Curetis N.V., a developer of next-level molecular diagnostic solutions, today announced that it has received a notice of allowance from the United States Patent & Trademark Office (USPTO) for U.S. Patent Application 14/232,391 (“Apparatus and Method for a Lysis of a Sample, in Particular for an Automated and/or Controlled Lysis of a Sample") covering its Unyvero Lysator patient sample preparation technology. Patents by Curetis covering this technology have been granted in Australia, China and Japan, and patent applications are pending in Europe and Canada.

The Unyvero Lysator technology combines mechanical, enzymatic, chemical, and thermal lysis for the liquefaction of patient samples, inactivation of pathogens, and disruption of the microbial cells and allows for automated processing of any native patient sample without complex manual handling. The technology enables efficient subsequent extraction of bacterial or fungal DNA from even the most challenging patient samples for analysis with the Unyvero Application cartridges or other molecular diagnostics technologies such as next generation sequencing (NGS).

“Allowance of this key patent by the USPTO is further strengthening Curetis’ global IP portfolio,” said Dr. Gerd Luedke, Director Innovation, Technology & IP of Curetis. “The Unyvero Lysator technology is crucial for the release of the genetic material from pathogens for diagnostic purposes, as well as reliable deactivation of the microorganisms in the sample. The sample preparation step is vital for safe and rapid identification of pathogens and antibiotic resistance markers with high specificity and sensitivity via the Unyvero application cartridges.”

“This patent under scores the unique ability of Curetis’ Lysator to process very challenging and heterogeneous native patient samples. This is particularly true for tracheal aspirates analyzed with the Unyvero LRT Cartridge, our first application for the U.S. market, for which we expecting a near-term FDA clearance decision” said Dr. Achim Plum, CBO of Curetis Group. “Additionally, we have partnered with MGI, a subsidiary of Chinese BGI Group, to apply our Lysator technology in a fully automated NGS workflow that allows the processing of any type of native clinical sample and subsequent NGS-based detection of microbial pathogens and genetic markers for antibiotic resistances.”