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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 Summer 2004
Summer is over and its back to work. It has been a very busy summer, news-wise. We have chosen to present some of the more innovative news items. We are back to our monthly update schedule, so feel free to visit regularly. ABAXIS, Inc. was granted CLIA waived status for their lipids test panel when used in conjunction with their Piccolo point of care analyzer. AdvanDx, Inc. entered into a multi-year agreement with Cedars-Sinai Medical Center whereby Cedars-Sinai will incorporate AdvanDx's rapid PNA FISH tests for the identification of S. aureus, C. albicans and E. faecalis directly from positive blood culture bottles. Akers Biosciences Inc. received FDA clearance to market its rapid test for Heparin/Platelet Factor-4 (HPF-4) antibodies. The HealthTEST HPF4 antibody test is designed to identify patients at risk for developing heparin-induced thrombocytopenia and thrombosis syndrome, an allergic-like side effect associated with the use of the anticoagulant heparin. American Bio Medica Corporation began manufacturing its own oral-fluid based point of collection device that will be sold under the trade name of OralStat. ABMC had previously private-labeled a third-party's oral fluid device. Bayer Diagnostics introduced the ADVIA Urinalysis WorkCell system, a fully automated and integrated system for urine chemistry and urine cell analysis. The ADVIA Urinalysis WorkCell integrates Bayer's Clinitek ATLAS Urine Chemistry Analyzer with Sysmex's UF-100 Urine Cell Analyzer. Beckman Coulter, Inc. acquired exclusive global sales and marketing responsibilities for PointCare Technologies, Inc.'s PointCARE system for POC monitoring drug therapy in HIV/AIDS patients. The PointCARE monitoring system enables CD4 monitoring for use in remote locations. bioMérieux received FDA clearance to market the VIDAS D-Dimer Exclusion assay for exclusion of pulmonary embolism (PE) as a diagnosis, adding it to the already recently-cleared deep vein thrombosis (DVT) intended use. VIDAS D-Dimer Exclusion is the only assay with this FDA clearance. Biosite Incorporated received FDA clearance to market the Triage Profiler Shortness of Breath Panel that includes: B-type natriuretic peptide (BNP), D-dimer, myoglobin, CK-MB, and cardiac troponin I. Calypte Biomedical Corporation signed a sublicense agreement with Abbott Laboratories, Inc. for worldwide rights to use a family of patents known as the Guire/Swanson patents. The technology underlying these patents is fundamental to all lateral-flow rapid diagnostic tests. Chiron Corp. acquired Prion Solutions Inc. as part of a strategy to develop a test that could be used to screen blood donations for mad cow disease prions. Dade Behring received FDA clearance to sell its NT-proBNP assay on the company's Dimension instruments. Dade Behring and Diagnostics Products Company entered an agreement in which Dade Behring will offer its StreamLAB workcell customers the ability to integrate DPC's IMMULITE 2000 and IMMULITE 2500 systems within the StreamLAB workcell. DiaSys Corporation launched ten new point of care rapid test products for worldwide distribution. The tests include four cardiac markers - Troponin I, CK-MB, Myoglobin, and CRP; three cancer markers - Id1, HMGA2 and Alpha Fetoprotein; two infectious disease tests - Malaria Combo Test and Dengue IgG and IgM; and a Neonatal TSH. Diagnostic Products Corporation will distribute Thermo Electron Corporation's Thermo Konelab clinical chemistry systems and the TCAutomation laboratory automation products in Spain, Portugal, Belgium, The Netherlands and Luxembourg. In France and Germany, DPC will market the Konelab product line together with the IMMULITE family of systems, while both companies will continue to serve their other customers. Genzyme Corporation introduced OSOM BVBLUE, a rapid test for the diagnosis of bacterial vaginosis. The test complements the OSOM Trichomonas Rapid Test launched spring 2004. Both tests detect pathogenic antigens directly from vaginal swabs with results available within approximately 10 minutes. Immunetics, Inc. has received FDA clearance to market its test for anthrax infection test for use on patient blood specimens. Inverness Medical Innovations, Inc. acquired Advantage Diagnostics Corporation a company that specializes in rapid test development and component manufacturing. The company holds one of the key families of lateral flow patents central to the rapid diagnostic industry. Inverness also acquired an exclusive, worldwide license in the field of women's health to certain patents owned by Metrika, Inc. The acquisitions will be used in the development of a series of digital women's health products, the first of which is slated for introduction in 2005. LabNow Inc. has been established to commercialize a portable flow cytometer device that measures CD4 cells within 15 minutes and works on rechargeable batteries. The device was developed at the University of Texas to serve as a mobile HIV testing laboratory in emerging countries. The instrument will be priced at less than $1,000, with each test costing under $5. Matritech, Inc. and Wampole Laboratories, LLC, a wholly owned subsidiary of Inverness Medical Innovations, Inc. signed an agreement giving Wampole exclusive rights to distribute the NMP22 ELISA Test Kit to hospitals and clinical reference laboratories in the United States. Matritech's own sales force will continue to sell the NMP22 BladderChek Test directly to urologists in their offices. MedMira Inc. received FDA clearance to market Reveal G2 Rapid HIV-1 Antibody Test (Reveal G2) for HIV-1 antibodies in human serum or plasma. The test features, an on-board control line. Meretek Diagnostics Inc., an Otsuka subsidiary, received FDA clearance to market the POCone Infrared Spectrophotometer a13C urea breath test for H. pylori. Meridian Bioscience, Inc. received FDA clearance to market ImmunoCard Toxins A&B, a rapid test for C. difficile, a major cause of antibiotic-associated colitis. OraSure Technologies, Inc. received a worldwide, non-exclusive sublicense from Bio-Rad Laboratories under patents relating to HIV-2. Bio-Rad is the exclusive licensee of Institut Pasteur, Paris, France, under the HIV-2 patents. Signet Laboratories, Inc. launched NEPHROSCREEN, a predictive diagnostic for detecting early signs of acute renal failure. The assay is based on the detection of adenosine deaminase binding protein (ADBP) in urine, which is released from kidney brush border epithelial cells into the urine during acute renal failure. Signet also released its DJ-1 monoclonal antibody, which is a potential diagnostic for predicting the emergence of Parkinson's Disease. The DJ-1 protein has been recently identified as causative of early-onset, autosomal recessive Parkinson's Disease. Smiths Medical MD, Inc. received FDA clearance to market the CoZmonitor blood glucose module. The CoZmonitor blood glucose module is attached to the back of the Deltec Cozmo insulin pump to create a combined insulin pump and blood glucose monitoring system. Trinity Biotech plc received a CLIA waiver for the Uni-Gold Recombigen HIV test. The test was approved by the FDA in December 2003. UriDynamics, Inc. introduced HydraTrend, an OTC urine test strip kit for monitoring an individual's hydration status over time. The test strips measure specific gravity and pH of the urine. Results will indicate whether hydration status is very good, good, fair or poor. Ventana Medical Systems Inc. received FDA clearance to market the VentanaDx c-KIT rabbit monoclonal antibody kit to detect the presence of the c-KIT protein in gastrointestinal stromal tumors (GISTs). c-KIT can be used in the selection of patients who may be eligible for treatment with Novartis' Gleevec (imatinib mesylate). Veridex LLC, a Johnson & Johnson company, is developing the CellSearch system to automate the detection and enumeration of circulating tumor cells directly from whole blood and the GeneSearch system to diagnose, stage tumors during lumpectomy surgery.
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