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 2001
AltaChem Pharma Ltd. is buying the diagnostic unit of Cytovax Biotechnologies Inc. in order to access the Cytovax Accu-Mab kit for whooping cough diagnosis. The Accu-Mab device is specific for Bordetella pertussis and Bordetella parapertussis and is used mainly by public health laboratories and children's hospitals in Canada and the U.S.
Applied Biotechnology Group, an Applera Corporation business, has begun clinical trials of the ViroSeq HIV-1 Genotyping System for HIV-1 resistance testing of HIV-1 infected patients.
Bayer Corp. and BioReliance Corp. have launched an Western Blot assay that detects an abnormal form of prion protein, a marker for Transmissible Spongiform Encephalopathies (TSE), in biological products. Bayer has licensed exclusive commercialization rights for the assay to BioReliance for use in prion clearance validation studies for samples from the biopharmaceutical purification process. Many biopharmaceutical products are grown in media containing calf serum and some human-derived biological products contain bovine additives. Bayer is in the process of developing an assay for detection of the prion protein in humans.
Chiron Corp. has granted a worldwide, semi-exclusive license to Organon Teknika BV under Chiron's patents of HIV in assays for use in clinical diagnostics, excluding use in blood screening. The agreement enables OT to continue to manufacture and sell probe-based HIV diagnostic products, including its Nuclisens HIV-1 assays and to expand its product offerings in the field of nucleic acid sequence-based HIV assays.
Cytyc Corporation and Digene Corporation will promote human papillomavirus (HPV) testing with Digene's Hybrid Capture 2 HPV Test directly from Cytyc's ThinPrep Pap Test collection vial in the U.S.
IMI International Medical Innovations Inc. has received a medical device license for its skin cholesterol test, Cholesterol 1,2,3 from the Therapeutic Products Program (TPP) at Health Canada. The license allows IMI to market and sell Cholesterol 1,2,3 in Canada for risk assessment of coronary artery disease. Cholesterol 1,2,3 is a rapid, non-invasive test that measures cholesterol in the skin without requiring a blood sample.
Inverness Medical Technology, Inc. has completed its acquisition of Integ Incorporated and Integ has been merged into a subsidiary of Inverness Medical Technology. Inverness and Integ market diabetes glucose monitoring products.
IRIS - International Remote Imaging Systems, Inc. and VR Interactive Inc. are co-developing methods for 3-D immersive imaging that provides 360 degree photo realistic images in about 3 seconds using VR's SurroundPhoto software.
MiniMed Inc. and the Lawrence Livermore National Laboratory are developing an implantable device to monitor glucose levels in diabetes patients. The sensor would be imbedded under the skin of patients and would signal an insulin pump that administers insulin, when needed.
MEDTOX Scientific, Inc. subsidiary, MEDTOX Diagnostics, Inc., has received FDA clearance to market its PROFILE-ER device that provides a nine drugs-of-abuse panel, targeted at hospital laboratories for emergency response screening in drugs-of-abuse overdose situations - cocaine, amphetamines, cannabinoids, opiates, phencyclidine (PCP), benzodiazapine, barbiturates, tricyclic antidepressants (TCA) and methadone. The screen is a one-step process that produces qualitative results in seven minutes.
Six companies have formed the National Alliance for the Primary Prevention of Sharps Injuries, following passage of the new U.S. Needlestick Safety and Prevention Act. The founding companies are Venetec International, Cell Robotics International, Bioject Medical Technologies, ICU Medical Inc., ALARIS Medical Systems Inc. and Equidyne Systems Inc.
PharmaNetics, Inc. and Bayer Diagnostics have launched Rapidpoint Accent, a POC test system for coagulation testing and monitoring. Rapidpoint Coag test cards include the Heparin Management and Activated Partial Thromboplastin Time Tests as well as three different tests for Prothrombin Time (PT).
Pheromone Sciences Corp. is developing the PSC Fertility Monitor for detecting fertility and ovulation. The monitor is a wristwatch like device which predicts ovulation by measuring ion changes on the surface of the skin.
Product developments -December 2000
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Last modified: February 04, 2001