Seegene's New Rapid Sepsis Test Analyzes 68 Indicators for Deadly In-Hospital Disease

Seegene's Seeplex^® Sepsis multi-pathogen screening test introduced today at the 2008 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry (AACC) brings 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.

This killing disease leaves a muddy footprint providing no clear track back to the initial indications, which may have been Gram-positive bacteria, Gram-negative bacteria or one of eight fungi.

The results are devastating with 18 million cases of severe sepsis reported each year at a cost of over $35 billion. More tragic is the fact that sepsis causes shock, coma, or death for patients who entered a hospital to be treated for a completely unrelated health condition.

The medical problem is determining the correct treatment during the first days of the disease. Currently physicians and clinicians need to choose among several tests with little confidence the results will definitely identify that a patient does or does not have the disease. Alternatively, a multiple-phase blood culture test covering a range of specific targets can be ordered, though it is an expensive process requiring time against a disease that quickly takes hold and rapidly deteriorates a patient's condition.

The Seeplex^® Sepsis Test from Seegene is a single lab test that quickly determines the levels of suspected targets in a patient's blood sample to better inform the diagnosis and create an opportunity for quickly applying an appropriate treatment to head off the disease.

In a recent clinical study in Korea, the Seeplex testing approach demonstrated higher sensitivity than the blood culture test methodology. Out of 370 hospital patients suspected of having sepsis, 53 patients tested positive using the Seeplex Sepsis Test while 32 patients tested positive using the blood culture method.

Of additional significance to those on the front lines of disease control was the fact that the Seeplex Test identified those higher rates of infection on the same day that blood samples were taken. This is in contrast to blood culture which took 3-4 days to return test results.

The Seeplex Sepsis Test simultaneously screens for 64 sepsis-causing pathogens: 48 Gram (+) bacteria, 10 Gram (-) bacteria, and 6 fungi. Additionally, four drug resistant genes (vanA, vanB, mecA, and blaSHV) can also be discriminated. The Seeplex Sepsis Test requires only 0.4 ml of patient's whole blood and provides test results in five hours.

"The Seeplex^® Sepsis DNA test is a fundamental breakthrough for accurate, rapid and cost-effective sepsis diagnostics," said Jong-Yoon Chun, chief executive officer of Seegene. "We believe the Seeplex testing system opens a new window for not only saving lives but also furthering understanding of this complex disease by providing precise information of infected pathogens at the earliest possible stage."

The cost of the test is significantly lower than any other methods in the market. Not only will it help improve patient management in terms of expenses and time but also reduce unnecessary use of antibiotics, resulting in appropriate treatment to head off sepsis at the earliest possible stage of disease development.

Seeplex Sepsis Test is not for diagnostic procedures in the USA and will not be available in the USA pending regulatory approval.

The novel technique behind the new test technique is Seegene's proprietary DPO™ (dual priming oligonucleotide) primer system that amplifies DNA sequence using established polymerase chain reaction (PCR) but more rapidly screens for targeted bacteria generating consistently high PCR specificity while preserving a sensitivity as high as that of single PCR.