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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.

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Product developments in August 1996

Immucor Canada has begun marketing Biosite's Triage drug of abuse products and electrophoresis systems from Sebia.

Biopool International has received U.S. FDA approval to market the company's new Chromolize tPA Assay Kit, which measures the level of tissue plasminogen activator (tPA) in blood. The test kit also includes Biopool's unique patented Stabilyte Blood Collection Tubes, which are necessary for stabilizing tPA during blood collection for an accurate measurement of tPA levels.

Calypte Biomedical, Berkeley, Calif. has received notification from the FDA of the licensure of its diagnostic test for the detection of antibodies to HIV-1 in urine. The test, under the product names "Calypte HIV-1 Urine EIA" or Seradyn "Sentinel HIV-1 Urine EIA" will be available to physicians in public health clinics, hospitals and doctors' offices.

Dade International is developing a method and apparatus for assaying the sensitivity of biopsied tumor cells to chemotherapeutic agents using a predetermined amount of chemotherapeutic agent in an easily deliverable form.

Diametrics Medical, Inc. has introduced the IRMA(SL) Blood Analysis System, a second-generation of the company's IRMA point of care analyzer. IRMA(SL) has an expanded test menu that includes testing for blood gases, electrolytes and now features hematocrit testing. Also introduced is the IRMA Data Management System (IDMS) version 3.0. an advanced data management software program that provides a comprehensive data management system for point of care testing technologies. It features an open architecture design that allows the program to accept other applications and is network compatible.

Boehringer Mannheim has received FDA clearance for the Elecsys 2010 System. The new automated diagnostic systems employ the proprietary ORIGEN electrochemiluminescence technology developed by IGEN. Immunoassays offered with the initial test menu include those endocrinology and cardiac assessments, as well as for diagnosis of anemic and cancerous conditions.

Researchers at Boston University have discovered a noninvasive method to detect gastric Helicobacter pylori. The invention provides a method for measuring dissolved inorganic carbon (DIC) in body fluids: blood, serum, plasma, urine, sweat, saliva, lacrimal fluid, and combinations thereof.

Matria Healthcare, Marietta, GA has filed an application that would expand the use of the Fetal Fibronectin (fFN) immunoassay as a means for predicting risk of preterm delivery. The diagnostic test, manufactured by Adeza Biomedical Corporation and marketed by Matria in the U.S. and Canada, was approved by the FDA in 1995 to help physicians determine whether or not preterm delivery is likely among pregnant women who develop symptoms associated with preterm labor. The new Premarket Approval Application (PMA) seeks to expand the indication to help physicians identify risk for preterm delivery among asymptomatic patients who do not have preterm labor symptoms.

Matritech, Newton, MASS, has discovered three specific nuclear matrix proteins (NMPs) associated with cervical cancer. Matritech plans to generate monoclonal antibodies to identify these identified cervical cancer-target NMPs. These antibodies will be used with the new NMP-based cervical cancer systems from Bayer to detect cervical cancer-associated nuclear matrix proteins.

Palatin Technologies, Princeton, NJ, has received a $95,000 Small Business Innovation Research grant (SBIR) from the National Institutes of Health (NIH) for the development of a peptide-based nuclear medicine diagnostic tool to locate and image infection/inflammation sites within the body. The imaging technology currently being developed by the company is based on tuftsin, a tetrapeptide that is a natural component of the human immune system.

Roche Molecular Systems' new HIV-1 PCR Assay has been shown to be highly sensitive in the detection of vertical HIV transmission. The test kit, has a sensitivity and specificity of 95% and 97%, respectively, in the detection of HIV in infants between the ages of 1 and 36 months. The test has up to 100% sensitivity in the subgroup of infants aged 1 to 6 months who are HIV-infected.

Spectral Diagnostics announced that it has been advised by the U.S. Patent Office that a new patent will be issued in the United States which materially extends protection of Spectral's multiple analyte approach to cardiac diagnostics in determining the origins of chest pain. The patent will extend Spectral's multiple analyte approach to those drawn from an extensive list of combinations of cardiac analytes defined by their properties and independent of platform, including Troponin I, Troponin T, glycogen phosphorylase, fatty acid binding proteins, carbonic anhydrase etc. All methods of measuring these combinations will be covered by the new patent ranging from traditional laboratory analyzers to biosensors.

American Biogenetic Sciences, Copiague, NY has developed a patented Thrombus Precursor Protein (TpP) test intended to aid in assessing the risk of thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy by the quantitative determination of soluble fibrin polymers in human plasma. The detection of elevated levels of soluble fibrin polymer is indicative of pathological blood clot formation which may have clinical utility in the detection of various life threatening thrombotic conditions.

Trinity Biotech, Dublin, Ireland has launched two new rapid, one step tests for HIV and Hepatitis B - Uni-Gold HIV and Uni-Gold Hepatitis B. These tests require only one drop of either whole blood, serum or plasma and no other steps to determine the HIV or Hepatitis B status of a patient.

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