• Biocept (San Diego) will launch I.D. Rh(D), a series of noninvasive prenatal diagnostic tests that can be performed with a simple maternal blood sample, at the annual clinical meeting of the American College of Obstetricians and Gynecologists. The I.D.Rh(D) test diagnoses the Rh(D) status of a fetus in an Rh(D) negative pregnancy, and can be performed as early as ten weeks of gestation. The test isolates fetal DNA circulating in the mother's whole blood, using Biocept's I.D. (Isolating Fetal DNA) platform technology. The fetal DNA is analyzed in Biocept's CLIA-accredited clinical laboratory to determine Rh(D) genotype. Similar noninvasive tests have been available routinely in some countries outside the U.S. Biocept says that I.D.Rh(D) is the only fetal Rh(D) diagnostic that identifies fetal DNA in maternal blood in all cases in which a diagnosis can be delivered-whether the fetus is male or female, Rh(D) negative or positive. This eliminates the uncertainty that can occur with other tests in which an Rh(D) negative female fetus cannot be definitively identified from the maternal blood sample. Biocept specializes in diagnostic assays.
• Health Discovery (HDC; Savannah, Georgia) reported clinical trial results for HDC's new molecular diagnostic test for prostate cancer, licensed exclusively to Clarient. The initial clinical validation study completed recently by Clarient from prostate tissues obtained in collaboration with M.D. Anderson Cancer Center demonstrated a high success rate for identifying the presence of Grade 3 or higher prostate cancer cells (clinically significant cancer) in prostate cancer tissue. HDC said the test also demonstrated a high success rate for correctly identifying those prostate specimens that did not have prostate cancer as being negative for prostate cancer and achieved a specificity of 80% for identifying the non-cancer tissues, which included normal and benign prostatic hypertrophy tissue, as not having genomic evidence of cancer. HDC and Clarient now will move to Phase II of the clinical trial process to increase the number of specimens tested in order to achieve the statistical significance necessary to validate these successful initial results. Health Discovery specializes in pattern recognition technology.
• Nipro Diabetes (Miramar, Florida) introduced the Amigo insulin pump. The pump helps control blood glucose for children and adults with types 1 and 2 diabetes. The Amigo is user friendly with computer-like help screens for easy programming. The pump mimics the pancreas by consistently delivering basal insulin throughout the day and night and allowing the wearer to program bolus insulin whenever needed. It uses rapid-acting insulin that is very similar to the insulin produced by the human pancreas. The Amigo is also a smart pump because it is capable of calculating bolus insulin for food and high blood glucose readings through parameters prescribed by the physician and stored in the pump. Nipro makes diabetes products and supplies.
• TAH Industries (Robbinsville, New Jersey) reported the introduction of the u-TAH Nano system, a single-use packaging and applicator system to use the mechanical, ergonomic, and economic benefits of standard single-component dispensers for mixing and applying two-component adhesives, pastes and other dental and medical materials in clinical applications. Potential applications for the u-TAH Nano system include packaging, mixing and applying a wide range of two-component materials such as self-cure and dual-cure dental materials, surgical sealants and adhesives, audiology impression materials, and orthopedic cements. TAH Industries makes disposable plastic mixers and cartridge-dispensing systems, meter-mix dispense valves and accessories.