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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 June 2002
Dear Reader, we thank you for your continued support. As is our custom, we are taking a short summer break and will be back in September with our monthly updates. Take care, enjoy the summer. See you in September. Abbott Labs/MediSense has developed will highlight new research related to its Precision Xtra Advanced Diabetes Management System, that includes blood tests for glucose and ketones. Abbott is also expanding its IVD efforts. Abbott and Celera Diagnostics have formed a strategic alliance to develop, manufacture and market molecular diagnostic products to detect and manage infectious diseases and chronic conditions such as cardiovascular and autoimmune diseases, central nervous system disorders and cancer. Abbott and OraSure Technologies have signed an agreement for the co-exclusive distribution of OraSure Technologies' OraQuick rapid test for HIV-1 and for a non-exclusive sublicense of certain lateral-flow patents for which Abbott is the exclusive licensor. On May 11, 2002, OraSure received notification from the FDA that its application for blood sample testing was approvable. OraSure intends to file an application for use of the device with oral fluid specimens later in 2002. Avitar, Inc. has launched ORALscreen OSR, an instrument which automates the analysis of the ORALscreen rapid drugs-of-abuse test. In addition, test results can be stored and transmitted to remote locations. Bayer Diagnostics is launching Ascensia as the new global brand identity for its Glucometer products. Bio-Rad Laboratories, Inc. has granted Nanogen, Inc. a non-exclusive license to the C282Y and H63D mutations of the Hereditary Hemochromatosis HFE gene for use on Nanogen's NanoChip System. Calypte Biomedical Corporation has signed a worldwide non-exclusive distribution agreement with Adaltis Inc. (formerly known as Biochem Immunosystems Inc.) for the distribution of Calypte's serum HIV-1 Western Blot test. Calypte has also signed an agreement with Marukin Diagnostics, Inc. for the distribution of Marukin's urinary bile acid sulfate (UBAS) assay, a marker of liver function. The agreement gives Calypte exclusive rights to market Marukin's assay to the insurance industry in the United States and Canada. co.don Tissue Engineering, Inc. has developed osteocode pro, a cell-based test for osteoporosis. The test indicates cellular and molecular pathologic alterations of the tissue-generating cells of bone. The company also markets osteocode med, a patient-specific test to investigate the effect of drugs treating osteoporosis. Corgenix Medical Corporation has entered into a strategic collaboration with Genesis Bioventures, Inc. to develop an ELISA format of GBI's patented Mammastatin Serum Assay for breast cancer risk assessment. Cybersensors Ltd is developing an implanted glucose sensor that uses a combination of miniature wireless (RF) microchip technology with both conventional and novel sensors. The RF microchips feature a complete radio and antenna and are capable of operating without a battery. In addition, the company has developed polymer-based sensing technologies as the detection component. Ekips Technologies, Inc., announced today the company has received a $100,000 Phase I grant from the National Science Foundation to support the development of the Breathmeter, a laser-based breath analysis instrument that can be used to diagnose chronic illnesses such as asthma. EXACT Sciences Corporation and LabCorp have entered an exclusive, long-term partnership to commercialize PreGen-Plus, EXACT Sciences' test for the early detection of colorectal cancer. The introduction of PreGen-Plus, expected in the first half of 2003. HandyLab, has announced that its microfluidic testing system used for a disposable genotyping tests for infectious diseases is now entering pre-clinical trials. iMetrikus, Inc., and Polymer Technology Systems have entered a joint marketing agreement which calls for the integration of cardiac profiling and diabetes monitoring data collected from PTS' CardioChek device into MediCompass, iMetrikus' platform for chronic care management. IMI International Medical Innovations Inc. has received FDA clearance to market the Cholesterol 1,2,3 non-invasive skin cholesterol test system. Further the tests is not subject to a separate review under CLIA because CLIA requirements do not apply to skin analysis tests. The Institut Pasteur has transferred to F. Hoffmann-La Roche Ltd. the HPV intellectual property estate of Institut Pasteur. The transfer includes the cross license agreement to Digene relating to HPV types 35, 43 and 56 and has a license to U.S. and foreign patents relating to HPV types 33, 39 and 42. The transaction between Institut Pasteur and Roche does not include rights to Digene's intellectual property relating to HPV types 52, 58 and 68 or U.S. patent 5,057,411 (Type-Specific Papillomavirus DNA Sequences and Peptides) and other HPV-related intellectual property. LifeScan, Inc., has formed two strategic alliances. One is with Medical Automation Systems, Inc., integrating LifeScan's DataLink with RALS-Plus, and a second with TELCOR Inc., integrating DataLink with QML (Quick Multi-Linc). Litron Labs has developed a flow cytometry method to assess person's risk for cancer based on the analysis of DNA damage in the most newborn of human blood cells, obtained from a finger stick. Litron is also developing a system to detect MN-containing erythrocytes (MN-RBCs) that are infected with the malaria parasite, Plasmodium berghei. M-Biotech is developing an implanted glucose biosensor based on its patented glucose-responsive hydrogel technology. The implanted sensor will last for up to six months and can be replaced on an out-patient basis. The system includes a pager-like alarm monitoring device that displays glucose levels to the patient, and alerts them when the levels are not safe so corrective action can be taken. Morewood Molecular Sciences Inc. an immunoassay to detect Activated Protein C (APC) resistance in blood plasma using fluorescence detection methods. APC resistance is often implicated in thrombosis and a variety of pregnancy dysfunctions, including preeclampsia. Nanogen, Inc. has entered into a Development Site Agreement with the CDC and will shortly begin installation of a NanoChip Molecular Biology Workstation at the CDC's Foodborne and Diarrheal Diseases Branch in Atlanta, Georgia. The goal is to develop methods for simultaneously detecting specific strains of diarrheal E. coli and other pathogens on the NanoChip System. In exchange, Nanogen will receive certain licensing and commercialization rights to the assays developed by the CDC. Nanogen, Inc. has also launched an ASR test for the detection of the 25 gene mutations most commonly associated with cystic fibrosis. Pheromone Sciences Corp. has signed a Letter of Intent (LOI) for the exclusive distribution of Pheromone's PSC Fertility Monitor in Boots Company PLC across the United Kingdom over a three-year period. Phylos has received a Phase II SBIR grant from the National Institute of Allergy and Infectious Disease to develop a multiplex cytokine array using Phylos' TRINECTIN binding proteins as capture and detection agents. Roche Diagnostics has received FDA clearance to market its Accu-Chek Pocket Compass Diabetes Care Software, which tracks trends in blood glucose levels by storing and analyzing up to 1,000 blood glucose readings. Starplex Scientific Inc. and American Bio Medica Corporation have received FDA clearance to market Startox, an on-site point of care drugs of abuse test device. Startox is a completely self-contained sample collection and analysis device that detects the presence of cocaine, opiates, THC, PCP, and amphetamines simultaneously. The device uses a sample cup designed by Starplex, and patented membrane strips developed by ABMC. TheraSense, Inc. has launched its data and diabetes management program, called the FreeStyle CoPilot Web-Based Data Management System. Developed with Control Diabetes, Inc. and accessed via a secure Internet site, this program allows analysis and communication of glucose levels by healthcare providers and people with diabetes. Veinomed Limited has developed Vein-o-Spot, a computerized low noise I.R scanning device that can calculate the depth and diameter of all available veins but also, then, indicate with a light spot, the optimum vein to take a blood sample.
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