• Aspect Medical Systems (Norwood, Massachusetts) reported interim study results from the Biomarkers for Rapid Identification of Treatment Effectiveness (BRITE) trial in major depression were presented at the annual meeting of the American Psychiatric Association in San Diego. Interim findings from BRITE suggest that Aspect’s EEG-based research technology is a significant predictor of patient response to treatment of depression with a selective serotonin reuptake inhibitor (SSRI) after one week of treatment. Further, the study results suggest that the technology may help expedite the process of identifying effective antidepressant drug therapy. Aspect specializes in the development of technology to monitor brain activity.
ease, as compared to those without such findings. Prostascint is a monoclonal antibody-based agent that targets prostate-specific membrane antigen (PSMA) to image the extent and spread of prostate cancer. Prostascint consists of Cytogen’s PSMA-targeting monoclonal antibody, 7E11-C5, linked to the imaging radioisotope Indium-111. By targeting PSMA, the Prostascint molecular imaging procedure can detect the extent and spread of prostate cancer using a standard gamma camera. Cytogen is a pharmaceutical company specializing in oncology products.
* Luna Innovations (Roanoke, Virginia) said that it received FDA 510(k) clearance for its EDAC (emboli detection and classification) Quantifier, a cardiopulmonary bubble detector that uses quantitative ultrasound technology to non-invasively detect gaseous emboli in an extracorporeal bypass circuit line. Emboli can be air bubbles or solid matter, variable in their size and consistency, and can enter the extracorporeal blood circuit during invasive medical procedures such as cardiopulmonary bypass surgery. The Quantifier simultaneously monitors up to three bypass circuit locations, provides count rates up to at least 1,000 per second and detects emboli as small as 10 microns in diameter. The blood circuit monitor also provides real-time feedback and archived data on information such as emboli counts and volume estimates. Luna makes products for the healthcare, telecommunications, energy and defense markets.
* VirtualScopics (Rochester, New York) reported release of its next-generation 2.0 software platform for the use of imaging in clinical trials. This platform provides FDA-required 21 CFR Part 11 compliant tools for managing international imaging sites. The software platform includes a new image analysis automation system, improved traceability, enhanced tools for data management, in addition to real-time detailed reports for VirtualScopics’ customers. VirtualScopics makes image-based biomarker solutions.