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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 2001
Chiron Corporation has granted AcroMetrix a worldwide, semi-exclusive license for its hepatitis C (HCV) and HIV patent rights for use in nucleic acid diagnostics. AcroMetrix will manufacture and sell HCV and HIV nucleic acid probe quality controls, standards and quantification panels for in vitro diagnostics. Ampersand Medical Corporation has signed an agreement to acquire AccuMed International, Inc. The Companies expect to close the transaction during the second quarter of 2001. Ambion, Inc. has granted QIAGEN N.V. non-exclusive world-wide rights to use its RNAlater RNA stabilization technology in products and processes for the research market. RNAlater stabilizes RNA in tissues and cells for subsequent RNA isolation and for ambient shipping and more convenient and cost-effective storage of samples. bioMerieux S.A. has made an offer to purchase Organon Teknika's in vitro diagnostics business. Employee representative bodies and unions have been informed about the offer and the required regulatory approvals will be sought. Biopool International Inc./Xtrana has received FDA clearance to market its new MiniQuant D-dimer Assay System, a rapid, quantitative method for determining D-dimer containing fragments in plasma. Elevated levels of D-dimer are found in such clinical conditions as deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. The MiniQuant D-dimer Assay System includes Biopool's latex agglutination reagent and the MiniQuant-1, a hand-held detection instrument. Calypte Biomedical Corporation and Organon Teknika Corporation, have signed an agreement whereby OT will distribute worldwide an HIV-1 Western Blot serum assay manufactured by Calypte Biomedical. ChoicePoint Health Systems, a subsidiary of ChoicePoint Inc. has launched the direct-to-consumer FDA-cleared Appraise Hemoglobin A1c test. Corgenix Medical Corporation is developing new test kits to be used in the diagnosis and risk assessment of certain cardiovascular disorders characterized by blood clot formation. The new tests, IgG anti-Prothrombin and IgM anti-Prothrombin (aPT) antibody test kits will become a part of Corgenix ELISA based diagnostic assays for antiphospholipid antibodies. Cyrano Sciences is developing an "electronic nose" that may be able to detect tuberculosis and other infectious diseases from a breath sample. The system, similar in size to a laptop computer, combines chemical sensor arrays and artificial intelligence to detect the difference between TB-positive and TB-negative samples. Diabetex International Corporation is developing a non-invasive blood glucose meter combined with an insulin infusion pump. DiaSys Corporation has developed a urine-based rapid test for multiple myeloma. The test is available in Europe for research purposes and the Company is implementing plans to expand the technology to include other types of cancer, and to bring the technology to the United States, China and other world markets. Digene Corporation has received expanded funding for its Phase II Small Business Innovation Research (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a new test for herpes simplex virus (HSV). Digene will apply its Hybrid Capture technology for the detection, screening and monitoring of patients with HSV types 1 and 2 infection. Dynacare Inc. and Luminex Corp. have formed a partnership, DYNAGENE, to develop and commercialize a range of clinical laboratory assays based on Luminex's LabMAP technology. The collaboration aims to produce genetic screening tests for inherited diseases. Infectech, Inc. has introduced the Identikit, a paraffin slide culture technique for the cultivation of nontuberculous mycobacteria. It has been used for isolating M. avium-intracellulare from blood cultures. The growth on the slides can even be used for DNA extraction for molecular studies. Enterix Inc. has received FDA clearance to market its colorectal cancer screening test, !nSure, an immunochemical fecal occult blood test. Available in Australia since June 2000, the screening test already is being used by more than 900 primary care physicians to test for colorectal cancer. Inverness Medical Technology, Inc. has signed a definitive agreement to acquire LXN Corporation, a privately-held firm active in the development and commercialization of fructosamine monitoring technology for people with diabetes. The transaction will be accomplished as a merger in which LXN will become a wholly owned subsidiary of Inverness Medical Technology. LifeScan has introduced the ONE TOUCH Ultra Blood Glucose Monitoring System, a new system that uses 1 microliter of blood taken from the arm, where there are fewer nerve endings than in the fingertips. MetaMetrix Clinical Laboratory has developed QuikStiX, a fingerstick food allergy test, QuikStiX. The test kit includes illustrated instructions, two disposable lancets, a sample collection card, and return mail packaging. The test measures the IgG immune response to the ten of the most common foods (egg, wheat, milk, corn, soy, rice, mustard, salmon, tuna, and beef) and two types of mold (penicillium and aspergillus) commonly found in many processed foods. Media-Pharma and Kimberly-Clark are developing Smarty Pant, panty liners impregnated with gum guaiac wood resin, which turns blue in the presence of tiny traces of blood, and a pH sensor such as carminic acid, which turns red between pH 4 and 7. These markers turn purple four hours ahead of menstruation, giving the wearer plenty of notice. Another panty liner that pinpoints ovulation has a plastic film coated with amorphous silicon that changes thickness slightly in response to changes in the levels of estrogen, progesterone and follicle-stimulating hormones. The product can also test for pregnancy and detect substances which signal bacterial, fungal and viral infection, including Escherichia coli, Salmonella, Candida, Chlamydia and HIV. Quidel Corporation has launched the Metra Helical Peptide immunoassay, a urine test for measuring the breakdown of collagen, a biochemical bone marker for osteoporosis and related diseases. Roche Molecular Systems unit has received a patent for its methods of monitoring nucleic acid amplification reactions such as the polymerase chain reaction. The patent reinforces Roche's patent coverage in the area of real-time amplification, detection and quantitation. Sybron International Corporation has changed its name to Apogent Technologies Inc. effective January 31, 2001. The company reported the primary reasons for the name change are to better reflect the company's business in its name and to distinguish the company from and avoid confusion with Sybron Dental Specialties, Inc., which the Company spun off to its shareholders on December 11, 2000. ZymeTx, Inc. and Polaroid Corporation have launched clinical trials to evaluate an infectious disease diagnostic platform with initial application in influenza detection. The platform features a chemiluminescence film detection system that chemically captures small emissions of light on high-speed instant film when there is the presence of an infectious organism.
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