• Roche Diagnostics (Basel, Switzerland) reported introducing an advancement in point-of-care (POC) anticoagulation monitoring, the CoaguChek XS system, for physician's office use and self-testing by patients on warfarin therapy. The product offers benefits that for managing manage in-office prothrombin time (PT/INR) testing more effectively. The company says CoaguCheck XS is the only anticoagulation monitoring system to perform onboard quality control in the reagent chamber and also neutralizes therapeutic levels of heparin and LMW heparin. Performing PT/INR (clotting time) testing POC rather than at an outside lab enables dosage adjustments to avoid serious complications. Roche is a healthcare group in the fields of pharmaceuticals and diagnostics.

• Zimmer Holdings (Warsaw Indiana) and ISTO Technologies (St. Louis) reported that the clinical trial is now underway for Neocartilage, a tissue-engineered graft under investigation for the restoration of cartilage defects, reestablishment of joint function and relief of pain in the knee. The product will be marketed as DeNovo ET. The product is a tissue graft grown from juvenile chondrocytes (cartilage cells) using ISTO's cell-based technology. The companies said that studies have demonstrated that juvenile chondrocytes produce cartilage significantly better than their adult counterparts. Cartilage works as a low friction articulating surface to protect joints from wear and tear experienced during motion. Cartilage is known to have limited capacity to heal on its own. Most joint replacements are performed as a result of the effects of osteoarthritis. Zimmer makes reconstructive and spinal implants, trauma and related orthopedic surgical products. ISTO is an orthobiologic company.

• ZymoGenetics (Seattle) said that the biologics license application for recombinant human thrombin (rhThrombin) has been accepted for review by the FDA. ZymoGenetics is developing rhThrombin, a recombinant form of human thrombin that is not derived from animal or human blood, as an aid to controlling bleeding during surgery. Thrombin is used in more than 1 million surgeries each year in the U.S. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins and in some cases these antibodies appear to be related to serious bleeding complications. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand. ZymoGenetics makes protein drugs.