Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing more than $ billion annually More than million blood culture bottles are produced annually with a market size greater than $ B in the US and EU alone The two year phase II period spanned February to February R AI The developments funded in part by this grant have created a new paradigm to diagnose blood stream infection causing sepsis The work of this grant has assisted in creating the SpecID blood culture system which the company is now commercializing The SpecID solution replaces the present step process for characterization of blood samples currently divided into detection of infection an obligatory Gram stain for all positive cultures performed on the bench by trained technician and then species ID by MALDI TOF again requiring skilled sample preparation The SpecID solution combines faster detection more accurate Gram status determination than the benchtop stain and ID more accurate than MALDI in a single fully automated step which reduces the time to ID streamlines lab workflow and saves significant cost The result is improved patient outcomes and improved lab operating performance The objectives of this Commercialization Readiness Pilot CRP Program proposal reflect the key goals not supported by the Phase II or Phase IIB programs but required to achieve commercial market entry of the SpecID blood culture system including development of blood culture media manufacturing processes development of quality control and documentation systems FDA strategy to achieve k approval and development of the SpecID blood culture instrument and blood culture bottle sensor attachment Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing for than $ billion annually Rapid identification of the infection is critical for effective treatment The ultimate goal of this project is to bring hospitals a new technology solution that reduces the time to identification in a single automated instrument The result is improved patient outcomes and importantly in today s cost critical healthcare system the solution is less expensive than current practice