Vivione Biosciences Inc. is pleased to announce the successful completion of its early stage pilot study at the Cleveland Clinic focused on applying its RAPID-B bacterial detection platform to the primary screening of suspected urinary tract infections (UTIs).
"While our primary goal was to gather substantial data on clinical samples for later modification of the system's software algorithms, it was clearly evident from the first day forward we could accurately detect clinically defined UTIs at the time the sample arrived in the lab, in essence 18-24 hours faster than traditional methods," said Chief Medical Officer, Dr. Matthew Gombrich. "Our next phase will expand on the 100% sensitivity seen in this evaluation to determine the clinical specificity of the system in a larger clinical context," Gombrich continued.
"This is once again proof that RAPID-B has a place not only in the Food Safety sector, as was demonstrated by our AOAC approvals, but in the clinical realm as well. We're thrilled by these preliminary results and look forward to expanding the data for regulatory approval and commercializing the product for rapid, high sensitivity bacterial screening in the clinical setting. NIH estimates there are over 500,000 hospital-associated UTIs annually and we feel the RAPID-B system will offer an excellent means to both diagnose and lower costs associated with the disease," said Kevin Kuykendall, CEO of Vivione Biosciences.
The Vivione's RAPID-B platform, which is currently commercialized in both the Food Safety and the Oil and Gas sectors, is a highly sensitive and rapid platform for detecting bacteria in complex matrices (like beef or frac water). Vivione is currently applying the system not only to urinary tract infection screening but blood infections and meningitis screening as well. Vivione has also recently filed IP focused around rapid antibiotic susceptibility determination using the RAPID-B platform.
"While our primary goal was to gather substantial data on clinical samples for later modification of the system's software algorithms, it was clearly evident from the first day forward we could accurately detect clinically defined UTIs at the time the sample arrived in the lab, in essence 18-24 hours faster than traditional methods," said Chief Medical Officer, Dr. Matthew Gombrich. "Our next phase will expand on the 100% sensitivity seen in this evaluation to determine the clinical specificity of the system in a larger clinical context," Gombrich continued.
"This is once again proof that RAPID-B has a place not only in the Food Safety sector, as was demonstrated by our AOAC approvals, but in the clinical realm as well. We're thrilled by these preliminary results and look forward to expanding the data for regulatory approval and commercializing the product for rapid, high sensitivity bacterial screening in the clinical setting. NIH estimates there are over 500,000 hospital-associated UTIs annually and we feel the RAPID-B system will offer an excellent means to both diagnose and lower costs associated with the disease," said Kevin Kuykendall, CEO of Vivione Biosciences.
The Vivione's RAPID-B platform, which is currently commercialized in both the Food Safety and the Oil and Gas sectors, is a highly sensitive and rapid platform for detecting bacteria in complex matrices (like beef or frac water). Vivione is currently applying the system not only to urinary tract infection screening but blood infections and meningitis screening as well. Vivione has also recently filed IP focused around rapid antibiotic susceptibility determination using the RAPID-B platform.