Herpes Simplex Virus Molecular Test Receives US FDA Clearance

A leading developer of multiplex polymerase chain reaction technology has announced that its herpes simplex virus (HSV) types 1 and 2 assay has been granted 510 (k) market clearance.

The tests are based on its breakthrough technology that allows simultaneous detection and quantification of multiple targets in a single fluorescence channel, without melting curve analysis and the tests are the most comprehensive and cost-effective multiplexed polymerase chain reaction (PCR) molecular assays for infectious disease in the industry.

The US Food and Drug Administration (FDA, Silver Springs, MD, USA) has granted the market clearance for the high multiplex real-time quantitative PCR known as TOCE technology, that enables confirmation of multiple (five or more) target genetic detection and genetic variation. TOCE can implement qualitative test that analyzes multiple clinical samples and quantitative analysis bases on Cyclic Catcher Melting Temperature Analysis (cyclic-CMTA).

The company producing the approved HSV types 1 and 2 assay is Seegene (Seoul, Republic of Korea) that uses the Allplex tests which are based on its breakthrough MuDT technology. This powerful technology is capable of simultaneous quantification and detection/discrimination of multiple targets in a single channel without additional melting curve analysis after amplification step. It satisfies the growing demands for both high multiplexing and quantification in a single assay by overcoming the current technology barrier of “one channel, only one cycle threshold (Ct).” MuDT technology opens a new chapter of PCR-based molecular diagnostics to deliver a more comprehensive and actionable diagnostic information.

Jong-Yoon Chun, PhD, founder, CTO and CEO of Seegene, said, “This is an important milestone in support of our planned entry into the USA, the largest molecular diagnostic market in the world. After more than 10 years of extensive efforts to continually develop and commercialize novel technologies to surpass the capabilities of real-time PCR, we successfully invented MuDT technology, an ultimate multiplex real-time PCR technology that marks a new era in the molecular diagnostics industry. Through the US FDA approval, Seegene now intends to actively enhance its leadership in the multiplex real-time PCR diagnostic testing market.”

Related Links:
US Food and Drug Administration 
Seegene