Panagene, a domestic molecular diagnostics company, said on Tuesday that it obtainedapproval from the Ministry of Food and Drug Administration (MFDS) for its PNA Clamp TERT Mutation Detection Kit.

The telomerase reverse transcriptase (TERT) gene is a key factor in elongating telomeres, a repeatable sequence present at the end of the chromosome, and is also the main cause of the infinite proliferation of cancer cells.

According to the American Thyroid Association, genes are the most accurate risk predictor for detecting incidences or recurrences of papillary thyroid cancer. Thus, they must be tested as a major biomarker to predict the prognosis and risk of metastasis in patients with brain tumors, said a study published by the ATA in 2015.

However, base sequencing characteristics, a key DNA amplification technique in molecular diagnostics, greatly reduce the efficiency of polymerase chain reaction (PCR). Accordingly, there are many errors in the determination of test results with the usual PCR method and also the test itself is difficult to conduct as there are no diagnostic products that exist worldwide.

Consequently, Panagene has succeeded in developing this TERT genetic diagnostic product by using the peptide nucleic acid (PNA)-based PROBE, an artificially created gene analogue. They accomplished this by fusing its innovative PANAmp technology with PNAClamp technology to overcome the difficulties caused by sequencing genes.

“We are now proud to be the first company in the world to supply a TERT diagnostic kit to medical sites thanks to the recent permit from the MFDS,” said a company official. "The acquisition of this license also confirms the superiority of Panagene's technology applied to molecular diagnostic technology."

The Panagene official added that the company will continue to devote itself to the development of new technologies and products, and strive to lead the in vitro diagnostic medical device market in the field of molecular diagnostics.