• Guardian Technologies International (Herndon, Virginia) reported the successful completion of a clinical study involving the evaluation of its signature mapping software solution product to an online database of mammographic X-ray exams known as the DDSM project. The study results are significant because no computer-aided detection technology has been able to assist radiologists in achieving such high levels of detection and with such low false-positive rates, the company said. The study showed that signature mapping achieved a 97.5% detection rate (sensitivity) on cancer cases, with just 2.5% false-negatives (cancer lesions undetected). On non-cancer cases, signature mapping accurately specified "no cancer" in 98.75% of the images, with a false-positive rate of just 1.25%. Guardian makes medical imaging and threat detection technology with applications for the healthcare and homeland security markets.

• Ivivi Technologies (Northvale, New Jersey) reported that it has completed enrollment in its clinical trial using the company's pulsed electromagnetic field (PEMF) technology to treat patients with ischemic cardiomyopathies. The institutional review board (IRB)-approved clinical trial at the Cleveland Clinic is designed for cardiac patients who are not candidates for surgical intervention such as angioplasty, stenting or cardiac bypass surgery. The trial looks at the use of Ivivi's PEMF technology over a period of five months on patients with ischemic cardiomyopathy, a heart condition characterized by decreased blood flow to the heart. The primary endpoint is the improvement in regional myocardial perfusion (the flow of blood through the heart) and function as seen with a 64-slice computed tomography (CT) Scan. The secondary endpoint is patient improvement for angina and exercise tolerance. Ivivi Technologies specializes in non-invasive electrotherapeutic technology.

• Predictive Biosciences (Lexington, Massachusetts) reported that results from a pilot study will be presented at the GTCBio's Rediscovering Biomarkers Conference, July 23-24 in San Diego. The results will be used to optimize tests detecting MMPs in urine to manage bladder cancer. The study assessed the impact of different sample collection methods on sensitivity and specificity of the MMPs as diagnostic biomarkers for bladder cancer. At a fixed protein level resulting in 90% sensitivity (detecting nine of 10 individuals with cancer), the optimal urine sample collection protocol significantly increased MMP-9 marker specificity, from about 74% (11 false positives of 42 disease-free individuals) to about 91% (five false-positives of 54 disease-free individuals). Predictive Biosciences is an emerging venture that makes diagnostic products for cancer management.

• Siemens Medical Solutions Diagnostics (Tarrytown, New York) reported the introduction of the ADVIA centaur cyclosporine (CsA) assay, an automated test offering laboratories a highly specific immunoassay for the cyclosporine A parent compound. The assay has a simplified extraction process and fully automated processing yielding an 18-minute turnaround time, the company said. The assay's linear range reduces the need for dilutions, reducing the time required for testing and the associated cost. The system features one-tube processing, reducing the need for pipetting, and delivers hundreds of test results per hour. Siemens Medical Solutions Diagnostics provides diagnostic solutions that assist in the diagnosis, monitoring and management of disease.