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.
Abbott Laboratories and i-STAT Corp have signed an agreement providing for a long-term sales, marketing and research alliance. The agreement calls for Abbott to assume sales and marketing responsibility for i-STAT's point-of-care blood analyzer while collaborating in the development of new products leveraging both i-STAT's and Abbott's technology. Abbott will take a minority equity position in i-STAT, acquiring 2,000,000 shares at $11.35 per share.
Affymetrix and Beckman Coulter will collaborate to commercialize DNA arrays under patents owned by or licensed to the two companies, including patents invented by Professor Edwin Southern of Oxford University (the "Southern Patents"). Under the agreements, Affymetrix and Beckman Coulter will cooperate to develop and commercialize GeneChip and other DNA probe arrays and related instrument systems for the bioresearch and diagnostic markets. In addition, the agreements anticipate cooperative arrangements that will provide others with access to this technology.
The University of Maryland and American Biogenetic Sciences have signed a collaborative agreement for the development of a diagnostic test for Human Herpes Virus Type 8 (HHV-8). The test may also be used as a means of predicting the development of Kaposi's Sarcoma allowing earlier treatment of the disease. HHV-8, the most recently identified member of the herpes family, is a blood-borne virus.
Axis Biochemicals has finalized two product versions of its patented technology for measuring homocysteine. A microtiter-version is being marketed by Bio-Rad Laboratories. The IMx-version is being marketed by Abbott Laboratories. Axis has applied FDA for 510K approval for both products. Axis also manufactures a %CDT product for diagnosing long term alcohol consumption which is distributed by Roche Boehringer Mannheim Diagnostics and Bio-Rad Laboratories.
Chronimed Inc. has received 510(k) clearance by the US FDA to market the Assure Blood Glucose Monitoring System, a diabetes testing product utilizing electrochemical biosensor technology.
Corgenix Medical Corp. has filed premarket notification 510(k) submissions to the US FDA for market clearance of three test kits to be used in the diagnosis and risk assessment of blood-clotting disorders. These tests detect human antibodies to B(2)-Glycoprotein I, which are regarded as more specific than other antibodies for thrombosis.
DiaSys Corp. has been awarded a technology patent for its system and method to microscopically analyze human feces for the presence of ovum, parasites and cysts. The company is commercializing the technology into a series of workstation products, the first of which has been released to market under the name FE-2. The company correlatively reported that it has been awarded a supplier's contract for the FE-2 by the General Services Administration (GSA) of the United States of America.
Digene Corp. has acquired Viropath BV, a Dutch company developing tests for human papillomavirus (HPV). Under the terms of a stock purchase agreement, Digene purchased all of the outstanding capital stock of Viropath in exchange for 181,884 shares of newly issued Digene common stock.
Diagnostic Products Corporation (DPC) has licensed from XOMA a patented technology that uses LBP (lipopolysaccharide binding protein) as a biochemical marker of systemic exposure to endotoxin, a potent bacterial poison that can trigger deadly infectious complications. DPC will initially use the technology to develop automated laboratory tests for the diagnosis and prognosis of diseases that are induced by exposure to endotoxin, such as sepsis and infectious complications of surgery and trauma. XOMA has already licensed the LBP assay technology to Biosite Diagnostics to make, use and sell point-of-care diagnostic products and has granted to SRL, a Japanese laboratory diagnostics company, a license to make, use and sell LBP diagnostics for central laboratories in Japan.
Endogen, Inc. has begun product shipment of Xplore mRNA Assays which are based on proprietary Invader technology, which generates rapid, linear signal amplification directly from mRNA molecules. Endogen entered into a product development and marketing agreement with Third Wave Technologies, Inc. in September 1997 to jointly develop this proprietary technology into mRNA assay kits for Endogen to commercialize worldwide. Endogen's assay kits are now available for measuring human cytokine mRNAs, including IL-1b, IL-6, TNFa and GAPDH.
Gamera Bioscience Corp. introduced the LabCD microfluidics-based platform technology and anticipates launching its first LabCD product targeted to the diagnostic community by year-end 1999. The LabCD System is a compact-disc based technology that integrates and automates microfluids with informatics. The LabCD utilizes a modified CD player and disposable compact discs and is being developed to conduct a full range of automated tests in a disease- specific panel on one instrument, including genetic diagnostics, immunoassays, cell counting and identification, and clinical chemistries.
Qiagen Inc. has launched the new BioRobot 9604 and QIAamp 96 Viral RNA kit as the standard solution package for high- throughput nucleic acid sample preparation for Specialty Laboratories' HIV-1 RNA UltraQuant viral load assays. The QIAGEN BioRobot 9604 targets nucleic acid sample preparation and handling tasks in clinical laboratories and blood banks. Nucleic acid samples purified on the BioRobot 9604 are ready for use in the demanding and sensitive downstream assays performed in molecular diagnostic, pharmaceutical and research applications.
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