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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 March 2000Inamco International Corp. is launching its diagnostic division under the banner of Advanced Diagnostics, Inc. The company intends to introduce kits designed for use in clinical chemistry, immunology, serology and as rapid (one-step) tests and ELISA kits. Rapid test kits include those for pregnancy, H. pylori, syphilis, cholera, drugs of abuse and cardiac markers. The ELISA test kits diagnose autoimmune disorders, fertility hormone, thyroid panel, infectious diseases and drug abuse. Avocet Medical, Inc., has received FDA clearance to market its new AvoSure PT-Pro prothrombin time test system, designed to be used by healthcare professionals. The system has also received waived status under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Avocet received prior FDA clearances for the AvoSure PT Pro+ for healthcare professional point-of-care use and the AvoSure PT for patient self-testing. PharmaNetics, Inc. and Bayer Diagnostics, are investigating the feasibility of developing a platelet function test to monitor the effect of platelet inhibitors. The test will use PharmaNetics' dry chemistry technology and the Bayer Diagnostics RapidPoint Coag platform. The platelet function test will be developed specifically to assess GPIIb/IIIa platelet inhibition in response to drugs like Eli Lilly and Co's Reopro (abciximab), and COR Therapeutics' Integrilin (eptifibatide). Beckman Coulter Inc. has received FDA clearance to market its Access Hybritech PSA and Access Hybritech free PSA blood tests performed on the Access Immunoassay system. Bionutrics, Inc., has obtained exclusive rights to a patented, diagnostic technology for measuring oxidative stress levels using a validated marker in urine or blood. This technology is based on the 8-epi-isoprostane, and is currently being integrated in a non-invasive test kit for in-home use. Oxidative stress has been associated with a wide spectrum of health problems, including heart attack, renal failure, neurological and inflammatory disorders, and accelerated aging. Bio-Rad Laboratories, Inc. has introduced the FDA approved TOX/See, a hand-held toxicology screening device that delivers drug testing results in 3 minutes. The device screens for commonly abused drugs including cannabis, cocaine, PCP, morphine, benzodiazepines, methodone and others. The test can also be customized for high-volume customers requiring testing of only a few specific drugs. Bio-Rad also markets the REMEDiT HS Drug Profiling System used in emergency rooms and forensics labs to simultaneously screen for more than 900 drugs and their metabolites with results in only 20 minutes. BioChem Pharma Inc. has completed the divestiture of its diagnostics division, BioChem ImmunoSystems Inc. ImmunoSystems' minority shareholder and a management group have assumed ownership of the diagnostics business and injected $5 million of new working capital. BioChem Pharma received a $54 million debenture to be paid out of future cash flows. Biopool International and Xtrana have signed a letter of intent to merge. Xtrana (formerly Molecular Innovations Inc.) has developed SCIP (self contained integrated particle) device, which combines the three essential steps of DNA analysis -- extraction, amplification and detection -- into a single device. The company has already introduced its first commercial product, Xtra Amp which performs the extraction step for DNA testing. In March Xtrana received a Small Business Innovation Research (SBIR) Phase I grant from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) to develop a nucleic acid-based detection system for Chlamydia trachomatis. Chronimed Inc.'s has announced its intent to spin-off its diagnostic products business. Management and operations of the new Diagnostic Products company will be independent of Chronimed Inc. CompuCyte Corporation and Olympus Optical Company, Ltd., have announced that they have entered into a distribution agreement for an initial term of three years, effective January 1, 2000. Olympus will sell CompuCyte's LSC Laser Scanning Cytometer product line in the Asia/Pacific market, including Japan, Hong Kong, Korea, Taiwan, Thailand, the Philippines, Singapore, Malaysia, Indonesia, China, India, Australia and New Zealand. DiagnoCure has received FDA clearance to market