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 2003
Beckman Coulter, Inc. and R&D Systems, a wholly owned subsidiary of Techne Corporation have signed a non-exclusive, multi-year agreement that calls for R&D Systems to develop automated cytokine assays and to manufacture assay components designed for Beckman Coulter's Access family of immunoassay systems. The new assays are expected to be commercially available beginning in 2004.
Cholestech Corporation has received FDA clearance to market its POC aspartate aminotransferase (AST) liver function test. The company plans to introduce an AST/ALT cassette in Europe in 2004 and plans to launch in the US when AST achieves waived status.
Corgenix Medical Corporation has received FDA clearance to market 11 enhanced products that detect antibodies to antiphospholipids. High levels of these antibodies have been reported in patients with antiphospholipid syndrome and characterized by recurrent thrombosis (blood clots), thrombocytopenia and fetal loss.
diaDexus, Inc. has signed an exclusive license agreement with Human Genome Sciences, Inc. giving HGS worldwide rights to develop and commercialize IHC tests based on the TRAIL Receptor-1 (TRAIL-R1) and TRAIL Receptor-2 (TRAIL-R2) proteins. diaDexus retains exclusive commercial rights for diagnostics based on TRAIL-R1 and TRAIL-R2 in other formats. The TRAIL (tumor necrosis factor apoptosis-inducing ligand) Receptor-1 and TRAIL Receptor-2 proteins were discovered by Human Genome Sciences. diaDexus acquired diagnostic rights to TRAIL-R1 and TRAIL-R2 through an agreement with GlaxoSmithKline.
The Genome Institute of Singapore is developing an electronic chip that can detect respiratory infections: flu, dengue fever, SARS or other respiratory diseases using Sputum or nasal fluid. The group intends to launch the chip in 2004.
Intel Corporation and the Fred Hutchinson Cancer Research Center are collaborating to apply Intel's expertise in nanotechnology to develop improved methods of studying, diagnosing and preventing cancer. Intel is building an Intel Raman Bioanalyzer System at the Fred Hutchinson Cancer Research Center. The instrument beams lasers onto tiny medical samples, such as blood serum, to create images that reveal the chemical structure of molecules. The goal is to determine if this technology, previously used to detect microscopic imperfections on silicon chips, can also detect subtle traces of disease.
Quest products, Inc. has introduced Ovulation Scope, an FDA approved home ovulation test using saliva. The device includes a built in mini-microscope in a lipstick tube sized apparatus. A woman puts her saliva on a slide and begins to see ferning lines instead of dots if she is in a fertile period of her menstrual cycle.
Tepnel Life Sciences PLC has agreed to acquire the diagnostics business of Orchid BioSciences, Inc. Orchid Diagnostics provides systems, consumables and services for HLA testing for organ transplantation matching, tests for cystic fibrosis genetic screening and certain related support services.
Product developments - September 2003
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Last modified: November 3, 2003