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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 January 2003
ABAXIS, Inc. has received FDA clearance to market tests for total cholesterol, high density lipoprotein and triglycerides. The company also received certification from the Cholesterol Reference Method Laboratory Network of the Centers for Disease Control for its Total Cholesterol and HDL assays. The Piccolo Lipid Panel measures Total Cholesterol, HDL and Triglycerides, and reports calculated values for Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL) and the ratio of Total Cholesterol to HDL. Abbott Laboratories and Luminex Corporation have signed agreements that grant Abbott license, supply and distribution rights to Luminex's xMAP technology, for the development of assays and proprietary instruments. The companies also signed a supply and distribution agreement granting Abbott rights to purchase and distribute Luminex products. AcroMetrix Corporation signed an exclusive agreement with Nabi Biopharmaceuticals to offer ViroSure quality control products for infectious disease testing to clinical laboratories and blood screening organizations. Agilent Technologies Inc. and MIDI, Inc. received FDA clearance to market the MIDI Sherlock Mycobacteria Identification System, used to identify Mycobacterium tuberculosis (TB). The Sherlock system uses the Agilent 1100 Series High Performance Liquid Chromatograph (HPLC) to analyze mycolic acids derived from cultured bacterial samples. Sherlock analyzes the mycolic acids in the bacterial sample, then searches its library of reference mycobacteria using pattern recognition software. Genaissance Pharmaceuticals, Inc. has entered into a collaboration with Bayer Diagnostics to identify pharmacogenomic markers of drug safety and efficacy. Genaissance will receive funding to apply its HAP Technology to Bayer's clinical samples. Bayer will receive exclusive rights to develop and market diagnostic tests based on the results of the collaboration. Genaissance will receive royalties and rights to perform these diagnostic tests in Genaissance's diagnostic laboratory. BD (Becton, Dickinson and Company) introduced two new FDA-cleared blood glucose monitoring products, the BD Logic Blood Glucose Monitor and the BD Latitude Diabetes Management System. These devices combine the thinnest lancets available with test strips that require a very small amount of blood and deliver accurate readings in five seconds. As part of the new product launches, BD has entered into strategic relationships with Medtronic MiniMed, the diabetes management business of Medtronic, Inc., and Eli Lilly and Company to increase its diabetes care market presence. Digital Angel Corp. is collaborating with the University of California School of Engineering at Riverside to accelerate the integration of medical and environmental biosensor technologies into its expanding line of wireless communications devices. Diagnostic Products Corporation has received a license from Compugen Ltd. to develop and commercialize diagnostic assays based on two novel prostate-specific proteins for the screening, detection and monitoring of prostate and other cancers. Compugen has discovered a PSA-linked molecule (PSA-LM) and an hK2-linked molecule (K-LM) that are encoded by alternative mRNA splice variants of the genes for prostate-specific antigen (PSA) and a related protein, human kallikrein 2 (hK2). Hycor Biomedical Inc. has received FDA clearance to market its Anti-Beta-2-Glycoprotein (-2-GPI) IgG and IgM autoimmune tests. (beta)-2-GPI is used in the diagnosis of antiphospholipid syndrome which can occur as a complication of various autoimmune diseases. Recent studies suggest that antibodies to (beta)-2-GPI are the causative agents in the development of APS. Infratec is developing a technique that measures blood glucose by checking heat emissions from the tympanic membrane of the ear, or eardrum. A hand-held device, much like an ear thermometer, measures thermal emissions in the mid-infrared range, which vary based on glucose concentration in the tissue. Meridian Bioscience has received FDA clearance to market an additional claim related to its ImmunoCard STAT! E. coli 0157 Plus. This new claim will enable the toxin-producing E. coli 0157 antigens to be detected from the most commonly used collection and transport culture medium. Metrika Inc. has received FDA clearance to make its A1cNow diabetes monitor available to patients over-the-counter, without a prescription. The first in Metrika's