SEOUL, South Korea, Nov. 26, 2018 /PRNewswire/ — Seegene Inc. (096530.KQ), a leading developer of multiplex PCR assays, announced that multi-site clinical trials for measuring clinical performance on screening the drug resistance of Enterobacteriaceae with the Allplex™ Entero-DR assay have been undergoing in 23 hospitals affiliated with the Italian Association for Clinical Microbiology (AMCLI).
According to Grand View Research, a market research reports and consulting company, the global hospital-associated infections (HAI) diagnosis market is expected to reach from US$3.6 billion to US$11.6 billion by 2022. Currently, 600,000 people are being affected by HAI each year in the US and Europe, among which 150,000 results in death. Experts predict that by 2050, 10 million people will die from HAI mostly caused by the anti-microbial drug resistance.
Antimicrobial resistance tests are routinely being carried out using a conventional culture method, in which the bacteria are cultured for more than one day by using selective media, and when they grow, the identification is employed. It then takes 3 days for the molecular diagnosis to confirm the antimicrobial resistant genotype and make a final diagnosis. In the current medical practice involving the antimicrobial resistance testing, the benefits of molecular diagnostics, which are accuracy and promptness, are not fully utilized. Underutilization of the molecular diagnostic screening can be attributed to the perception that molecular diagnostic tests are complex and expensive.
In collaboration with Careggi University Hospital, Seegene has co-developed Allplex™ Entero-DR, and commercialized the world’s first molecular diagnostic assay that enables simultaneous screening of 8 types of resistance genes (KPC, NDM, VIM, IMP, OXA-48, CTX-M, VanA and VanB) for CRE, ESBL and VRE, directly from specimen without culturing the Enterobacteriaceae. Another advantage of this assay lies in the use of specific genes of human normal Gut Flora in the specimen as internal control (IC). This proprietary IC can monitor errors from specimen collection stage to test procedure, improving significantly the accuracy of the test results. Strengthened with these advantages, the recently launched Allplex™ Entero-DR is eyeing a good response from the market and has entered into the supply agreements with Treviso Hospital, Italy.
"When antimicrobial resistance screening is carried out by molecular diagnostics, the test result is available in 3 hours," said Professor Rossolini, the co-developer of the Allplex™ Entero-DR from Careggi University Hospital. "Not only does this rapid personalized treatment reduce the length of stay in the hospital, but it also prevents HAI through isolation or contact precautions, maximizing the efficiency of hospital management and lowers its operating costs." He added: "If the high-throughput tests are carried out at a similar price range to existing culture tests, antimicrobial resistance screening tests that were applied only to specific patients can be extended to all inpatients."
Dr. Jong-Yoon Chun, CEO and Founder of Seegene, said: "With our high-multiplex technologies and high-throughput automation system, we can offer a lower testing price to the antimicrobial resistance screening market than the conventional culture method, as well as a solution to the high-throughput market. It is possible to enter the HAI diagnostic market worth US$3.6 billion with a single item."
Seegene (KQ : 096530) is the world’s leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Seegene’s core enabling technologies – DPO™, TOCE™, and MuDT™ – are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility. Seegene’s products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene’s mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology using innovative proprietary technologies. For more information, please visit www.seegene.com.
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