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 January 2002
Abbott Laboratories received FDA clearance to market announced its Vysis PathVysion HER-2 DNA Probe Kit for use in identifying women with metastatic breast cancer who could benefit from Herceptin therapy.
Acolyte Biomedica is developing a rapid automated microbiology system to detect infectious diseases within a few hours. The system uses bioluminescent detection technology, immuno magnetic extraction technology, and antibiotic susceptibility testing to detect bacterial infections and assesses their susceptibility to select antibiotics within hours.
AP Genomics is developing the Dengue Diagnostic Kit that tests for the presence of dengue DNA in a blood sample and will indicate which one of four types of the virus is present within hours. The kit will be commercially available by the third quarter of 2002. AP Genomics, is also working on DNA test systems for other diseases including malaria.
Beckman Coulter, Inc. has acquired Avocet Medical, Incorporated for $3 million. The transaction gives Beckman Coulter all rights to Avocet's patented AvoSure POC prothrombin time system.
Bio-Rad Laboratories, Inc. has introduced a new CDT TIA Test Kit. CDT, (Carbohydrate-Deficient Transferrin) is a specific biomarker for identifying heavy alcohol consumption.
Biosite Incorporated has received FDA clearance to market the Triage TOX Drug Screen a qualitative test for eight classes of commonly abused prescription drugs in urine.
ChromaVision Medical Systems, Inc. has formed an alliance with Richard-Allan Scientific Company, a subsidiary of Apogent Technologies Inc., to develop and market reagent kits and antibodies used in immunohistochemical testing on the Automated Cellular Imaging System (ACIS), worldwide.
Corgenix Medical Corporation will acquire Affinity Biologicals, Inc., a privately-owned Canadian company that manufactures antibodies and plasmas for use in coagulation assays. Corgenix will pay $2 million in cash, stock and notes payable. The acquisition is expected to close during the spring of 2002.
Cytyc Corporation has submitted a PMA Supplement to the FDA to allow testing for Chlamydia trachomatis and Neisseria gonorrhea directly from the ThinPrep Pap Test vial using Roche Diagnostics' COBAS AMPLICOR automated system.
Esoterix Infectious Disease Center has launched the HCV Complete hepatitis C program that includes: HCV Antibody (Anti-HCV), HCV Confirmed by RIBA, HCV RNA by PCR qualitative and quantitative, ALT (Alanine Aminotransferase) and HCVMap, a genotyping test developed by Visible Genetics.
Fujirebio Diagnostics, Inc. (Centocor Diagnostics) has introduced a new line of cancer immunoassays in microtiter format - CA 125II, CA15-3, CA19-9, CA72-4, total PSA, and free PSA. The assays were co-developed with Trinity Biotech and will be available in Southeast Asia in Q1 2002 and then in Latin America, the Middle East, and Eastern Europe.
Meretek Diagnostics, Inc., and Otsuka Pharmaceutical Company Ltd., Japan, have received FDA clearance to market the UBiT-IR300 infrared spectrophotometer, a POC instrument to perform the BreathTek Urea Breath Test for Helicobacter pylori infection. Marketing of the UBiT-IR300 is expected to begin soon after the pending FDA clearance of the BreathTek test kit.
Nastech Pharmaceutical Company Inc. has received FDA clearance to market its non-invasive, patented Mammary Aspiration Specimen Cytology Test device for potential early detection of breast cancer.
Quantech Ltd. has received FDA clearance to market the FasTraQ System and the PrePaQ Total hCG test cartridge. The FasTraQ system allows operators to perform multiple test panels on different patients simultaneously in 15 minutes or less.
Quest Diagnostics Incorporated and Nichols Institute Diagnostics have received FDA clearance to market the Bio-Intact PTH (1-84) test kit to measure parathyroid hormone. The test is designed for the Nichols Advantage automated benchtop chemiluminescence system.
Response Biomedical Corp. has received FDA clearance to market the RAMP Reader and RAMP Myoglobin Test.
A jury has awarded IGEN International, Inc. $505 million in damages in its case against Roche Diagnostics. The jury's findings permit IGEN to terminate its license agreement with Roche and confirms IGEN's right to Roche's Elecsys instruments and immunoassays. IGEN is also entitled to certain other technologies owned or developed by Roche.
Trinity Biotech Plc has received FDA clearance to market its Uni-Gold Strep. The test is already available internationally.
TriPath Imaging, Inc. has entered into a multi-year agreement with Dynacare Inc. whereby the companies will co-market the AutoCyte PREP and AutoPap Primary Screening Systems to clients throughout the US and Canada.
ZymeTx, Inc. has entered into a distribution arrangement with Advanced Laboratory Technologies, Inc., a company specializing in point-of-care diagnostic testing equipment, supplies and training for nursing home facilities in the US.
Product developments - December 2001
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