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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 December 2001
ABAXIS has introduced the MetLyte 8 and Basic Metabolic Panel for its Piccolo blood chemistry analyzer for the medical market. The MetLyte 8 panel includes tests for chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and urea nitrogen. The Basic Metabolic panel includes tests for calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide and urea nitrogen. ABAXIS now offers a total of seven different blood chemistry panels for the Piccolo chemistry analyzer. American Bio Medica Corporation has received FDA clearance to market its on-site drug test capable of identifying use of the illegal designer drug MDMA (Ecstasy). Rapid One Ecstasy is a one-step immunoassay capable of detecting MDMA use at concentration levels of 1000 ng/mL in urine. DAKO A/S has secured the exclusive rights to market Aperio Technologies Inc.'s ultra-fast digital ScanScope slide scanner for the analytical imaging of DAKO's slide-based assay systems. The ScanScope is a high-resolution microscope slide scanner that digitizes an entire slide at diagnostic resolution in minutes and converts all information available on a microscope slide into a standard digital format. Bayer Diagnostics has announced that the American Medical Association has approved a unique Current Procedural Terminology (CPT) code for the serum HER-2/neu oncoprotein test. The CPT code, 83950 becomes effective January 1, 2002, for most health insurance programs. Additionally, the Center for Medicaid and Medicare Services (CMS) has proposed that the oncoprotein HER-2/neu serum test be reimbursed at $89.01. BTG has acquired a new diagnostic technology that has the potential to offer real-time detection of infectious diseases -- such as anthrax, smallpox, AIDS and influenza. The primary application for the fiber optic-based sensor is in the point-of-care medical market. The technology has been tested for Rubella; Bacillus globigii; MS2 virus; Erwinia herbicola and ovalbumin. Caliper Technologies Corp. and Bacterial BarCodes, Inc., have formed an agreement to co-distribute clinical diagnostic systems based on Caliper's LabChip microfluidic technology and Bacterial BarCodes' proprietary rep-PCR bacterial fingerprinting technology. The new system will be designed for the detection and diagnosis of invasive bacterial infections. The CDC has developed and validated test kits for several bio-threat agents optimized for use on Cepheid's Smart Cycler DNA detection systems. The CDC is providing the test reagents to the Laboratory Response Network - over 80 state and local public health and military laboratories. Cepheid has granted Environmental Technologies Group Inc. a worldwide, non-exclusive sublicense to key patents for development of rapid, handheld DNA analysis systems for bioagent detection. Cepheid will receive royalties on ETG system sales and retains rights to commercialize the handheld systems for all other DNA-testing applications, including environmental testing and veterinary diagnostics. Cepheid holds the exclusive license to these patents from the Regents of the University of California and Lawrence Livermore National Laboratories (LLNL). ETG is preparing to commercialize the Handheld Advanced Nucleic Acid Analyzer, originally developed by LLNL. Dade Behring has received FDA clearance to market a whole blood quantitative hemoglobin A1C for use on its Dimension Integrated Chemistry Systems including the RxL, XL, ARx and Xpand models. diaDexus, Inc. has licensed its proprietary genomics-based diagnostic test for the non-invasive detection of colorectal cancer to Quest Diagnostics Inc. The test detects Reg-4, a protein that has been implicated as a critical component of colorectal carcinogenesis. International Diagnostic Technologies, Inc. (IDT) is seeking partners to develop its Photonic Molecular Probe and Solid State Molecular Sensor for chemical and biological agent detection. The Photonic Molecular Probe is designed to identify and quantify target analytes based on the transmission/reflection dichroic spectra of targeted molecules. Inverness Medical Innovations, Inc. has acquired has acquired from Unilever U.K. Holdings Limited the four subsidiary companies that comprised the Unipath business: Unipath Limited, Unipath Diagnostics GmbH, Unipath Scandinavia A. B. and Unipath B. V. Included in the assets acquired are facilities in Bedford, England, U.S. marketing and sales operations in Princeton, New Jersey. Inverness paid 103 million pounds sterling (approximately $150 million) in cash. LabCorp has introduced the PreGen-26, a DNA-based colorectal cancer test developed by EXACT Sciences Corporation. PreGen-26 targets Hereditary Non-Polyposis Colorectal Cancer (HNPCC) -- an inherited predisposition to develop colorectal cancer. PreGen-26 is intended to detect the presence of actual disease. The test is expected to become a part of HNPCC patients' routine surveillance examinations. LabCorp has also become Myriad Genetics' exclusive sales and distribution partner, for all of Myriad's predictive medicine products including the company's three cancer and one hypertension predictive products. Ortho-Clinical Diagnostics, Inc. and Caprion Pharmaceuticals Inc. have entered into an exclusive licensing agreement to develop a human blood test for variant Creutzfeldt-Jacob Disease (vCJD), the human equivalent of Mad Cow Disease. OCD has obtained worldwide exclusive rights in marketing and distribution for human in vitro diagnostic applications and will fund all development activities and regulatory expenses. Quantech Ltd. has formed a 100% Quantech owned corporation called FasTraQ, Inc. to commercialize the FasTraQ-ER Patient Treatment Information System. Specialty Laboratories, Inc. and VIRalliance, a subsidiary of BioAlliance have begun the U.S. introduction of Phenoscript, a new proprietary phenotyping test to predict resistance to antiviral drugs used in HIV therapy. The test has been developed by VIRalliance, in collaboration with the Pasteur Institute and the Institut National de la Sante et de la Recherche Medicale (INSERM). Zeus Scientific, Inc. and Luminex Corporation have received FDA clearance to market Zeus's AtheNA Multi-Lyte ANA Test System with Active Calibration Technology. The system is based on Luminex's LabMAP technology. Zeus currently markets a successful line of IFA (Immuno-fluorescent Assays) and ELISA (Enzyme-Linked Immuno Sorbent-Assays) based tests in the autoimmune testing market. Zeus intends to begin marketing the system in the first quarter of 2002 through a distribution partnership with Wampole Laboratories.
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