) and the Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO). Notably, the Novaplex™ HSV-1&2/VZV/MPXV Assay (RUO) is designed to detect mpox along with other significant pathogens responsible for sexually transmitted infections (STIs).
In 2022, Seegene utilised its advanced Seegene Digitalized Development System (SGDDS) to create the Novaplex MPXV (RUO). This system leverages Seegene's expertise in rapidly developing and deploying new diagnostic assays.
The global spread of mpox, which was once limited to Africa, has led to increasing demands for accessible treatments, particularly in developing countries. Seegene's assay development is aimed at controlling the mpox outbreak and supporting the company's vision of a "world free from all diseases.
Both assays include dual internal controls (Endogenous Internal Control, Exogenous Internal Control) within the same test tube, ensuring sample integrity and the reliability of the entire testing process.
In July 2022, the WHO declared mpox a PHEIC due to its international outbreak. Although the emergency status was lifted in May 2023 following a decline in cases, the virus’s rapid spread in Africa since September 2023 led to the WHO reinstating the PHEIC status on August 14.
The recent increase in mpox cases is largely due to Clade 1, which differs from the Clade 2 strain prevalent in 2022. Clade 1 has historically shown a mortality rate of up to 10%. The ongoing outbreak involves the more transmissible and lethal Clade 1b variant.
On August 15, Sweden reported a case of mutated mpox, raising concerns about the spread of this variant across Europe. Other cases outside of Africa have been reported in Pakistan, the Philippines, and Thailand, signalling a growing global outbreak.
Source: prnewswire.com
