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Groundbreaking test enables rapid and reliable routine diagnostics

Sepsis: Broad-spectrum PCR-Test receives CE-IVD approval


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Sepsis: Broad-spectrum PCR-Test receives CE-IVD approval ©pressetext
Sepsis: Broad-spectrum PCR-Test receives CE-IVD approval ©pressetext
2008-09-30 13:06:03 -

Bremen/Germany (pts/30.09.2008/12:57) - SepsiTest™ http://www.sepsitest.com is a novel PCR test for early and rapid diagnosis of sepsis. In less than four hours the broad-spectrum screening assay detects more than 345 relevant sepsis germs. Today's conventional microbiological methods usually deliver results, on an average, only after 48 hours. SepsiTest™ received CE-IVD-marking according to European in-vitro diagnostic law and is now available for routine sepsis diagnostics.

Sepsis (coll. blood poisoning) is a systemic inflammation of the whole body ultimately leading to multiple organ dysfunctions. Even though the latest intensive care technology can maintain organ function in critical phases for some time, sepsis is an extremely severe prognosis. Despite greatest efforts, septicemic patients today still have a mortality rate of 30-50%. Several researchers have estimated that, in the U.S. alone, more than 580 patients die from sepsis every day. The survival rate greatly depends on an early therapy including targeted antibiotic treatment.

Today, sepsis-causing pathogens are usually identified by a traditional microbiological method: the so-called blood culture. Blood culture tests normally deliver results after 2 to 5 days and, in some cases, the analysis takes even longer. Moreover, blood cultures are limited when detecting fastidious organisms or when antibiotic therapies have already been administered. Therefore, molecular biologists have been working for quite some time on rapid sepsis screening technologies. In contrast to other molecular tests, the broad-spectrum SepsiTest™ detects all relevant pathogens and, thus, for the first time enables very targeted antibiotic therapies. Latest research from SepNet, the European sepsis network, showed dramatically increased survival rates for sepsis patients receiving early and targeted antibiotic treatments.

About SepsiTest™:
SepsiTest™ is a broad-range PCR test developed and manufactured by Molzym, Germany. The rapid screening test recently has received CE-IVD-marking according European in-vitro diagnostic directive (EN ISO 98/79/EG) and is now available for routine sepsis diagnostics. SepsiTest™ has been verified on a broad spectrum of more than 345 sepsis-relevant pathogens. SepsiTest™ is, thus, the first PCR test detecting all relevant sepsis-causing strains in one test.
"Broad-spectrum molecular sepsis diagnostics will for the first time enable early targeted treatments and SepsiTest™ will greatly support clinicians in their bed-side decision-making," says Professor Michael Lorenz, chief-scientist at Molzym.

About Molzym:
Molzym GmbH & Co. KG, headquartered in Bremen, Germany, is a manufacturer of innovative products for molecular diagnostics. Based on proprietary, patented technologies Molzym's kits and molecular diagnostic tools focus on the selective isolation of pathogen DNA from whole blood, robust and contamination-free PCR reagents and the molecular detection and identification of bacteria and fungi.
For more than 5 years, the world market of molecular diagnostics shows a compound annual growth rate of about 15%. Molzym regards itself as the technology and market leader in broad-spectrum molecular diagnostics. This market is believed to be one of the most important growth markets in diagnostics because of emerging infectious diseases and increasing antibiotic resistances around the world.

Press contact:
Jan Detmers, Ph.D. Fon: ++49 (0) 421-2209-777-0 Internet: http://www.sepstitest.com Email: info@molzym.com

Pictures for download: http://www.sepsitest.com/en/content/view/60/56/

SepsiTest™ is a registered trademark of Molzym GmbH & Co. KG, Bremen, Germany. (end)

submitter: Molzym GmbH & Co. KG
contact person: Dr. Jan Detmers
email: info@molzym.com
phone: +49(0)421-22097 770

[ source: http://newsfox.com/pte.mc?pte=080930034 ]
[ photos: http://newsfox.com/show_attach.mc?pte=080930034 ]


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