• AFP Imaging (Elmsford, New York) said it has begun the delivery and installation of the new model VG (vertical generation) Cone Beam CT X-ray scanners (CBCT) to dentists in the U.S., Canada and Europe. AFP recently received regulatory clearance from the FDA, Health Canada and the CE agencies for this new model. VG allows the patient to stand, sit or stay in a wheel chair while they are scanned in an upright, vertical position, using a conical beam of X-rays that passes around the head, allowing the capture of a three dimensional, digital radiographic image of the patient's teeth and jaw structures. The company's technology includes software to capture and quickly display these detailed images. 3-D applications are vital for orthodontics, implants and oral surgery, among others, where complex cases require sophisticated imaging to plan the treatment procedure.
  • Agendia (Amsterdam, The Netherland) said its MammaPrint breast cancer prognosis test was shown to be a valuable tool to assess risk of breast cancer recurrence also in postmenopausal breast cancer patients. Data recently presented at the AACR/NCI/ EORTC conference "Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications" in San Francisco showed that MammaPrint is a valuable tool to assess risk of breast cancer recurrence in older age breast cancer patients as well. To date, MammaPrint has received two clearances from the FDA for its test, one for safety and effectiveness under the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) Guidelines for use in breast cancer prognosis and another for the test in conjunction with RNARetain, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling.
  • GeneNews (Toronto), a company focused on developing simple blood-based molecular diagnostic tests for the early detection of diseases and personalized health management, said it has started collecting patient samples for clinical validation studies of its lead product under development, ColonSentry. In June 2006, GeneNews presented training set results at the American Society of Clinical Oncology Annual Meeting which demonstrated that the expression profile of five genes in patients with colorectal cancer could be differentiated from controls. Blood RNA samples from an Asian population were profiled to identify differentially expressed genes. This analysis yielded a combination of five genes that achieved sensitivity of 90% and specificity of 79% in the training set.
  • InSightec (Tirat Carmel, Israel) reported FDA approval of an investigational device exemptions allowing the company to launch a Phase III pivotal study to determine if its ExAblate incisionless surgery system can safely and effectively reduce the pain associated with bone metastases in patients who have failed to respond to radiation therapy. The non-invasive, ionized radiation-free magnetic resonance-guided focused ultrasound (MRgFUS) system was approved to treat women suffering from symptomatic uterine fibroids in 2004. Over 3,500 women have already undergone treatment with ExAblate worldwide. Bone is the third most common tissue to which cancer spreads, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases and in breast cancer, bone is the second most common site of metastatic spread, affecting 90% of patients with progressive breast cancer. Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.
  • Lifeline Biotechnologies (Reno, Nevada) said it has recently provided patient cases to Nanyang Technical University to aid in the development of the First Warning System's (FWS) interpretive analytical system. One objective is to make it more user friendly for women to assist in the detection of breast cancer. Originally, the FWS was worn by women for 48 hours, with eight sensors on each breast. This length of time caused issues because the longer the testing period, the more the likelihood women would accidentally loosen a sensor and send faulty data. After analyzing the patient cases, Lifeline, along with the work at Nanyang Technical University, said it has been working to reduce the testing period to 24 hours or less.

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