Seegene announced the availability of Magicplex™ Sepsis, a new multi-pathogen screening test capable of quick and accurate identification of over 90 leading sepsis-causing pathogens.
Magicplex Sepsis provides a novel and fast-acting diagnostic technique for hospitals to simultaneously verify a complex range of targets that indicate sepsis, the leading cause of death in non-coronary intensive care units worldwide. Seegene’s Magicplex Sepsis will be introduced at the 2010 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry (AACC), booth # 1800.
Sepsis is a deadly disease that leaves no clear track back to initial indications, which could include gram-positive bacteria, gram-negative bacteria or fungi. The results are devastating: the annual incidence rate of sepsis has increased 91.3 percent over the last 10 years, and every hour 25 people in the United States die from severe sepsis. One of every three patients who develop severe sepsis will die within a month. Severe sepsis, the leading cause of death in the non-coronary intensive care unit, takes more lives than breast, colorectal, pancreatic, and prostate cancers combined.
The medical challenge to be overcome is to determine the correct treatment of sepsis within the first hours of the onset of the disease. Currently physicians and clinicians have little option but to run several available molecular diagnostic tests that offer little confidence that the results will definitely identify the presence of sepsis in a patient. The alternative to these relatively quick tests is a multiple-phase blood culture test, which is a time-consuming process, or current multiplex PCR with limited range of pathogen targets and poor test specificity.
Seegene’s Magicplex Sepsis Test is a sharp break from this mold. Magicplex Sepsis is a real-time detection test that quickly and comprehensively determines the levels of suspected targets in a patient’s blood sample, and identifies drug resistant genes to better inform a diagnosis. The speed, accuracy and price of the Magicplex Sepsis Test will enable doctors and clinicians to quickly provide an appropriate treatment to head off the deadly disease.
The Magicplex Sepsis Test simultaneously screens for over 90 sepsis-causing pathogens: over 70 Gram (+) (30 Staphylococcus, 40 Streptococcus, 3 Enterococcus); 12 Gram (-); 6 Fungi; and 3 antibiotic resistant genes (mecA, vanA, vanB) can also be discriminated. The Magicplex Sepsis Test requires less than 1ml of patient’s whole blood and provides test results within three hours (after extraction). The test’s unique performance is a function of separate screening and identification steps. For example, when screening for over 90 sepsis-causing pathogens, the identification of exact pathogens can be carried out without starting from blood collection. 30 different pathogens are organized in different panels for identification and it only takes 40 minutes to detect.
"The Magicplex Sepsis Test will be the new gold standard for performing accurate, rapid and cost-effective sepsis diagnosis," said Jong-Yoon Chun, chief executive officer of Seegene. "In treating sepsis, time and accuracy are demanded. Every hour of delay in giving patients the correct antibiotics results in an 8% increase in the mortality rate."
"For doctors and clinicians performing faster diagnosis than by blood culture is a dream come true. By enabling doctors to make accurate diagnosis faster, Magicplex Sepsis can lead to improved patient outcomes in health care settings worldwide," said Hong-Soo Kim, MD, Department of Internal Medicine, Institute of Gastroenterology, Soonchunhyang University College of Medicine, Korea.
Magicplex tests are based on Seegene’s proprietary READ™ technology, which combines the advantages of multiplex in a real-time system. The result is a molecular diagnostic testing system that provides higher specificity and sensitivity over currently available PCR systems.
The READ technology of Magicplex tests is a departure from probe- and primer-based PCR methods to produce false-free detection. Magicplex test works in a simple two-step process: first specifically amplifying the DNA sequence of target pathogens, then simply reading those signals using any real-time PCR instrument.
Magicplex Sepsis Test will not be available in the USA until regulatory clearance.