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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 October 2002
Alfigen, Inc. has introduced the Quadruple Marker Prenatal Screening Test to physicians and other laboratories. The Screening Test is a blood screening test done in the second trimester of pregnancy to help detect an increased risk for Down Syndrome, trisomy 18, and neural tube defects or abdominal wall defects. The test measures AFP (alpha-fetoprotein), hCG (human chorionic gonadotropin), uE3 (unconjugated estriol), and dimeric Inhibin A. These test values, together with maternal age, are then entered into a mathematical formula to determine the risk for the various abnormalities. Biomerica, Inc. has launched its FDA cleared calcitonin test in the US and Europe. The test is used to diagnose cancer of the thyroid and as an adjunct for the monitoring of osteoporosis of a patient. Calcitonin is a hormone produced in the thyroid gland that helps regulate blood calcium. Biomerica, Inc. has also been contracted to develop a food allergy test for the Kyowa Medex Company. The test is a semi-quantitative ELISA format test kit able to detect specific IgG in human serum to 14 food allergens, and will be made using foods specifically endemic to Japan. ChromaVision Medical Systems, Inc. has received FDA clearance to market its ACIS system to quantify the presence of estrogen receptors and progesterone receptors (ER/PR) at the cellular level. The tests are used to help physicians determine an appropriate course of treatment for breast cancer patients. Dade Behring has introduced the new N Latex Lipoprotein(a) assay, an automated test for the detection and measurement of Lipoprotein(a) on its BN instruments. Diagnostic Products Corporation has received FDA clearance to market the IMMULITE 1000 Automated Immunoassay System, the latest addition to the IMMULITE family of systems. The IMMULITE 1000 adds on-board dilutions, Windows 2000 operating software and a consolidated footprint. The IMMULITE systems offer tests for 100 immunoassays and 240 different allergens. Gen-Probe Incorporated has received $1.0 million from the National Heart, Lung and Blood Institute of the National Institutes of Health to begin development of a nucleic acid screening test for the detection of West Nile virus. The funds have been added to Gen-Probe's current contract, which was established in 1999 for the development of NAT assays for HIV-1, HCV and HBV. IDEXX Laboratories, Inc. has launched its LaserCyte Hematology Analyzer, an in-clinic veterinary diagnostic instrument. The LaserCyte system uses proprietary laser-flow cytometry and provides comprehensive hematological diagnostic information at the point of care. ILEX Oncology, Inc. has acquired global exclusive commercial rights to CAMPATH (alemtuzumab)-related diagnostics, including CD52 antigen testing, from BTG International Limited. CAMPATH works by targeting the CD52 antigen, resulting in the removal of malignant lymphocytes from the blood, lymph nodes, bone marrow, and other affected organs. ILEX is now finalizing sublicensing plans with diagnostics partners to establish CD52 antigen testing as standard practice in the diagnosis of leukemias and lymphomas. Immunicon Corporation has received FDA clearance to market its CellPrep Sample Preparation System, a general-purpose laboratory instrument used with immuno-magnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells from whole blood. Cell analyzers such as the CellTracks analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. Isotechnika Inc. and its wholly owned diagnostics division, Isodiagnostika have received from the United States Patent and Trademark Office, two patents relating to its diagnostic test, Diatest, a C13 glucose breath test for the diagnosis of diabetic conditions and monitoring glycemic control and insulin resistance. LabCorp and Celera Diagnostics have formed an agreement to collaborate in establishing the clinical utility of laboratory tests based on novel diagnostic markers for Alzheimer's disease, breast cancer and prostate cancer. LipoScience, Inc. has received a Notice of Allowance in connection with its patent application for a diagnostic test to identify Insulin Resistance based on the company's proprietary nuclear magnetic resonance (NMR) technology. Matritech Inc. has reached an agreement in principle for its NMP66 breast cancer test with Mitsubishi Kagaku Medical Inc. Matritech will complete the development of the blood test method using Mitsubishi's input and conduct an initial validation study using specimens from women in Japan provided by Mitsubishi. Mitsubishi will perform a clinical trial in Japan and offer the test for routine use by its clinical laboratory. Pall Corporation has received FDA clearance to market the Pall RC2D Leukocyte Reduction Filter that processes blood faster and with greater improved plasma recovery. Phase 2 Discovery has licensed its proprietary biomarker, C-tau, to Biosite Incorporated which intends to evaluate C-tau for use in diagnostic tests for stroke and brain injury. The agreement grants Biosite a license for the detection of C-tau in biologic fluids except for cerebrospinal fluid. Polymer Technology Systems has received a CLIA waiver for its PTS PANELS Lipid Panel Test Strip, run on the company's PTS CardioChek PoA test system. The strips provide lipid results total cholesterol, HDL cholesterol, triglycerides, and calculated LDL cholesterol from a single drop of blood. Prometheus Laboratories Inc. has introduced FIBROSpect, a non-invasive approach to help detect liver fibrosis in patients with chronic hepatitis C. The test measures three biological markers associated with the development of liver fibrosis. Quest Diagnostics Incorporated and Celera Diagnostics are collaborating in establishing the clinical utility of laboratory tests based on novel diagnostic markers for cardiovascular disease and diabetes. This collaboration will support current and future disease association studies at Celera Diagnostics that seek to identify genetic markers associated with these important diseases. The agreement provides Quest Diagnostics with exclusive access to the markers and establishes Celera Diagnostics as a preferred vendor to Quest Diagnostics for certain molecular diagnostic products. Seradyn Inc. has acquired Opus Diagnostics Inc., from Caprius, Inc. Opus transferred certain assets, rights, and properties including the Innofluor TDM product line, to Seradyn, Inc. Seradyn has been the contract manufacturer for the Innofluor TDM reagents since January 2001. Seradyn will also assume the ongoing Opus Research and Development projects. Xtrana, Inc. has been awarded $986,051 over the next three years from the National Institutes of Health to develop a nucleic acid-based, POC microfluidic device to detect a panel of respiratory viruses from a single patient sample. Xtrana will collaborate with Micronics, Inc. for lab card and integrated device development, and The Children's Hospital in Denver for clinical specimens and medical expertise.
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