• BioCurex (Richmond, British Columbia), which is developing products for cancer diagnosis, imaging and therapy, reported that its Recaf blood test for cancer is able to detect very early stages of breast cancer with a high degree of accuracy. In a blinded study vs. normal patient samples, the test showed a 90% sensitivity and 100% specificity in 42 samples of Stage I cancer. In Stage II cancer, the test showed a 93% sensitivity and 100% specificity in 45 samples.
• Bostwick Laboratories (Richmond, Virginia), a diagnostic testing and information reference laboratory focused on urologic diseases, said the first selenium test that predicts prostate cancer risk, SeleniumHealth, is now available from the company under license from the Gerald P. Murphy Cancer Foundation. A man simply trims one or more toenails and submits the clippings for selenium content, which may predict the risk of a man's prostate cancer.
• Immucor (Norcross, Georgia), a provider of automated instrument-reagent systems to the blood transfusion industry, reported that the FDA has cleared the company's Capture-S and CMV Assays for use on the Galileo instrument. Galileo is Immucor's fully automated walk-away instrument for the hospital blood bank transfusion laboratory, donor centers and reference laboratories.
• NxStage Medical (Lawrence, Massachusetts), a manufacturer of systems for the treatment of end-stage renal disease and acute kidney failure, reported that it has received FDA 510(k) clearance to market its PureFlow SL product and its first clinical use. The first-generation device prepares high purity dialysate from ordinary tap water in the dialysis patient's home, designed to help patients with end-stage renal disease more conveniently and effectively manage their home hemodialysis therapy by eliminating the need for bagged fluids. The NxStage PureFlow SL is an accessory to the NxStage System One designed to automatically prepare ultra pure water from ordinary tap water, and mix this water with concentrate to produce high purity dialysate.