miacom diagnostics: Diagnosing Pneumonia Pathogens Directly from Respiratory Specimen

miacom diagnostics multiplex test delivers exact results in just 40 minutes

DUESSELDORF, Germany--(BUSINESS WIRE)--miacom diagnostics specializes on the development and production of medical tests for the detection of acute infectious diseases. The company with headquarters in Duesseldorf, Germany, was founded in 2006 based on the vision of developing faster and better diagnostic methods than currently available to the healthcare system. New diagnostic tests, delivering precise information on an infection’s causative agent faster and with higher precision, can reduce the morbidity and mortality for many patients. In addition to its existing sepsis kits miacom, diagnostics is now presenting a further CE-marked product based on the same proprietary technology. It is targeted at the rapid detection of clinically most relevant pneumonia causing pathogens. The lucesco pneumonia I test simultaneously detects the twelve most important gram-negative bacteria. In as little as 40 minutes a physician may know what he and the patient are fighting against – one to two days earlier than current tests allow. The fast test results significantly increase the chances for a targeted and successful treatment. Detection is performed directly on respiratory secretions, eliminating the hitherto required tedious culturing of pathogens.

Pneumonia is the most common serious infectious disease with a fatal outcome in Western Europe. Especially older people, children, people with a weakened immune system, and mechanically ventilated patients are at risk. Estimates suggest that approx. three to four million people worldwide die of pneumonia every year. In Germany alone, some 200,000 people contract pneumonia every year. In hospitals, especially in intensive care units, pneumonia is the most common acquired infectious disease. With the new lucesco pneumonia I test the most important bacteria, e.g. Pseudomonas aeruginosa, Klebsiella pneumoniae or Escherichia coli can now be identified directly in just 40 minutes, without requiring a culture from respiratory specimen such as sputum, tracheal or bronchial secretions and bronchoalveolar lavage fluid.

“Current methods have several limitations. Apart from the 24 to 48 h it takes for the results to be available, the major problem of bacterial culturing is its low sensitivity. Newer approaches like gene amplification (PCR) or mass spectrometry based methods are difficult to use in a typically very viscous respiratory sample. Furthermore, differentiating between normal, healthy bacterial flora and the infectious pathogen in number and kind is challenging“, explains Dr. Mirko Stange, Managing Director of miacom diagnostics GmbH. miacom has chosen a new approach: the viscous material is liquefied in a simple and procedure, and the pathogens are made visible directly in the patient material via microscope. The physician may receive the results within just 40 minutes. “One additional advantage of the direct detection approach is that it can easily identify multiple infections in patients and present a qualitative assessment of the prevailing pathogen and the severity of the infection.”

The lucesco pneumonia I test will be commercially available in Europe from October 2010. The U.S. approval is in process. A pneumonia II test for the most important gram positive bacteria is currently under development. miacom diagnostics will present the pneumonia I test at ICAAC, the Interscience Conference on Antimicrobial Agents and Chemotherapy, in Boston, from September 12. - 15., as well as latest results from a clinical study currently conducted at the University Hospital Duesseldorf.