Duet™ System

04/07

BioView Ltd. (Rehovot, Israel)announced FDA clearance to market its automated scanning microscope and image analysis system, the Duet™ System, to detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalinfixed, paraffin embedded human breast cancer tissue specimens, probed with the Vysis PathVysion™ Her-2 DNA Probe Kit.

MuGard™

04/07

Access Pharmaceuticals, Inc. (Dallas, Tex.) has received FDA 510(k) clearance to market MuGard™ in the U.S. MuGard is the company’s oral rinse product for the management of oral mucositis, the debilitation side-effect that affects more than 40 percent of cancer patients undergoing radiation and chemotherapy.

RPM™ Respiratory Gating System

04/07

Varian Medical Systems (Palo Alto, Calif.) has received FDA 510(k) clearance for patient position monitoring capabilities that have been added to the company’s RPM™ respiratory gating system, which is used to synchronize imaging and radiation therapy treatment with a patient’s respiratory cycle. The new feature in Varian’s RPM system detects any motion that compromises the accuracy of the treatment.

oncoFISH™ Bladder Diagnostic Application

04/07

Ikonisys Inc., (New Haven, Conn.) announced FDA clearance to market the company’s oncoFISH™ bladder diagnostic application in the United States. In conjunction with the company’s Ikoniscope® robotic digital microscopy platform, oncoFISH bladder enables automated testing of cells found in urine specimens to aid in the detection of bladder cancer.

CellSearch™ Circulating Tumor Cell Kit

04/07

Immunicon Corporation (Huntingdon Valley, Pa.) announced that Veridex, LLC, a Johnson & Johnson company, has received FDA clearance for the CellSearch™ Circulating Tumor Cell Kit as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for circulating tumor cell (CTC) count should be used in conjunction with other clinical methods for monitoring breast cancer. A CTC count of 5 or more per 7.5 mL of blood at any time during the course of the disease is predictive of shorter progression-free survival and overall survival.