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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 2000
Abbott Laboratories, MediSense Products has received FDA clearance to market Sof-Tact, an automated glucose monitor that offers lancing, blood collection and glucose testing with a single press of a button. The system also allows users to draw a blood sample from less sensitive areas of the body such as the forearm or upper arm. The system follows the recent launch of Precision Xtra that measures blood glucose and blood ketone levels. The Sof-Tact system will be called Soft-Sense in Europe. Accelr8 Technology Corporation has acquired OpTest technology from DDx, Inc. The OpTest platform can be used in portable systems for rapid detection and quantification of molecular and microscopic scale affinity binding events. The potential applications include infectious disease and bacterial testing and nucleic acid studies. Avitar, Inc. has launched ORALscreen 2 that identifies the presence of cocaine and marijuana in oral fluid. Bayer Diagnostics has introduced its VERSANT HCV Qualitative RNA Assay in Europe. The test is based on transcription mediated amplification (TMA). Qualitative testing for HCV using TMA technology is available in the U.S. as a service of the Bayer Reference Testing Laboratory. Beckman Coulter, Inc. has received FDA clearance to market the Access Testosterone, for the quantitative determination of total testosterone levels in human serum and plasma. The test is designed to run on the Access Immunoassay System. Biosite Diagnostics has received FDA clearance to market its Triage BNP, that detects levels of BNP, or B-type natriuretic peptide, that rises in the blood during heart failure. The test is intended to help doctors decide whether a patient who is short of breath is suffering from congestive heart failure. The 15-minute test will cost about $30. Calypte Biomedical Corporation is collaborating with the Osborn Scientific Group to develop two urine-based rapid HIV antibody tests. Once the assays are completed and have received regulatory clearance, Calypte and Osborn expect the products to be the first urine-based rapid HIV antibody tests. Calypte already produces the only FDA cleared HIV-1 antibody urine tests. Earlier in the month, Calypte Biomedical Corporation became the distributor of Marukin Diagnostics Inc. Urinary Total Bile Acid Sulfate (UBAS) Assay in the insurance markets of the United States and Canada. Sulfated bile acid in urine is a useful marker for evaluating liver function. CompuCyte Corporation has been granted an exclusive license by the University of Florida Research Foundation for its patented monocyte-platelet complex (MPC) blood test for very early detection of acute myocardial infarctions. The test measures elevated levels of complexes of two types of blood cells: monocytes and platelets that have aggregated and are circulating in the bloodstream. The MPC test is an indicator of platelet activation, or the readiness of platelets to participate in clotting -- a cause or contributing factor in up to 90% of all heart attacks and strokes. CompuCyte is developing a commercial version of the test for use on its OnCyte Diagnostic System. CytoLogix Corporation has been awarded a Phase II SBIR grant from the National Cancer Institute for the development of a technology for providing on-slide controls for clinical immunohistochemical assays. The technology will provide clinical immunohistochemistry laboratories with a practical and simple means to check assay performance. The same controls will also serve as inter- laboratory standards, facilitating comparisons of assay performance DAKO Corporation has officially launched ImmunoCyt, an FDA-cleared cytopathology diagnostic test for the early detection of recurrent bladder cancer, developed by DiagnoCure. ImmunoCyt is intended for use by pathologists in conjunction with classic urine cytology and cystoscopy. Genomic diagnostic services company, Dianon Systems Inc. has agreed to sell and distribute Response Genetics' Danenberg tumor profile system in the U.S. The Danenberg Tumor Profile helps select chemotherapeutic agents based upon the genetic profile of the patient's tumor. In addition, the technology can be performed on formalin-fixed, paraffin-embedded tissue, which is the standard way almost all biopsies and surgical pathology specimens are processed today. Enteric Products, Inc., a wholly-owned subsidiary of E-Z-EM, Inc., has received FDA clearance for its PP-CAP IgA enzyme immunoassay that detects H. pylori IgA antibodies. The kit will be marketed both directly and through Sigma Diagnostics and Alexon-Trend in the United States and Europe and in Japan through Kyowa Medex Co. Ltd. GeneLink Inc. is collaborating with HealthScreen America to offer individuals the opportunity to store their DNA which will be routinely checked as genetic tests are developed for conditions such as breast cancer, Alzheimer's, Parkinson and diseases yet unknown. GeneLink has FDA approval and patents pending for its collection kit. GeneLink also has a distribution and supply contract with LifeLink Genetics, Inc. to provide this same service to the deathcare industry, specifically focusing on the cremation and cemetery business. Hypertension Diagnostics Inc. has received FDA approval to market its CVProfilor DO-2020 cardiovascular profiling system to non-invasively screen patients for the presence of cardiovascular disease. The system uses HDI's patented blood pressure waveform analysis technology to provide an assessment of arterial elasticity. Luminex Corp. and One Lambda Inc. are developing tissue typing Human Leukocyte Antigen-based applications on the Luminex LabMAP technology. Medical Research Group has begun human trials of its long term implantable glucose sensor and implantable insulin pump that together comprise the hardware of the MRG artificial pancreas. The sensor is implanted intravenously and the insulin pump is implanted in the abdomen. The sensor's output provides continuous readings of blood glucose levels, but does not yet control insulin delivery. OraSure Technologies Inc. has received a $1 million grant from the National Institutes of Health to develop a test for syphilis using either blood or oral fluid samples. The tests will be performed in a laboratory using the same procedures that are used with OraSure HIV samples. PE Corporation announced that its name change to Applera Corporation was in effect as of November 30, 2000. This new name is a combination of the names of the company's two operating businesses, the Applied Biosystems Group and the Celera Genomics Group. The PE Biosystems Group name change to the Applied Biosystems Group was also in effect on November 30. Qiagen and Luminex has signed an agreement whereby Qiagen will market kits based on Luminex technology. The companies will also combine Qiagen's instrumentation platform with the Luminex LabMAP Detection Technology. Qiagen intends to launch its first line of reagents and assay kits based on the Luminex technology in the third quarter of 2001. The initial products are expected to combine Qiagen's proprietary and leading protein expression and purification technologies with Luminex's detection platforms. Quantimetrix Corporation has developed the Lipoprint System, which provides much more, in-depth information about LDL and HDL cholesterol subfraction levels. The system measures seven LDL subfractions, which are critical in determining if an individual has an LDL subfraction profile that is associated with increased risk of coronary artery disease. Quidel Corporation has introduced the new QuickVue H. pylori gII test. Quidel has also signed a definitive agreement to acquire Litmus Concepts Inc. for 3.25 million shares of Quidel common stock. Saliva Diagnostic Systems, Inc. and Chembio Diagnostic Systems have signed of a letter of intent to merge. The merger is contingent upon approval by each company's board of directors and stockholders and upon SDS ability to reduce its liabilities to agreed-upon levels. In the interim, SDS has entered into a manufacturing and supply agreement with Chembio to produce its products. Virco is developing a test that detects whether the MGMT gene, has a methyl moiety attached to it. Alkylating drugs work by attaching to the genes in cancer cells, causing various changes that lead to the death of the cancer cell. However, if the MGMT gene has no methyl group, it can switch on a repair process, thereby counteracting the effect of the alkylating drug and the patient is unlikely to respond to treatment. ZymeTx and Polaroid have formed a strategic alliance to jointly develop an instant image-based platform detection system for the rapid diagnosis of influenza, with follow-on applications to other viral diseases.
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