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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 September 2002
Abbott Laboratories Inc. has initiated a worldwide recall of 32 laboratory test kit lots used to diagnose gonorrhea, because some of those kits may give false negative results. Approximately 750,000 tests were involved. The kits were distributed to hospitals and laboratories from January 11 to June 24, 2002. Baxter Healthcare Corporation has received FDA clearance to market the ALYX Component Collection System, a portable, automated blood collection system that allows blood centers to collect two units of red blood cells, instead of just one, from eligible donors. It is expected to be available to US blood centers by the end of 2002. Bayer Diagnostics has received FDA clearance to market for the VERSANT HIV-1 RNA 3.0 Assay (bDNA), its nucleic acid probe diagnostic assay for the direct quantification of HIV-1 RNA in the plasma. Beckman Coulter, Inc. and PSS World Medical Inc.'s Physician Sales & Service (PSS) business have entered into an exclusive distribution agreement that establishes PSS as the exclusive distributor of Beckman Coulter's SYNCHRON CX chemistry product line to the US physician market and other alternate site providers. Bio-Tek Instruments has been awarded a patent for Determination of Platelet Reactivity in whole blood and monitoring of antiplatelet pharmacologic agents. The method facilitates a quantification of platelet activation reducing the chance of excess bleeding or clotting in these patients. The method offers promise for improved prediction of coronary artery and cerebrovascular disease in patients without a previous disease history. Calypte Biomedical Corporation announced that the West Virginia Office of the Insurance Commissioner has cleared its FDA-approved HIV-1 antibody tests that can be used on urine samples for use by the life insurance industry in all 50 states. Chemicon International, Inc. has launched the ATA100 Advanced Tissue Arrayer that provides a tool for building custom tissue microarrays using pre-existing paraffin blocks. Chemicon also released its West Nile OligoDetect kit, a post-amplification detection kit for the identification of genetic material specific to the West Nile virus. The kit comes in a high throughput 96 well format that is compatible with equipment common in most testing labs. DakoCytomation A/S has acquired the Artisan instrument business from CytoLogix Corporation. The Artisan is a tissue staining instrument used in pathology labs for cancer diagnosis. According to terms of the agreement, DakoCytomation will assume all rights to the product as well as responsibility for continued technical support and customer service. DakoCytomation US will retain the CytoLogix facility in Cambridge along with a number of CytoLogix employees. The site will be used for ongoing product development and for customer training and support on the East Coast. IMI International Medical Innovations Inc. has received a CE-mark for its skin cholesterol test, Cholesterol 1,2,3, allowing the product to be sold in Europe. Inverness Medical Innovations, Inc. and Ostex International, Inc. , a developer and marketer of technologies and products for the management of osteoporosis, announced today that they have signed a definitive merger agreement. Ischemia Technologies has received a Health Canada Therapeutic Products Directorate license to market for the detection of Ischemia Modified Albumin (IMA) by the Albumin Cobalt Binding (ACB) test. The test is currently available for sale in Europe, with US regulatory submission in process. IMA is used to diagnose acute coronary syndromes in conjunction with ECG and the cardiac marker, troponin. Matritech Inc. and Cytogen Corporation have reached an agreement in principle to enter into a five year agreement for Cytogen to be the sole US distributor for Matritech's FDA approved NMP22 BladderChek test, a point-of-care test for the management of patients with bladder cancer. MedPharm is distributing the FDA-cleared HealthTEST line of rapid tests for HIV, Hepatitis, STDs, malaria and other diseases. HealthTEST products use the patented Particle Immuno-Filtration Assay, PIFA technology. Pall Corporation has introduced a new Bacteria Detection System (Pall BDS) in Canada. The Pall BDS uses changes in oxygen concentration as a result of bacterial growth to detect bacterial contamination in platelets stored in plasma. A qualitative pass or fail reading is obtained. This results in the ability to detect and discard contaminated platelets while also eliminating the need for specialized training or capital equipment. Roche Diagnostics Corporation has received FDA clearance to market its Accu-Chek Compact Blood Glucose Monitoring System for alternative site testing, which means users can now draw blood samples from their fingertips, palms, forearms, upper arms, thighs or calves. Thermo BioStar, a Thermo Electron business has introduced the RSV OIA rapid immunoassay for the detection of respiratory syncytial virus (RSV), the most common cause of lower respiratory tract infections in children worldwide. Ventana Medical Systems Inc. has acquired Beckman Coulter Inc.'s HPV business and all corresponding assets for an undisclosed amount. The acquisition includes assignment of the HPV intellectual property portfolio acquired by Beckman from Institut Pasteur through a 1991 sub-license agreement. Institut Pasteur recently sold its remaining HPV rights to Roche Diagnostics.
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