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 Summer 2002
American Bio Medica Corp. and Hema Diagnostic Systems have signed a multiple-year contract manufacturing agreement for Rapid 1-2-3 HEMA, a POC test for HIV 1. The test will be manufactured and distributed at a low cost outside of North America. ABMC will manufacture the bulk test strips, a component of the Rapid 1-2-3 HEMA.
Bayer Corporation, Diagnostics Division has signed a definitive agreement to acquire Visible Genetics Inc. in a cash deal valued at $61.4 million.
Calypte Biomedical Corp. is developing a rapid urine-based screening test for HIV-1 antibodies.
Cepheid has been awarded a grant from the National Institutes of Health to develop rapid diagnostic tests for Mycobacteria tuberculosis.
Chiron Corporation has granted Abbott Laboratories a non-exclusive license for the research, development, and commercialization of small molecule therapeutics against certain hepatitis C virus drug targets contained in the HCV genome.
Cholestech Corp. has signed an agreement with Abbott Laboratories for the global distribution of the Cholestech GDX System for the determination of glycated hemoglobin. Under the terms of the agreement, Abbott will offer the Cholestech GDX system to physician offices and hospital-based customers both domestically and internationally.
Cygnus has received a supplemental pre-market approval (PMA) from the FDA for use of the GlucoWatch G2 Biographer in children and adolescents ages 7 to 17. The GlucoWatch G2 Biographer, made available September 2002, is the second-generation model of the GlucoWatch(R) Biographer system.
The merger of DAKO A/S and Cytomation, Inc. went into effect July 1, 2002. Cytomation focuses on flow cytometry instruments used for advanced cellular analysis.
Diametrics Medical, Inc. has introduced the GL cartridge for the measurement of glucose and electrolytes for the IRMA point-of-care system. Diametrics has also announced that Philips Medical Systems will not extend the current global exclusive distribution agreement between the two companies. The contract expires on October 31, 2002.
The Federal Trade Commission has voted to block Cytyc Corp's proposed acquisition of Digene Corporation.
Digene Corp. received another blow when Roche Diagnostics and the Institut Pasteur announced that Pasteur has assigned a broad portfolio of patents pertaining to the Human Papillomavirus (HPV) to Roche for an undisclosed sum. As part of the transaction, Institut Pasteur has assigned to Roche its rights to all cross license agreements concerning other HPV patents owned by others. This includes the cross license agreement by which Digene was granted a license under its U.S. and foreign patents relating to HPV types 35, 43 and 56 and has a license to U.S. and foreign patents relating to HPV types 33, 39 and 42. It does not include rights to Digene's intellectual property relating to HPV types 52, 58 and 68 or U.S. patent 5,057,411.
Further, Digene Corporation announced that it anticipates receiving a not approvable letter from the FDA for its Pre-Market Approval Supplement application to use TriPath Imaging's SurePath Test Pack as a specimen collection medium for Digene's Hybrid Capture HPV DNA Test.
Diagnostic Products Corp. has received FDA clearance to market the IMMULITE and IMMULITE 2000 hepatitis assays: two HBsAg & one HBsAg Confirmatory, two Anti-HBs, two Anti-HBc and two Anti-HBc IgM.
Disetronic Medical Systems, Inc. has launched insulin pump D- TRONplus together with InSight, DiaLog pump programming tool and a blood glucose meter. The devices form a diabetes management system that gives patients and doctors a comprehensive picture to date of a patient's therapy profile and specific needs. The InSight Diabetes Management Program is an Internet-based program that gives patients a timely, comprehensive picture of their diabetes-related information.
The Fred Hutchinson Cancer Research Center has received FDA clearance to market its Anti-SR protein antibody ELISA test, a new screening test for systemic lupus erythematosis.
Fujirebio Diagnostics, Inc. has granted Randox, Ltd., exclusive rights to develop and commercialize a tumor marker assay panel incorporating FDI's proprietary antibodies used in the CA125II, CA19-9, CA15-3, CA72-4 and Truquant BR Tumor Marker assays on Randox's Biochip Array Technology.
Gen-Probe Inc. has announced the spin-off of Gen-Probe from its parent company, Chugai Pharmaceutical Co., Ltd. has been approved for September 2002, in connection with the merger of Chugai and Nippon Roche, a subsidiary of Hoffmann-La Roche.
Hema Metrics Inc. has received FDA clearance to market the urea reduction ratio (URR) feature associated with the Crit-Line device. The URR technology provides for real-time URR based on changes in urea nitrogen concentration in the spent dialysate during hemodialysis.
Innotech USA, Inc. has received FDA clearance to its FriendlyLight LightLance Laser Skin-Perforator for blood sampling in hospital, office and home settings.
Inverness Medical Innovations, Inc. has acquired the Wampole Laboratories POC test business from MedPointe, Inc.
i-STAT Corporation has announced that on January 1, 2004, following the conclusion of its current marketing and distribution agreement with Abbott Laboratories, it will resume direct distribution of i-STAT products.
Luminex Corp has granted Celera Diagnostics worldwide, nonexclusive rights to develop and distribute in-vitro molecular diagnostic products based on Luminex's proprietary xMAP technology, for use on the Luminex 100 System.
Matritech Inc. has received FDA clearance to market its rapid POC NMP22 BladderChek, bladder cancer urine test.
Researchers at Rockefeller University have developed a urine test that measures how estrogen is transformed in the body to either promote or inhibit estrogen sensitive cancers. The test for measuring this estrogen metabolite ratio is available to the public at www.nubasix.com.
Opus Diagnostics Inc. has entered into an exclusive license agreement with Dainippon Pharmaceuticals Co., Ltd. to develop a diagnostic test to monitor blood levels of Zonisamide, an anti-epileptic drug. The license is for worldwide rights, except for Japan. Zonisamide is a drug developed by Dainippon and licensed in the United States and Europe to Elan Pharmaceuticals.
Quidel Corporation has launched the first two commercial applications of Quidel's patented LTF (Layered Thin Film) technology under the brand names, QuickVue Advance pH and Amines and QuickVue Advance G. vaginalis tests. Quidel has also introduced the UrinQuick Urine Chemistry Analyzer. The UrinQuick analyzer follows Quidel's August 2000 launch of QuickVue UrinChek urine test strips.
Research & Diagnostic Antibodies has been granted a US patent for a panel of monoclonal antibodies and immunoassays that detect human iNOS (inducible Nitric Oxide Synthase) that may be an important biochemical marker of sepsis, rheumatoid arthritis, and other diseases.
Roche Diagnostics has launched the Sysmex XT-2000i Automated Hematology Analyzer that offers Sysmex fluorescent flow cytometry. The system offers CBC, CBC plus differential, CBC plus reticulocyte, and CBC plus differential and reticulocyte modes and fluorescent platelet analysis.
Trinity Biotech plc has acquired the hemostasis division of Sigma Diagnostics from Sigma-Aldrich.
Ventana Medical Systems, Inc. has acquired a license for Molecular Diagnostics' In-Cell HPV assay, a bio-molecular assay for the detection of E6 and E7 proteins, to be performed and fully automated on the InPath Slide Based Test platform. In addition, Ventana will receive a license for the In-Cell HPV assay for use on Ventana's BenchMark Staining Platforms.
Product developments - June 2002
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Last modified: September 03, 2002