• Cylex (Columbia, Maryland) reported the publication of an independent, peer-reviewed, clinical research study in which the level of cellular immune response measured prior to kidney transplantation using the company’s ImmuKnow immune cell function test was found to identify patients that may be at risk for early acute transplant rejection and unstable kidney function in the first three months following transplantation. Cylex’s ImmuKnow immune cell function assay detects cell-mediated immunity by measuring the concentration of ATP from CD4+ cells following stimulation. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population. Cylex is a life science company that develops and manufactures research and in vitro diagnostic products that are intended to illuminate immunity.

• Fujifilm Medical Systems USA’s (Stamford, Connecticut) reported that its computed radiography for mammography (FCRm) is now available for use in mobile mammography environments. The first two installations of Mobile FCRm systems were in mobile units operated by the Harris County Hospital District in Houston and St. Joseph’s Hospital of Atlanta. Mobile FCRm works with existing x-ray equipment, uses standard 110v power, and does not require special environmental control. Fujifilm Medical makes full field digital mammography systems.

• Gen-Probe Incorporated (San Diego) has submitted to the FDA a supplemental regulatory application for the additional use of the Procleix Ultrio assay to screen donated blood for the hepatitis B virus (HBV). The FDA approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006. Gen-Probe is seeking approval to use the assay to screen for HBV on both its semi-automated instrument platform and the Tigris system. Gen-Probe Incorporated makes nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.

• Hologic (Bedford, Massachusetts) reported the publication of a study evaluating the Hologic MammoSite radiation therapy system (RTS), one, two and three years after treatment. The authors note that the RTS is “logistically simpler, technically more reproducible, and patient ‘friendly’” than other interstitial brachytherapy devices. The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (the surgical removal of a breast tumor). MammoSite RTS delivers radiation from inside the lumpectomy cavity over a course of five days. The device targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Hologic specializes in imaging systems, diagnostics and interventional devices for women.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported that Yale University (New Haven, Connecticut) has released the results of its Phase II study on a blood test to detect early stage ovarian cancer. Using six biomarkers, this blood test can discriminate between disease-free women and ovarian cancer patients (stage I-IV) with high specificity (99.4%) and sensitivity (95.3%). Initial studies are focused on women who have increased risk for the development of ovarian cancer. Ovarian cancer is the fifth leading cause of cancer-related deaths in women in the U.S. and is the leading cause of gynecologic cancer deaths. LabCorp specializes in developing diagnostic technologies.

• Nutra Pharma (Boca Raton, Florida) said that its wholly owned medical devices subsidiary, Designer Diagnostics, has started marketing what it said is the first-ever environmental test kit for the detection of nontuberculous mycobacteria (NTM) in water and soil. NTM, also known as atypical tuberculosis (Atypical TB) or mycobacterium other than tuberculosis (MOTT), is a bacteria that is found in a multitude of environments - in the soil, in some domestic and wild animals, and perhaps most importantly, in water, including showers and hot tubs. One of the most common forms of NTM infections found in humans is Mycobacterium avium complex (MAC). This is a primary cause of respiratory disease in humans and is a leading cause of death in HIV/AIDS patients. Nutra Pharma is a biotechnology company that is developing drugs for HIV and multiple sclerosis

• QuantRx Biomedical (Doylestown, Pennsylvania) said that David Elmaleh, chairman and chief scientific founder of FluoroPharma, will present findings from the company’s Phase I trial for CardioPET, a metabolic cardiac imaging agent for the assessment of coronary artery disease. The trial was a single-center, open-label study, designed to evaluate safety, dosimetry, and pharmacokinetics of CardioPET as a PET tracer for myocardial imaging. Fifteen normal healthy volunteers and six CAD patients participated in the Phase I trial. FluoroPharma is a molecular imaging company engaged in the discovery and development of products for the PET market. QuantRx Biomedical is a diagnostics company that makes products based on its technology platforms.