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Genomic Profiling Systems Receives NIAID Funds to Continue Development of Emergency Diagnostic Testing Platform to Support Biodefense Preparedness

Posted on: Friday, 12 August 2005, 12:00 CDT

MultiPath(TM) System Initially Aimed at Rapid, Ultra-sensitive On-site Anthrax Testing in Clinical Settings

Genomic Profiling Systems Incorporated (GPS) announced today that it would receive a three-year $4.1 million Phase II SBIR grant from the National Institute of Allergy and Infectious Disease (NIAID) to develop a "surge" testing platform for rapid and ultra-sensitive diagnosis of anthrax. The MultiPath(TM) system will enable emergency testing on a mass scale, as would occur following a major biowarfare attack. According to the company, the platform will also be useful for key clinical and industrial applications including flu testing and detection of pathogens in food.

Present methods for anthrax testing are incapable of accommodating large surges in testing. Currently, hospital laboratories presumptively diagnose anthrax and public health laboratories subsequently confirm the finding. Testing includes one-to-two day blood cultures and other complex assays. As stated in a Government Accountability Office (GAO) report to the US Senate in 2003, in reference to the 2001 anthrax scare, "Routine laboratory and radiological testing did not always clearly signal anthrax infection and, even after physicians did suspect it, the laboratory tests needed to confirm it were time-consuming, laborious and required that samples be sent to specialized laboratories."

The research reported by this grant will enable prototype development of an automated portable MultiPath(TM) instrument and consumable test cartridges designed for rapid, high capacity, easy to implement emergency diagnostics. In its Phase I SBIR program, GPS demonstrated ultra-sensitive detection of bacteria, viruses and toxins--targets that represent the full spectrum of biothreat agents. "The system detected bacteria and soluble protein markers at levels that are thousands of times lower than achievable with standard commercial strip tests" commented Dr. Donald Straus, VP of Research and CSO of Genomic Profiling Systems. According to Dr. Sal Salamone, CSO of Saladax Biomedical and former VP of Research and Development at Roche Diagnostics, "GPS has been able to develop a rapid detection system with excellent lower limits of detection. The performance of the system coupled with its simplicity will make it ideal for applications where speed and sensitivity are required such as in the event of a biowarfare attack or infectious outbreak."

Bob Linke, president and CEO of Genomic Profiling Systems commented: "We are very pleased that our Phase I validation of the MultiPath(TM) technology has resulted in our second significant NIAID award. GPS is proud to be a leading innovator in emergency pathogen diagnostics. Our biowarfare testing products will be crucial for judiciously targeting powerful new therapeutics to the patients who need them. This is what it will take in the event of the unthinkable. Once developed, this rapid, ultra-sensitive testing platform will address emerging demands for detection of molecules and microbes in the clinical, industrial and biodefense markets."

About Genomic Profiling Systems

Genomic Profiling Systems, based in Bedford, MA, is a privately held company developing groundbreaking products that address significant unmet needs in pharmaceutical manufacturing, the food industry, healthcare, and biodefense global markets. The Company's automated testing platforms and products deliver rapid, ultra-sensitive detection of microbiological contamination, infection, and disease markers. In early 2006, GPS will launch its first product, the Growth Direct(TM) Test, which rapidly detects microbiological contamination in pharmaceutical products. This new tool will help pharmaceutical manufacturers improve their manufacturing efficiencies in accordance with the FDA's Process Analytical Technology (PAT) initiative. For more information, go to www.genprosys.com.

Source: Business Wire

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