Now line of diabetes monitoring devices, the disposable, pager-sized A1cNow Monitor provides quantitative A1C results in just eight minutes from a small drop of blood. A1cNow is available through mail order and pharmacies for a retail price of $22-$25. Nymox Pharmaceutical Corporation has launched a new kit for its AlzheimAlert test that is designed for export outside the US. The kit will retail for $140 per individual test. AlzheimAlert is Nymox's proprietary urine test designed to aid physicians in the diagnosis of Alzheimer's disease. OraSure Technologies, Inc. has received CLIA waiver for its OraQuick Rapid HIV-1 Antibody Test. With this waiver, the OraQuick test, which provides HIV-1 test results in just 20 minutes, can be used by a larger number of sites in the United States, including outreach clinics, community-based organizations and physicians' offices. Pall Corporation has received FDA clearance to market a pre-donation, blood Sample Diversion Pouch on its Leukotrap blood collection and filtration systems. The pouch is used to divert the initial volume of blood during collection, which can contain the highest levels of bacteria. Transmission of bacterial contaminated blood products is the number one infectious risk of a blood transfusion. The Pasteur Institutes of Madagascar and Paris have developed a rapid dipstick test for the diagnosis of bubonic and pnuemonic plague. Based on the same principle, the researchers also have also developed strips for the rapid diagnosis of cholera. Roche Diagnostics and Affymetrix, Inc. have formed an agreement granting Roche access to Affymetrix's GeneChip brand technologies to develop and commercialize diagnostic products in a broad range of human disease areas such as cancer, osteoporosis, cardiovascular, metabolic, infectious diseases and inflammatory diseases. The agreement gives Roche non-exclusive rights to Affymetrix’ array and instrument technologies for up to 18 years. It will enable Roche to create and market GeneChip laboratory tests for DNA analysis, genotyping, and resequencing applications, as well as for RNA expression analysis. Healthcare Technologies and its subsidiary, Savyon Diagnostics Ltd. have entered into an agreement with Dr. Martin Lee, founder and former chief executive officer of Great Smokies Diagnostic Laboratory, to organize a new Israeli company to acquire Savyon's clinical laboratory diagnostics business for a purchase price of approximately $1.9 million. Savyon will continue to own and operate its clinical laboratory genetic diagnostics business. Healthcare and Dr. Lee will each own 50% of the newly organized company, and Dr. Lee will be the chief executive officer of this company. SomaLogic and Merial Limited are developing blood and tissue-based aptamer-based diagnostics for bovine spongiform encephalopathy - mad cow disease. SpectraCell Laboratories has introduced 6 new nutritional tests for - Vitamin D, Vitamin E, Selenium, Coenzyme-Q10, Lipoic Acid, and Carnitine. SpectraCell's FIA tests measure functional levels of a broad range of vitamins, minerals, amino acids and antioxidants, as well as other essential nutrients. SpectRx, Inc. and Abbott Laboratories have terminated their research, development and license agreement to jointly develop a continuous glucose monitor. SpectRx took this action because the company felt the development program for the device has not proceeded fast enough. SpectRx has also asked the U.S. patent office to resolve an inventorship dispute involving issued Abbott patents related to Abbott's glucose monitoring technology. SpectRx has re-initiated development work on its continuous glucose monitoring technology and all of SpectRx's rights to the continuous glucose monitoring technology were returned. Tessera Diagnostics, Inc. has licensed 14 prostate-specific cancer markers from The Johns Hopkins University and additional 17 prostate-specific cancer markers from the University of Pittsburgh. In addition, strategic alliances for the application of these markers in imaging, therapeutics, and drug discovery are being pursued. TREK Diagnostic Systems and Savyon Diagnostics, Ltd. have signed an agreement giving TREK exclusive US distribution rights for the onSite urine culture device and gives TREK the option for future manufacturing license of this product. The onSite device is a transparent, hinged plastic casing containing face-to-face plates of agar with a plastic sampler having two bent tips located between the plates.
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