Seegene said Monday that it has started to conduct the clinical trials of its Allplex Entero-DR Assay, an intestinal bacterial antibiotic resistance screening test reagent, at 23 hospitals under the Italian society of microbiology.
According to the Grand View Research, a U.S. research firm, the global hospital-acquired infection (HAI) diagnostic market will reach $11.6 billion by 2022. About 600,000 people contract HAI every year in the United States and Europe, and 150,000 die from the infection. Most HAI comes from antibiotic-resistant bacteria.
Experts estimate that in 2050, deaths due to antibiotic resistance will reach 10 million people per year.
Currently, hospitals conduct antibiotic resistance testing using the traditional method of "culture screening." The method uses a selective medium specific for the bacteria and cultures it for a day. Afterward, if the bacterium grows the hospital starts identifying the bacteria.
The process takes three days to confirm the genotype of the resistance through molecular diagnosis.
However, such a process takes away the advantages of molecular diagnostics, such as accuracy and promptness. And although molecular diagnostic screening tests can remove such barriers, its introduction into the medical market has not followed due to the prejudice that these tests were expensive and complicated.
To overcome such problems, Seegene released the world's first molecular diagnostics reagent that can screen eight kinds of antibiotic genes -- KPC, NDM, VIM, IMP, OXA-48, CTX-M, VanA and VanB – specific to Carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta-lactamases (ESBL) vancomycin-resistant enterococci (VRE), with Florence University Hospital in Italy.
Another competitive advantage of this reagent is that it uses specific genes in the body as internal control agents, the company said.
This method enables medical professionals to monitor the error of the inspection process from sampling, which in turn, can improve the accuracy of the results.
Based on such strengths, the company has signed a supply contract with Treviso Hospital in Italy and has gained a good response from the market.
“The company also owns a simultaneous multi-technology and large-scale automated inspection system, which can lower the test price and easily conduct mass inspections compared to the conventional cultivation method,” Seegene CEO Chun Jong-yoon said. “With this single reagent, we expect to enter the $3.6 billion HAI diagnostic market.”