The Ministery of Food and Drug Safety said on Jan. 8 it approved a domestically developed genetic test reagent that assists in diagnosing bladder cancer as a newly developed medical device. A newly developed medical device refers to a medical device in which at least one of the mechanism of action, materials and supplies, method of use, or performance is new compared with existing products.
The approved genetic test reagent is intended for 40-year-old patients with hematuria and suspected bladder cancer. It applied the methylated gene PENK in patient urine as the analyte. It detects PENK using real-time polymerase chain reaction to assist in diagnosing bladder cancer.
The Ministery of Food and Drug Safety said, "Clinical effectiveness has improved compared with existing diagnostic methods," and added, "We will ensure that patients can be diagnosed with a medical device that is safe."