The following is a review of diagnostic product developments worldwideThe information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.
The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.
Product developments in January 2005
BD Diagnostics has received FDA clearance to market the BBL CHROMagar MRSA culture medium. BBL CHROMagar MRSA allows for the direct detection and identification of most MRSA within 24 hours.
Beckman Coulter, Inc. and Critical Therapeutics, Inc. signed an exclusive license agreement under which Critical Therapeutics has granted Beckman Coulter a license for its High Mobility Group Box Protein 1 (HMGB1) technology. Beckman Coulter intends to use the HMGB1 technology to develop an immunoassay for detection and management of inflammatory diseases. HMGB1 belongs to a class of proteins called pro-inflammatory cytokines and is secreted by the immune system as part of the body's response to trauma and infection.
Bio-Rad Laboratories, Inc. received FDA clearance to market its BioPlex 2200 system, immunoassay platform that uses multiplexing technology to analyze for multiple disease states from single patient samples. Bio-Rad has also received FDA clearance to market its Multispot HIV-1/HIV-2 Rapid Test for the detection and differentiation of HIV-1 and HIV-2 antibodies".
Grant Life Sciences entered into a memorandum of understanding (MOU) with AccuDx Corp. for the exclusive rights to AccuDx's rapid tests for HIV-1, HIV-2, and Dengue Fever, as well as AccuDx's proprietary colloidal gold reagent. The MOU also proposes to establish the right for Grant Life Sciences to manufacture these products in AccuDx's contract manufacturing facility in Tijuana, Mexico.
Insulet Corporation received FDA clearance to market its OmniPod Insulin Management System that offers continuous subcutaneous insulin delivery and blood glucose monitoring. The System will be available by prescription in 2005. The pod is worn on the skin beneath the clothing, and delivers insulin according to pre-programmed instructions from the wireless, handheld PDM. Once the OmniPod is programmed, the PDM is used to check blood glucose levels, give bolus dosages, and adjust basal rates.
Meridian Bioscience, Inc. completed the purchase of O.E.M. Concepts, Inc. O.E.M.'s products will be added to Meridian's Viral Antigens and BIODESIGN International subsidiaries for the life sciences market.
Molecular Devices Corporation launched its QBT Fatty Acid Uptake Assay Kit, an homogenous immunoassay for fatty acid uptake for use in high- throughput screening and metabolic disease research. Defects in fatty acid metabolism have been linked to several pathological states, including insulin desensitization, Type 2 diabetes, obesity and cardiovascular disease.
NTD Labs offers Ultra-Screen Instant Risk Assessment (IRA) at-home blood test. The patient uses an in-home blood specimen collection system and sends her dried blood card directly to NTD Laboratories as early as nine weeks of pregnancy. The blood specimen is analyzed for free Beta human chorionic gonadotropin (free Beta), and pregnancy associated plasma protein-A (PAPP-A).
Quest Diagnostics Incorporated received an exclusive license from The University of Texas M. D. Anderson Cancer Center for the use of five proprietary blood testing methods for the diagnosis, treatment and monitoring of leukemia and lymphoma in cancer patients. The tests are designed to detect proteins that are expressed on the surface of tumor cells, as well as molecular targets from the tumor cells.
Spectral Diagnostics Inc. launched its i-Lynx connectivity solution that is made up of two interfaced components; a handheld electronic device to capture and analyze an image from the current Cardiac STATus rapid test strip, and a local area network (LAN) compatible docking station to automate data capture and communication.
Product developments - December 2004
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Last modified: February 3, 2005