The European Organization for Research and Treatment of Cancer (EORTC; Vedbaek, Denmark) has undertaken a multi-institutional prospective randomized clinical trial on 719 late-stage epithelial ovarian cancer patients. In this study, Oncotech (Tustin, California) EDR Assays were performed on biopsies obtained from 246 patients. Results clearly demonstrate that resistance to carboplatin, as identified by the Oncotech EDR Assay, was a significant independent predictor for response to first-line treatment in advanced ovarian cancer patients. The clinical trial results demonstrate that the use of the Oncotech EDR Assay predictive test can predict resistance to platinum-based chemotherapy before therapy is initiated. These results are important to ovarian cancer treating physicians, Oncotech said, since ovarian cancer is known to show resistance to platinum-based agents. Currently, the standard first-line treatment regimen for late-stage ovarian cancer contains platinum-based chemotherapy.

• Ortho Clinical Diagnostics (Raritan, New Jersey) reported FDA clearance for its Vitros 5600 Integrated System. This system is designed to integrate clinical chemistry and immunoassay testing to increase laboratory productivity and will be able to perform more than 100 different chemistry, immunoassay and infectious disease assays on a single, high-quality system. In addition to its current broad menu including user-defined applications, the Vitros 5600 Integrated system will have the capability to run future tests for earlier detection of diseases. Commercial availability is expected in 4Q08. The integrated system uses market-proven Vitros technologies into one of the easiest to use and most compact systems on the market. The platform is designed to meet the centralized testing needs of customers managing skilled labor shortages, budget restrictions and increasing test volumes. One of its innovations is the "Sample-Centered" processing approach, where each individual sample is accessed independently and in parallel for chemistry and immunoassay testing.

• NanoVibronix (Nesher, Israel) said FDA has granted 510(k) clearance to market PainShield MD, a diathermy device used to treat pain. The company says PainShield is the first hands-free, patch-based diathermy device, thus allowing for "an entirely new dimension in ultrasound treatment of pain and soft-tissue healing." PainShield consists of a disposable patch connected to a portable reusable driver and generates ultrasound waves to the desired area of the body.

• Stereotaxis (St. Louis) said it is now selling the Odyssey Cinema system, a data management solution for remote viewing and recording of live interventional cases. Odyssey Cinema enables physicians to remotely view real-time high-definition images of a procedure. It includes an archiving capability that will allow clinicians to store and replay entire procedures or segments of procedures. The Odyssey portfolio of products consolidates the systems in an electrophysiology lab, improving the ergonomics for physicians and increasing their focus on critical patient information. The company said interventional physicians typically are faced with the challenge of interacting simultaneously with multiple systems and diverse sources of diagnostic and imaging information during a procedure. Odyssey consolidates all of these sources of information into a single, manageable format, "dramatically simplifying the interventional lab and potentially bringing greater simplicity and efficiency to electrophysiology procedures," Stereotaxis said.