• A study published in the British Journal of Urology International showed that Advanced Medical Diagnostics’ (Waterloo, Belgium) HistoScanning technology had high accuracy in the characterization and localization of prostate cancer foci, according to the company. HistoScanning is a diagnosis support tool designed to detect, visualize and characterize cancers in solid organs. It is used in conjunction with specific commercially available ultrasound systems capable of acquiring and transferring so called volumetric radio frequency data. The tissue characterization algorithms can either be applied to discrete regions of interest or the entire scanned tissue volume. Suspicious areas are highlighted in HistoScanning’s 3-D image viewer.

• AMDL (Tustin, California) said that it has filed with the FDA for clearance to market its DR-70 (FDP) ELISA tumor marker test for use as an aid in monitoring patients previously diagnosed with colorectal cancer. AMDL’s DR-70 (FDP) ELISA is an in vitro diagnostic test for the DR-70 (FDP) antigen in human serum. When cleared to market by the FDA, it will be used as an aid in monitoring the disease status in patients who have been previously diagnosed with colorectal cancer. AMDL said it believes that the test will be useful as an aid in monitoring cancer patients throughout the course of the disease, including after primary surgery, and in determining the response to therapy. AMDL makes tests for the early detection of cancer.

• Instrumentation Laboratory (Lexington, Massachusetts) reported receiving FDA clearance to expand the intended use for HemosIL D-Dimer HS to exclude venous thromboembolism (VTE) in outpatients suspected of deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability assessment model. HemosIL D-Dimer HS features expanded working range, high analytical sensitivity, virtually no interference from rheumatoid factor and minimal optical interference from hemoglobin, lipemia and bilirubin. It is automated on the ACL TOP system with time to results in less than five minutes. Instrumentation Laboratory makes in vitro diagnostic instruments.

• Nanosphere (Orthbrook, Illinois) said it has received clearance from the FDA for the Verigene F5 / F2 / MTHFR nucleic acid test, which detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12). This marks the second nanotechnology-based assay cleared by the FDA to run on the Verigene system, following clearance in September of the company’s Verigene warfarin metabolism nucleic acid test. The test is the first FDA-cleared test for the identification of mutations in three specific genes that together can increase an individual’s risk for dangerous blood clots and their leading complication, stroke. The test is available in single- and multi-target (multiplex) formats, allowing users to select the test cartridge that best fits the clinical indications for testing. Nanosphere is a nanotechnology-based molecular diagnostics company.

• Novadaq Technologies (Toronto) said that it will launch the PINPOINT endoscopic imaging system at the annual meeting of American College of Chest Physicians, CHEST 2007. PINPOINT is based upon the endoscopic technology Novadaq acquired from Xillix Technologies, and is designed to not only perform white-light bronchoscopy, but also the more clinically relevant imaging commonly referred to as autofluorescence and narrow-band imaging. The company said many studies have shown autofluorescence to be more effective in the detection and localization of central airway cancers than conventional white-light bronchoscopy. Novadaq makes medical imaging systems.