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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 February 2005
Abbott Diagnostics entered into a licensing agreement with The Cleveland Clinic for the development of an automated in vitro diagnostic test to detect myeloperoxidase (MPO), an enzyme found in white blood cells. Detecting elevated, circulating levels of MPO may be useful in determining a person's risk for adverse cardiac events such as a heart attack. Abbott also entered into an agreement with Nihon Kohden Corporation for the commercialization of automated hematology diagnostic instruments for use in hospital laboratories and physician offices. Two 5-part differential hematology instruments will be manufactured by Nihon Kohden and distributed by Abbott under the CELL-DYN Pearl brand name. Abbott obtains exclusive distribution rights for the two instruments in the United States and Canada and non-exclusive distribution rights for the instruments in other countries with the exception of China and Japan. Biomerica, Inc. launched a test to measure levels of C-peptide in blood. Measurement of C-peptide levels allows clinicians to differentiate between Type I and Type II diabetes and may be to indicate the need for progression to insulin therapy in Type II diabetes. BRAHMS Ag received FDA clearance to market the BRAHMS PCT-LIA to detect sepsis biomarker, procalcitonin. The PCT-LIA is a manual assay that uses a luminometer, Brahms also makes a semi-quantitative, rapid version of the assay, PCT Q, which is currently available for research purposes in the U.S., but will be submitted to the FDA for review this year. Chembio Diagnostics, Inc., entered into a license and technology transfer agreement with Prionics AG. The agreement grants an exclusive license for Prionics to use Chembio's technology in the manufacturing of the Prionics Check PrioSTRIP, a rapid test for the detection of BSE. ChromaVision Medical Systems changed the name of the corporation to Clarient, Inc. The company will be organized into three business units -- diagnostic services, which provides a full range of onsite and remote advanced cancer diagnostic testing; biopharmaceutical services, which provides technology and expertise to leading drug companies in pursuit of a new generation of targeted cancer therapies; and the company's legacy imaging equipment product line. Ciphergen Diagnostics signed a research and license agreement with The University of Texas M. D. Anderson Cancer Center to utilize Ciphergen's ProteinChip System and associated bioinformatics suites to further their ongoing research in ovarian cancer. Ciphergen will analyze clinical samples provided by M. D. Anderson for ovarian cancer using its Deep Proteome and Pattern Track suite of proteomics tools. Ciphergen has exclusive rights to license discoveries made during the course of this collaboration. Clinical Data, Inc. entered into a distribution agreement with Daiichi Pure Chemicals Co., Ltd. to distribute Daiichi's PSA test. Daiichi's assay technology allows PSA to be measured on Clinical Data's existing line of clinical chemistry analyzers and on most conventional clinical chemistry systems currently in use around the world. GlucoLight Corporation is developing a non-invasive glucose sensor that can be used as a continuous monitor in a hospital setting and eventually as a portable monitor for use by diabetics. GlucoLight's uScatter (microscatter) technology is based on patented technologies in the area of Optical Coherence Tomography (OCT) and Low Coherence Interferometry (LCI). uScatter measures the scatter of light from cells to determine glucose levels in the interstitial fluid. HemoGenix Inc. and Biotrin International Ltd. have developed the OxyFLOW Research Kit, a flow cytometry assay for detecting and quantifying oxidative DNA damage to lympho- hematopoietic cells as a result of stress, xenobiotics and the administration of drugs. Inverness Medical Innovations, Inc. signed a definitive agreement to acquire Binax, Inc., manufacturer of rapid diagnostic products for infectious disease testing, primarily related to the respiratory system. Inverness has also acquired Ischemia Technologies, Inc. Ischemia developed the only FDA-cleared in vitro diagnostic test specifically targeted on cardiac ischemia, known as Ischemia Modified Albumin (IMA).
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