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 September 2001
AlleCure Corp. and BD Biosciences, a division of BD (Becton, Dickinson and Company) are collaborating to develop assays in support of AlleCure's AlleVax treatments for allergies and various autoimmune diseases. The collaboration focuses on the development of laboratory tests that may be used for allergy diagnosis, confirmation of vaccine efficacy, and continued patient monitoring before, during and after immunotherapy.
Carter-Wallace Inc., has received FDA clearance to market its blood test for Lyme disease to be marketed under the PreVue trade name. The test comes in a cassette that requires a drop of blood and a half-hour wait at a doctor's office or hospital. This is an upgrade of a lab-based test which does give false-positive results for those with other tick-borne infections, or other illnesses such as syphilis.
Chromatics Color Sciences International, Inc. has received FDA clearance of its upgraded ColormateTLc-BiliTest System for non-invasive monitoring of infant jaundice. The upgrade includes faster, more user friendly test programs that also provide test result transfer capability to a central server via the internet.
Fisher Scientific International, Inc. has signed a definitive agreement to acquire Cole-Parmer Instrument Company in a $205 million cash transaction. Cole-Parmer reported fiscal 2001 revenues of approximately $170 million and is a global manufacturer and distributor of specialty instruments, equipment and supplies to the scientific-research and industrial markets.
LifeScan, Inc., a Johnson & Johnson company, has received FDA clearance to market its new Harmony INR Monitoring System for anticoagulation blood monitoring. The system consists of a handheld electronic monitor and disposable, single-use test strips for prothrombin time testing. The company has also signed an exclusive US. marketing agreement with St. Jude Medical, Inc. to promote the Harmony system. The system is expected to be available for purchase in 2001 for the professional and home care markets.
Nanogen, Inc. has completed internal validation of a DNA-based protocol for Factor V Leiden for use in academic and other research laboratories on the NanoChip Molecular Biology Workstation system. This is the company's first protocol aimed at allowing researchers to bridge the gap between genomics research and clinical diagnostics.
Northfield Laboratories Inc. has submitted a Biologics License Application to the FDA for PolyHeme, a blood substitute for human use. Through its BLA, Northfield is seeking approval to manufacture and market its patented blood substitute product, PolyHeme, as an ideal oxygen-carrying resuscitative fluid for use in the treatment of urgent, life-threatening blood loss. PolyHeme can be given to any individual without the need for compatibility testing. It has a shelf life in excess of 12 months and is pathogen free.
Sensors for Medicine and Science, Inc. (SMSI) is developing a chemical sensing technology for medical diagnostic, consumer and industrial applications. The company's optical technology is used to develop an implanted, rice-grain sized, continuous glucose monitor that is remotely powered and interrogated. Initial pre-clinical testing of the device has demonstrated in vivo proof-of-concept over an extended time period. The device is moving into full-scale pre-clinical testing. Also in the works is a fast response oxygen sensor that enables real time analysis for critical care, respiratory function and metabolic applications. This application is currently in field-testing, with full commercialization planned for 2002.
Techlab, Inc. has received FDA clearance of the IBD-CHEK; a test for elevated levels of fecal lactoferrin an indicator of intestinal inflammation. This non invasive diagnostic test can be used in the diagnosis of inflammatory bowel disease versus irritable bowel syndrome.
Vascular Technologies has developed the Vein Entry Indicator Device (VEID) to eliminate the risks of traditional venipuncture. VEID is attached to a standard catheter unit. As a needle penetrates a blood vessel, the VEID emits a continuous beeping signal, which ceases if the needle exits the vein.
Xtrana Inc. has signed an exclusive five-year agreement with Alpha Laboratories Ltd. for the distribution of Xtra Amp Nucleic Acid Extraction kits and its hemostasis product line in the United Kingdom and the Republic of Ireland.
Product developments - Summer 2001
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Last modified: October 01, 2001