November 2022
SML Genetree’s Helicobacter pylori (Formalin-Fixed-Paraffin-Embedded (FFPE) samples) diagnostic kit has obtained official approval from the South Korean Ministry of Food and Drug Safety
SML Genetree (CEO Ahn Ji-hoon)'s Ezplex® HP-CLA Real-time PCR kit received official domestic approval (Ex-Vitro License No. 19-825) from the South Korean Ministry of Food and Drug Safety (MFDS) on November 2, 2022.
Until now, H. pylori diagnosis was made by removing a small amount of the patient’s gastric tissue through an endoscope and observing the bacteria under a microscope, performing lengthy culture techniques and/ or checking for the presence of H. pylori DNA through polymerase chain reaction (PCR) testing. In particular, H.pylori could be detected only with gastric tissue collected with sterile endoscopy and immediate testing (according to the Ministry of Food and Drug Safety's manufacturing permission standard.
The Ezplex® HP-CLA Real-time PCR kit can rapidly identify the presence of H.pylori and two mutations that confer clarithromycin antibiotic resistance (A2142G, A2143G) (less than 2 hours post DNA extraction) using FFPE tissue, a specimen that was not previously permitted. The use of FFPE tissue was approved based on clinical data, so patients are no longer required to undergo endoscopy.
Ahn Ji-hoon, CEO of SML Genetree, says, “We are delighted to receive permission from the Ministry of Food and Drug Safety for the Ezplex® HP-CLA Real-time PCR kit, which can utilize FFPE tissue for the first time in Korea. Patient convenience will be improved, and it will greatly assist in early detection of gastric cancer and selection of appropriate treatment.”
H. pylori is a gram-negative bacteria that can inhabit human gastric mucosa for a long time causing chronic gastritis, peptic ulcer, gastric marginal zone B-cell lymphoma, and gastric cancer. It is estimated that more than half of the world's population is infected with H. pylori, and once infected, the infection persists for several years or a lifetime with spontaneous healing known to be rare. The infection rate of H. pylori is inversely proportional to the socioeconomic level, and the prevalence of infection increases with age. As a result of epidemiological studies, even though H.pylori seroprevalence in Korea is decreasing, the incidence and mortality of gastric cancer in Korea and worldwide is quite high with adult infection rates as high as 65-75%.
November 2022
SML Genetree’s Helicobacter pylori (Formalin-Fixed-Paraffin-Embedded (FFPE) samples) diagnostic kit has obtained official approval from the South Korean Ministry of Food and Drug Safety
SML Genetree (CEO Ahn Ji-hoon)'s Ezplex® HP-CLA Real-time PCR kit received official domestic approval (Ex-Vitro License No. 19-825) from the South Korean Ministry of Food and Drug Safety (MFDS) on November 2, 2022.
Until now, H. pylori diagnosis was made by removing a small amount of the patient’s gastric tissue through an endoscope and observing the bacteria under a microscope, performing lengthy culture techniques and/ or checking for the presence of H. pylori DNA through polymerase chain reaction (PCR) testing. In particular, H.pylori could be detected only with gastric tissue collected with sterile endoscopy and immediate testing (according to the Ministry of Food and Drug Safety's manufacturing permission standard.
The Ezplex® HP-CLA Real-time PCR kit can rapidly identify the presence of H.pylori and two mutations that confer clarithromycin antibiotic resistance (A2142G, A2143G) (less than 2 hours post DNA extraction) using FFPE tissue, a specimen that was not previously permitted. The use of FFPE tissue was approved based on clinical data, so patients are no longer required to undergo endoscopy.
Ahn Ji-hoon, CEO of SML Genetree, says, “We are delighted to receive permission from the Ministry of Food and Drug Safety for the Ezplex® HP-CLA Real-time PCR kit, which can utilize FFPE tissue for the first time in Korea. Patient convenience will be improved, and it will greatly assist in early detection of gastric cancer and selection of appropriate treatment.”
H. pylori is a gram-negative bacteria that can inhabit human gastric mucosa for a long time causing chronic gastritis, peptic ulcer, gastric marginal zone B-cell lymphoma, and gastric cancer. It is estimated that more than half of the world's population is infected with H. pylori, and once infected, the infection persists for several years or a lifetime with spontaneous healing known to be rare. The infection rate of H. pylori is inversely proportional to the socioeconomic level, and the prevalence of infection increases with age. As a result of epidemiological studies, even though H.pylori seroprevalence in Korea is decreasing, the incidence and mortality of gastric cancer in Korea and worldwide is quite high with adult infection rates as high as 65-75%.