Panagen 'TERT Mutation Detection Kit' Clinical Trial Completed

Submission of Class 3 Medical Device Approval Documents to the Ministry of Food and Drug Safety

[Asia Economy Reporter Kum Boryeong] Panagen has completed clinical trials for the PNAClampTM TERT Mutation Detection Kit.

Panagen announced on the 7th that it has completed clinical trials for the PNAClamp TERT Mutation Detection Kit and submitted the application documents for Class 3 medical device approval to the Ministry of Food and Drug Safety.

In 2017, Panagen succeeded in developing the TERT mutation detection kit. Recently, it successfully completed clinical trials at major domestic hospitals.

Through the success of this clinical trial, Panagen has been recognized for the excellence of its proprietary technology and the performance of its product. Panagen plans to promptly complete the approval of the in vitro diagnostic medical device and registration of new medical technology with the Ministry of Food and Drug Safety so that the TERT mutation detection kit can be used in medical practice.

TERT stands for Telomerase Reverse Transcriptase. It is a key component of telomerase, an enzyme that extends telomeres, which are repetitive nucleotide sequences located at the ends of chromosomes. This gene is considered a major cause of the unlimited proliferation of cancer cells.

In particular, when specific mutations occur in the promoter region involved in the expression of the TERT gene, it has been reported as the most accurate risk prediction indicator for the onset or recurrence rate of papillary thyroid cancer.

A Panagen official stated, "The development of the TERT mutation diagnostic kit was possible because Panagen possessed the artificial gene material PNA and the PNAClamp platform technology," adding, "Based on this technological capability, we will continue to pursue new technology development and strive to become a leading company in the molecular diagnostics field."