Seegene USA wins FDA emergency use authorization for multiplex skin ulcer virus diagnostic

Seegene, a global molecular diagnostics company, announced Tuesday that its US subsidiary Seegene USA has received emergency use authorization (EUA) from the FDA for its multiplex molecular diagnostic reagent, the Allplex™ HSV-1&2/VZV/MPXV Assay.

The newly authorized product is a real-time syndromic PCR assay capable of simultaneously detecting and differentiating viral pathogens that cause blistering or ulcerative lesions on the skin and mucous membranes — all in a single test.

Individual diagnostic kits for herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), varicella-zoster virus (VZV) and mpox virus (MPXV) have long existed. This marks the first time the FDA has authorized an integrated diagnostic reagent that can distinguish all three viruses — which share similar clinical symptoms — in a single test.

Because skin lesions are difficult to differentiate by appearance alone, clinicians who rely on single-pathogen tests risk missing co-infections or misidentifying the causative virus. Research presented at the 2024 Clinical Virology Symposium found that when 966 samples that had tested negative on single-pathogen tests were retested using multiplex PCR, 54 previously undetected HSV, VZV or MPXV infections were identified.

The assay also detects both mpox Clade 1 and Clade 2 while separately identifying Clade 2, providing information useful for outbreak response and patient management. Seegene USA developed the product entirely in-house using the company's proprietary syndromic PCR technologies — DPO™, TOCE™ and MuDT™ — along with its digital automated development platform, SGDDS.

"This emergency use authorization is an important milestone in bringing Seegene's syndromic PCR technology to the US market in earnest," said Kim Jun-beom, head of Seegene USA. "We have laid the groundwork for developing locally tailored diagnostic products that meet the needs of clinical laboratories and public health agencies in the United States." Seegene said it plans to build on this achievement to continue expanding its technology-sharing program globally, under which it shares diagnostic technology with partner companies in various countries.