ImmunoCyt, a non-invasive diagnostic test to detect bladder cancer. DAKO Corporation will handle distribution of the test in the US. The company is also developing the uPM3 molecular test to detect prostate cancer. Digene Corporation has received FDA marketing clearance for its Hybrid Capture II Chlamydia/Gonorrhea Test for the simultaneous detection of Chlamydia trachomatis (CT) DNA and Neisseria gonorrhea (GC) DNA in cervical specimens. The test is indicated for use in women, with or without symptoms of infection, to identify or confirm the presence of Chlamydia and/or Gonorrhea. Abbott Laboratories distributes Digene's Hybrid Capture II Chlamydia and Gonorrhea Tests in Europe, Africa, and the Middle East, and will distribute the Digene CT-ID, GC-ID, and combination CT/GC Tests in the United States. Also this month the FDA approved Digene's High-Risk Hybrid Capture II HPV Test, a DNA-based technology designed to detect the 13 key types of HPV that cause cervical cancer in a single test. Prior to this approval, laboratories were required to test for both High-Risk and Low-Risk (or non-cancer causing) HPV types. This resulted in billing for two laboratory tests. Evolution Diagnostic Laboratory has introduced its At-home Semen Analysis Fertility Kit. The specimen is collected and sent overnight to the company's lab in a preservative solution. Results are directly mailed back to the patient in an unmarked envelope for privacy. EDL is an extension of Shore Institute for Reproductive Medicine located in Brick, NJ. Hemagen Diagnostics, Inc. has received FDA clearance to market its Total Protein, Albumin, Calcium, and GGT clinical chemistry reagents for use on the Roche Diagnostics Clinical Chemistry Analyzer, the Cobas Mira. Hemagen also manufactures and sells the Analyst Clinical Chemistry Analyzer. Hycor Biomedical Inc. has received FDA clearance to market its Rheumatoid Factor (RF) IgA ELISA autoimmune test. The Hycor RF IgA test completes Hycor's panel of tests for RA and complements the RF IgM and RF IgG tests previously cleared for marketing by FDA. LipoMed, Inc. and Bruker Instruments, Inc. have entered into a collaboration agreement to commercialize LipoMed's NMR LipoProfile test is used primarily by pharmaceutical companies and academic laboratories, around the world, in the development of new and more effective medications. The collaboration will use Bruker's (INCA), Integrated NMR Chemical Analyzer, as the testing platform. The NMR LipoProfile analysis quantifies the particle concentrations and size of 15 individual subclasses of HDL, LDL and VLDL. Meridian Diagnostics, Inc. has acquired a rapid blood test for active tuberculosis disease from the DiagnosTech subsidiary of La Jolla Diagnostics. The test utilizes a combination of three highly specialized Mycobacterium tuberculosis antigens that react with serum from persons having active TB, in just three minutes. This ability of the test to distinguish TB infection from active disease makes it ideal for helping medical professionals select the appropriate therapy. Cytometrics is developing a non invasive hand-held device that can perform a complete blood count (CBC). The device, created by Dr. James W. Winkelman, professor of pathology at Harvard Medical School and the director of Clinical Laboratories at Brigham and Women's Hospital in Boston, Massachusetts uses reflectance spectroscopy. The device is in the form of a small probe equivalent in size and weight to an electronic thermometer. Placed under the patient's tongue, it relays a picture to an image-processing unit of the individual's blood as it flows in the capillaries lining the mucous membranes underneath the tongue. Sybron International Corporation has acquired the assets of the Consolidated Technologies operations of SeraCare, Inc., manufacturer of quality control materials, intermediate biological products, in vitro diagnostic products and proficiency testing specimens. Their products include intermediate biological products, calibrators, and controls used in immunology, clinical chemistry, toxicology, infectious disease and nucleic acid testing. Trinity Biotech plc has acquired MarDx Diagnostics Inc. for a consideration of $4 million. MarDx is a manufacturer of test kits for the diagnosis of Lyme disease. Its principal product is a Western Blot test for Lyme disease.
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