Pharmacy & Therapeutics - March 2009 - (Page 137) NEW DRUGS NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Vitros 3600 Immunodiagnostic System Manufacturer: Ortho Clinical Diagnostics/J&J, Rochester, N.Y. Approval Date: December 26, 2008 Use Classification: Three Vitros technologies are combined into a single system that is designed to produce highly accurate test results. Description: The MicroWell technology with its enhanced chemiluminescence enables assays to be performed with small sample volume requirements to test for many diseases. The MicroSensor Technology automatically performs sample quality checks, thereby reducing the time, labor, and the potential for errors associated with manual interpretation. Intellicheck Technology verifies performance and reduces the potential for errors by providing real-time operator notification and tracking. The device extends the capabilities of Vitros instruments and uses the same reagents as other Vitros systems to maintain accuracy and efficiency. Purpose: This high-capacity system delivers dependable results by offering a comprehensive immunoassay so that laboratories can address challenges of quality, labor, and cost. A menu of 47 immunoassays covers cardiology, oncology, endocrinology, infectious diseases, thyroid disorders, metabolic conditions, and anemia. The Troponin I ES Assay provides improved sensitivity and reliable information for patients with acute coronary syndrome, and the anti–hepatitis C virus (HCV) assay is used to detect immunoglobulin G antibody to the virus. Benefit: Diagnostic laboratories are faced with the challenge of decreasing the turnaround time needed to provide accurate test results to clinicians. The advantages of processing speed, onboard reagent capacities, and uninter- DRUG NEWS Minn. Approval Date: January 19, 2009 Use Classification: PrepaCyte-CB provides public and private cord blood banks with a simple and cost-effective method of processing umbilical cord blood to obtain potentially therapeutic cells for eventual transplantation in humans. These include total nucleated cells and CD34-positive hematopoietic stem cells and progenitor cells. Description: In a multisite in vitro clinical study, the system recovered high yields of total nucleated cells, mononucleated cells, and CD3-positive hematopoietic stem cells and progenitor cells from human umbilical cord blood. The device removes approximately 99% of red blood cells from the final processed cord blood unit, maximizing cryopreser vation space and reducing potential problems of ABO incompatibility. The desired total nucleated cells and stem cells remain unmodified during processing. The device is integrated with Stemsoft Software’s StemLab to record, track, and manage all cell-processing and storage data. Purpose: With the greater demand and rapid growth for cord blood utilization for transplantation, PrepaCyte-CB offers an opportunity to improve the quality of cord blood units. Benefit: The device is intuitive and easy to use, and it can be quickly implemented within new and existing cord blood banks. Batch processing and hands-on staf f time are reduced. No costly capital equipment or maintenance fees are required; only a standard laboratory centrifuge is necessary to concentrate desired cells after separation. During a clinical study, the benefits of PrepaCyte-CB were so readily apparent that it was an easy decision to switch to this new processing platform. The device helps to control costs, saves time, and consistently obtains high-quality cord continued on page 141 Vol. 34 No. 3 • March 2009 • rupted workflow allow laboratories to address peak workloads and decrease turnaround times. Users can increase productivity while maintaining high-quality results. The large capacity of 31 reagent packs and the ability to change reagents obviates the need for interruptions in workflow. Single-use tips eliminate sample and reagent carryover and detect clots and bubbles, thereby avoiding the reporting of erroneous results. The system can be easily integrated with the enGen Laboratory Automation System and other Vitros systems, allowing users to expand or alter modules and interfaces as needs change. There are no water or drainage requirements. The device can meet the high-volume testing needs of clients managing skilled labor shortages and budget restrictions. Source: Medical News Today, www. medicalnewstoday.com/articles/134059. php Name: RapidSense Methamphetamine Test Manufacturer: QuantRx Biomedical Corporation, Doylestown, Pa. Approval Date: January 8, 2008 Use Classification: This drug-ofabuse test is based on the company’s core intellectual property related to lateral flow techniques for consumers and health care professionals. Description: The one-step, positiveread test is designed for use in professional markets. Purpose: Clients can test for drugs of abuse. Benefit: The test is based solely on proprietary technology approved by the FDA. Source: www.medicalnewstoday. com/articles/134797.php Name: PrepaCyte-CB Processing System Manufacturer: BioE, Inc., St. Paul, P&T® 137 http://www.medicalnewstoday.com/articles/134059.php http://www.medicalnewstoday.com/articles/134059.php http://www.medicalnewstoday.com/articles/134797.php http://www.medicalnewstoday.com/articles/134797.php
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