KB News Desk
Seegene said Tuesday that its US subsidiary has received emergency use authorization from the US Food and Drug Administration for a molecular diagnostic test that can simultaneously detect four viruses associated with similar skin and mucosal lesions.
The Allplex HSV-1&2/VZV/MPXV Assay is a syndromic real-time polymerase chain reaction test developed by Seegene USA. It detects herpes simplex virus types 1 and 2, varicella-zoster virus and the virus that causes mpox in a single test.
The company said the test addresses the limitations of conventional single-target diagnostics by enabling clinicians to rapidly distinguish among viruses with overlapping clinical symptoms, improving diagnostic accuracy and reducing the risk of missed infections.
According to a study presented at the 2024 Clinical Virology Symposium, researchers reanalyzed 966 samples that had tested negative using single-target assays with multiplex PCR testing. They detected previously unidentified HSV, VZV and MPXV infections in 54 cases, highlighting the potential for false negatives when testing for only one pathogen.
Seegene said its assay was the first FDA-authorized product under an EUA to detect both MPXV clades I and II while separately identifying clade II, providing clinically relevant information for patient management and infection control.
The authorization expands Seegene USA’s locally developed syndromic PCR portfolio in the United States. It also marks a milestone for the company’s technology-sharing initiative, which supports regional partners in developing and manufacturing diagnostic products tailored to local healthcare needs.
“EUA represents an important step in bringing Seegene’s globally proven syndromic PCR technology to the US market,” said Kim Jun-bum, head of Seegene USA.
He added that it had established a foundation for developing molecular diagnostics tailored to the needs of US clinical laboratories and public health agencies.
