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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 October 2006
Bio-Rad Laboratories acquired Blackhawk BioSystems, manufacturer of quality control products for use in laboratories that perform infectious disease testing procedures. The terms of the acquisition were not disclosed. Bio-Rad and Ciphergen entered into an agreement whereby Bio-Rad will acquire and manufacture, sell and market the Surface Enhanced Laser Desorption/Ionization (SELDI) technology to the life sciences market for proteomics applications that include biomarker discovery, characterization and validation. Ciphergen will retain exclusive rights to the diagnostics market. Dako received FDA clearance to market its EGFR pharmDx kit, to be used to assess patient eligibility for treatment with Vectibix. The test was approved simultaneously with approval for Vectibix (panitumumab), manufactured by Amgen. Vectibix is indicated for treatment of patients with EGFR-expressing colorectal cancer. Epocal received FDA clearance to market its first product, the EPOC Enterprise Point of Care Blood Analysis System. The system is a blood analyzer that performs a panel of critical care tests. The product features smart-card-like diagnostic test cards and a portable PDA analyzer with wireless connectivity to the hospital information system. HemoSense has an agreement with CheckUps, a provider of retail-based, non-emergency, walk-in medical facilities, to supply its INRatio PT/INR testing system to all CheckUps medical clinics located in Wal-Mart stores, including 20 new clinics scheduled to open in the southeast by the end of 2006. Immunotope was awarded a Phase II SBIR contract from the U.S. Army to develop a prostate cancer screen based on the detection of prostate cancer-specific autoantibodies produced in an immune response that is stimulated by the earliest presence of cancer. Inverness Medical Innovations, Chembio Diagnostics, and StatSure Diagnostic Systems entered into a series of agreements that provide Inverness with exclusive worldwide marketing rights to Chembio's FDA-cleared, point of care, rapid test for the detection of antibodies to HIV. The test utilizes Inverness' proprietary lateral flow technology and StatSure's patented barrel technology. In addition, Inverness obtains exclusive U.S. marketing rights to Chembio's proprietary lateral flow cassette test (HIV 1/2 STAT PAK). International Technidyne Corporation (ITC) acquired A-VOX Systems, a manufacturer of POC CO-Oximetry test devices. ITC has acquired all of the outstanding shares of Avox for approximately $9 million in cash. Lumera announced an expanded collaboration agreement with the Institute for Systems Biology (ISB) to develop an array of cancer biomarkers based on Lumera's ProteomicProcessor instrument and ISB’s NanoCapture chips. Luminex introduced its first diagnostic test on the xMAP platform, the Luminex Pneumococcal Assay. The assay has been designed to multiplex the fourteen commonly requested serotypes in a single reaction. OraSure and Roche agreed to jointly develop fully automated drug tests using saliva. The tests would use OraSure's Intercept saliva collection device and Roche Diagnostics' microparticle analysis technology. Phadia USA received FDA clearance to market its EliA CCP, a fully automated assay for the measurement of cyclic citrullinated peptide (CCP) antibodies, a biomarker for rheumatoid arthritis.
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