The growing problem of infectious diseases and hospital-based infections has brought to the market and near market significant innovation to in rapid pathogen detection systems.  According to data from the CDC National Nosocomial Infections Surveillance System, MRSA has become a national epidemic.  CDC estimates that in 1995 approximately 38% of staph infections among U.S. intensive care patients were MRSA.  In 2004, approximately 62% were MRSA.

Vendors of organism specific culture media such as Acumedia, Alpha-Tec Systems, BD Diagnostics/Difco, bioMérieux, Fisher Scientific/Remel/Oxoid, Hardy Diagnostics, Pro-Lab, Sigma Aldrich, and Wampole have introduced a wide range of culture media and rapid identification kits for the faster identification of common community and hospital pathogens.  These traditional approaches are being challenged by microbiology and virology detection using non-traditional techniques including mass spectroscopy, miniaturized molecular devices and flow cytometry.  A sample of new microbiology test systems.

Accelr8 Technology Corp. is developing its Quantum Microbiology molecular analysis used in its BACcelr8r rapid pathogen diagnostic development program.  Bacterial analysis (identification, counting, growth measurement, and antibiotic resistance testing) is performed in a fluidic device without the use of bacterial cultures.

Advanced Analytical Technologies has developed the RBD 3000. based on the principles of flow cytometry and robotics for sample processing.  It is currently designed for the rapid evaluation of microbial biomass and total viable organism counts for industrial microbiology.  However, with a little imagination it is possible to see how with the use of membrane protein specific antibodies and probes the system could be adapted to clinical applications. A robotic arm moves the sample through a series of steps that includes vial cap removal and reagent addition.

Bayer Diagnostics Division is investing in new techniques.  The company is collaborating with  Signet Laboratories to develop immunoassays that detect two markers of inflammation - uristatin and bikunin, found in blood and urine.  The biomarkers are useful in the detection of sepsis, meningitis, respiratory infection, urinary tract infection, viral infection, and bacterial infection.  Bayer has also entered into a collaboration with Stratagene to customized Stratagene's Mx3005P molecular instrument systems for use in a new platform for viral and non-viral infectious diseases.

Bruker Daltonics introduced its MALDI BioTyper system for the identification and classification of microorganisms using ribosomal protein fingerprints measured by MALDI-TOF mass spectrometry.  The system detects the characteristic protein expression patterns of microorganisms, such as bacteria, yeasts and fungi.  The MALDI BioTyper is used after an overnight culture growth.  Applications include microorganism detection and identification in environmental analysis, food safety and water quality.

Genefluidics is developing a biosensor (microfabricated electrochemical sensor array) to identify the infection-causing gram-negative bacteria species shown to be responsible for the majority of urinary tract infections.  Using culture- and PCR-independent molecular identification the sensor provides results in 45 minutes.  Research using the device reported in the February 2006 issue of the Journal of Clinical Microbiology, describes the device - "The ability of the sensor to provide genotypic identification of uropathogens and to rapidly differentiate between bacterial pathogens is clearly superior to current clinical microbiology approaches, which are limited by the growth rates of bacteria and typically require at least 48 hours from sample collection to reporting.  The sensor has several key advantages over PCR, one of which is that no target amplification is required.  The sensor works very well on crude bacterial lysates from clinical urine specimens."

Micromass, a division of Waters Corporation has introduced the MicrobeLynx System that uses mass spectrometry to perform ID/MIC analysis of bacteria from a cultured colony.

Roche Diagnostics has developed SeptiFast, a PCR-based test for sepsis.  The test, which would be priced at about $100 per patient, is expected to come to market in 2006 and would be marketed to hospitals.

STMicroelectronics and Mobidiag are developing a lab-on-chip application for DNA-based detection of sepsis-causing bacteria, using a diagnostic panel from Mobidiag that runs on STMicroelectronics's In-Check platform.  The platform uses a pathogen panel to identify ten sepsis-causing bacterial species as well as MRSA strains from positive blood culture samples.  Clinical trials are planned for early 2006, with the final product including validated controls, assay optimization, and diagnostic reporting software to be launched in 2007.

Thermal Gradient, Inc. has completed a prototype 30-cycle PCR device that the company claims can amplify DNA in just 4.4 minutes.  The company is planning to develop a POL and POC system for infections such as HIV, hepatitis, methicillin-resistant staphylococcus or the multiple causes of sepsis.

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Updated 3/16/06