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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 November 2002
Aphios Corporation was granted U.S. Patent No. 6,465,168 for Aphios' virus inactivation process capable of inactivating enveloped and nonenveloped viruses. The process utilizes supercritical, critical, or near-critical fluids with/without cosolvents (SuperFluids). The process is purely physical and does not utilize organic solvents, heat, irradiation, and/or chemicals commonly used in commercially available virus inactivation techniques. Bayer Diagnostics has received FDA clearance to market its GuideLines 6.0 Rules, the next-generation interpretative software used with the TRUGENE HIV-1 Genotyping Test. Beckman Coulter, Inc. has introduced its Class II major histo-compatibility complex (MHC) Tetramer reagents that detect and quantitate CD4+ antigen-specific T cells involved in diseases such as type I diabetes, rheumatoid arthritis and multiple sclerosis in particular Class II restricted T cells. CHEMICON International, Inc. has introduced its Hypoxyprobe line of products designed to detect oxygen gradients under normal and pathological conditions. Under its agreement with NPI, Inc., CHEMICON owns the exclusive worldwide rights (research use only) for the Hypoxyprobe detection system. Hypoxyprobe kits consist of a small molecule hypoxia marker, pimonidazole hydrochloride, that selectively binds to oxygen starved cells, and a monoclonal antibody, Hypoxyprobe-1-Mab1, that is used to detect pimonidazole adducts using standard laboratory methods. The kits can be used in multiple biological tests, including cell culture and in vivo hypoxia studies, fine needle aspiration, peroxidase and immunofluorescence microscopy, ELISA, and flow cytometry. Corgenix Medical Corporation has obtained an exclusive worldwide license (except in Japan) from Eiji Matsuura, PhD of Okayama University Graduate School of Medicine and Dentistry, Okayama, Japan, to use the patented technology, which is based on the unique interaction of oxidized LDL with B2GPI and the novel method to determine human oxidized lipoproteins. Correlogic Systems, Inc. has signed co-exclusive licensing agreements with Quest Diagnostics Incorporated and LabCorp for the commercialization of Correlogic's ovarian cancer protein pattern blood test. Correlogic will receive signing, milestone and per test royalty or service fees, as well as development fees for additional refinements to the technology. Additional terms were not disclosed. Gen-Probe Incorporated has received FDA clearance to market its Qualitative HCV Assay based on its proprietary Transcription-Mediated Amplification (TMA) technology. The test is a nucleic acid probe diagnostic assay for the qualitative detection of HCV RNA in patients infected with hepatitis C. The assay will be marketed to clinical laboratories in the US by Bayer Diagnostics under the brand name, VERSANT. HemoSense, Inc. has received FDA clearance to market its INRatio Self-Test PT Monitoring System for use by patients in the home. INRatio is a portable, handheld analyzer that performs the Prothrombin Time (PT) test. The device has also been granted the European CE Mark for use by patients in the home. ICU Medical, Inc. has acquired 84% of the common stock of Bio-Plexus, Inc. Bio-Plexus's principal products are blood collection needles designed to eliminate exposure to sharp, contaminated needles. ICU Medical's principal products are proprietary safe medical connection devices for use in intravenous therapy applications. Cepheid has received FDA clearance to market the IDI-Strep B test designed and developed by its joint venture partner, Infectio Diagnostic (IDI). The test runs on Cepheid's Smart Cycler instrument and is intended to be used to detect the presence of Group B Streptococcus in pregnant women at the time they enter labor and delivery. International Remote Imaging Systems has received FDA clearance to market its iQ 200 Automated Microscopy Analyzer. The iQ 200 is a urine microscopy analyzer based on the Company's proprietary image-based technology that uses digital images and neural network technology to analyze untreated urine specimens. The Leach Technology Group has developed a proprietary technology for a Lab-On-A-Chip analyzer that incorporates a range of modules for automated high-throughput handling, incubation and optical reading of microfluidic bio-chips. Applications of this technology include human and veterinary diagnostics (microbiology, clinical chemistry, immunology) and analytics (farm, food industry, environmental testing and agriculture). These applications are for both conventional and DNA-based methods. Luminex Corporation is collaborating with Bayer Diagnostics via a license agreement and related supply agreement for Luminex's proprietary xMAP technology, as well as a multi-year agreement relating to the development of a new cellular analyzer. The license agreement grants Bayer the right, under Luminex's patents, to develop and distribute in-vitro diagnostic products based on Luminex's proprietary xMAP technology. For these rights, Bayer Diagnostics will pay Luminex a one-time non-refundable license fee. Luminex also will receive royalties from the commercialization of future Bayer Diagnostics' products based on Luminex technology. The new cellular instrument is expected to target hospital and reference laboratories performing flow cytometry to monitor immunological status as well as hematological disease. Matritech, Inc. and Sysmex Corporation have formed a partnership to develop an automated Pap smear test based on Sysmex's flow cytometry technology and Matritech's patented NMP179 protein biomarker to perform cell-by-cell analysis for cervical cancer. OraSure Technologies Inc. has received FDA clearance to market its OraQuick Rapid HIV-1 Antibody Test. Abbott Laboratories Inc. will distribute the test to laboratory markets at hospitals and physicians' offices. Sales from OraSure to Abbott are expected to begin in January/February 2003. PDI, Inc. and PharmaNetics, Inc. have signed an agreement under which PDI will provide a sales team and post sales clinical support for PharmaNetics' ENOX Test, a rapid, point-of-care test to be cleared in the US to detect the anticoagulant effects of enoxaparin sodium. PerkinElmer, Inc. has received FDA clearance to market its NeoGram Phenylalanine Test System consisting of a reagent kit, application software and tandem mass spectrometer used in the identification of phenylketonuria (PKU) in newborns. The reagent kit is designed to run exclusively on tandem mass spectrometry equipment. Quantum Dot Corporation has launched its first Qdot product, the Qdot 605 Streptavidin Conjugate that comprises a multi-layered semiconductor nanocrystal attached to streptavidin. Currently supported applications include cell and tissue analysis. Quidel Corporation has introduced the UrinQuick Urine Chemistry Analyzer that provides advanced software capabilities and newly patented transport and optic systems. Quidel has also launched its QuickVue Advance pH and Amines test and the QuickVue Advance G. vaginalis test using the LTF (Layered Thin Film) platform. The United Nations Monitoring, Verification and Inspection Commission teams of UN biological weapons inspectors in Iraq are using Response Biomedical Corp's RAMP Systems to detect low levels of B. anthricis, ricin and botulinum toxin, in less than 15 minutes. Tm Bioscience Corporation is developing the Tm Tag-It Mutation Detection Kit for Coagulation. The test will be used to identify patients with an elevated risk of developing blood clots before considering surgery, hormone replacement therapy or hormone-based birth control methods. The company anticipates launching this product in early 2003 as the first in a series, which will also include tests for cystic fibrosis, melanoma, and drug metabolism. Vital Scientific NV has received FDA clearance to market the Fibron-1 blood clotting analyzer, together with related diagnostic assays and controls. The system performs the PT and PTT coagulation tests and was developed in collaboration with Biomedica Diagnostics, Inc.
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