First Approval of Domestically Developed 'Innovative Medical Device' for Auxiliary Diagnosis of Bladder Cancer

MFDS Approves Manufacturing of "Tumor-Related Genetic Test Reagent"

The Ministry of Food and Drug Safety announced on January 9 that it has approved a domestically developed 'genetic test reagent' as an innovative medical device for the first time, applying the analysis of a methylated specific gene (PENK) in patient urine as a biomarker for the auxiliary diagnosis of bladder cancer.

An innovative medical device refers to a medical device that is entirely new in at least one aspect-such as its mechanism of action, raw materials, usage method, performance, or intended use-compared to existing products.

The PENK (Proenkephalin) protein is one of the proteins involved in cell growth regulation and stress-induced cell death. When the PENK gene is methylated, the PENK protein is not expressed.

The newly approved genetic test reagent detects methylated PENK in the urine of patients aged 40 or older who present with hematuria and are suspected of having bladder cancer, using real-time polymerase chain reaction (PCR). It is used to assist in the diagnosis of high-grade bladder cancer (which has a poor prognosis but no invasion below the mucosal layer) or invasive bladder cancer (tumors that have invaded below the mucosal layer).

This genetic testing method has demonstrated improved clinical effectiveness (clinical sensitivity and specificity) compared to conventional immunodiagnostic products based on protein assays previously used for diagnosis.

The Ministry of Food and Drug Safety stated, "We will continue to fulfill our responsibility and make every effort to ensure that the public can enjoy healthy lives by using safe and high-quality medical devices through prompt approval and review processes, and that more patients have access to diagnostic and treatment opportunities."