• Accelr8 Technology (Denver) said research investigators at the Denver Health Medical Center have presented results of a study using the company's BACcel rapid diagnostic system. The purpose of the study was to estimate the potential impact of rapid diagnosis on reducing the use of suboptimal and inactive therapy caused by delays in obtaining results from standard lab cultures. The investigators analyzed stored isolates using a prototype BACcel system, measuring the test's accuracy and speed in classifying MRSA and susceptible strains in the isolates that caused the original infections. They found the BACcel identification test had 100% sensitivity and 89% specificity in identifying MRSA within four hours of analysis of the isolates.
• Nonin Medical (Minneapolis) has demonstrated the first Continua pre-certified pulse oximeter at the 5th annual Connected Health Symposium in Boston. Nonin said it collaborated with other companies in recent months to successfully complete the international connectivity standard for the interoperability of pulse oximeters, ISO/IEEE 11073-10404. "This is a significant step toward eliminating proprietary interfaces, allowing pulse oximetry equipment to communicate freely with other devices," said Kurt Kermes, standards architect at Nonin Medical.
• Roche Molecular Diagnostics (Pleasanton, California) said the FDA has approved the COBAS AmpliPrep/COBAS TaqMan HCV Test for use in the U.S. The test uses Roche's real-time PCR (polymerase chain reaction) technology to quantify the amount of hepatitis C RNA in a patient's blood. Physicians use hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy. The test is designed for use on the first fully automated, FDA-approved, real-time PCR platform, providing sample-in/results-out capability. The system menu includes an FDA-approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests.
• Sanarus Medical (Pleasanton, California) said the American College of Surgeons Oncology Group, which just initiated a National Cancer Institute-funded Phase II clinical trial exploring the use of cryoablation therapy in the treatment of invasive breast carcinoma, has selected the Visica 2 treatment system from Sanarus as the exclusive technology to be used in the cryoablation portion of the study. The Sanarus Visica System has predominately been used in the cryoablation of non-cancerous tumors called fibroadenomas since its initial FDA market clearance in March 2002. This office-based procedure, which usually takes less than 20 minutes, involves placing a small needle into the center of the tumor using ultrasound guidance and subsequently freezing and killing the tumor. Sanarus said the safety and efficacy of cryoablation have been well established in more than 2,000 fibroadenomas that have been treated with the system to date.
• St. Jude Medical (St. Paul, Minnesota) reported the publication of a study on the St. Jude Medical Biocor stented tissue valve that found the valve provided excellent long-term durability as a replacement for the aortic valve in patients 65 and older. The study, which appears in the October issue of the Annals of Thoracic Surgery, evaluated the 20-year durability of the Biocor porcine valve in the aortic position. According to the study, over the 20-year follow-up period, the Biocor valve was found to perform well on key measures of long-term performance including freedom from reoperation due to structural valve deterioration (the rate at which patients remain free from another operation related to degeneration that could affect the valve's proper functioning).