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Sep 30, 2008

Molzym’s Broad-Spectrum PCR Test for Sepsis Sanctioned in Europe

  • Molzym received European market approval for its diagnostic kit for sepsis, SepsiTest™. The product is a PCR-based test that can detect more than 345 relevant sepsis germs in less than four hours. This is a significant improvement over the current culture methods that take, on average, 48 hours.

    Blood cultures are limited when detecting fastidious organisms or when antibiotic therapies have already been administered. As for other molecular diagnostics, “Roche Diagnostics recently launched a test called Septifast. This test detects only 25 bacteria,” according to Jan Detmers, director business development.

    SepsiTest will cost €81.50, says Detmers. According to European in vitro diagnostic law, SepsiTest can be marketed in the following countries since it has the CE-IVD-marking: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Spain, Slovakia, Slovenia, Sweden, and the U.K.



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