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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 2006
Dear Reader, the StratCom Team takes this opportunity to wish you the very best holiday season and a New Year of health and peace on earth. Thank you for your continued support. Best wishes, Shara Rosen Acolyte Biomedica has developed the BacLite rapid MRSA screening test, which gives a result in 5 hours direct from a swab providing a result in the same day as the specimen is taken. BacLite MRSA comprises two instrument units - a wash module and a read module - and a reagent kit for performing the test in microtitre plates. Bruker Daltonics and HealthLinx have discovered two biomarkers linked to pregnancy complications. The tests are based on Bruker’s ClinProt test, and may be used to diagnose women who are predisposed to pregnancy complications such as preeclampsia, pre-term labor, miscarriage, and gestational diabetes. Dade Behring signed a license and cooperation agreement with Euro-Diagnostica granting rights to Dade Behring for the use of cyclic citrullinated peptides (CCP) and the development of an automated anti-CCP test for use on Dade Behring's clinical laboratory instrumentation. Dade Behring launched its MicroScan Dried Gram-Negative Overnight and Synergies Plus Panels with Streamlined Extended Spectrum B-Lactamase (ESBL) tests for the confirmation of ESBL enzymes in Klebsiella pneumoniae, Klebsiella oxytoca, Escherichia coli and Proteus mirabilis. Digital Angel Corp. has received a patent for its blood glucose-sensing microchip that is implanted using a syringe. The implantable bio-sensor chip has a glucose sensor and circuitry that allows the user to scan it to determine their level of glucose concentration. The microchip transmits the data to a wireless scanner that displays the glucose level. The device is powered by the scanner signal, avoiding the need for a battery. IBEX Technologies is developing its C2C biomarker assay, a biomarker of cartilage degradation and re-modeling, a normal process that is found in children and adults with osteoarthritis (OA) and rheumatoid arthritis (RA). The C2C assay currently sold measures the amount of real-time collagen degradation in serum. IBEX plans to launch a urine-based C2C assay at the end of 2006. Instrumentation Laboratory has received FDA clearance to market its HemosIL homocysteine assay, for use on the company’s IL coagulation systems, rather than on an immunoanalyzer. Inverness Medical Innovations, and Vedalab S.A., settled their patent litigation, which has been ongoing in France and Germany since 1997. In addition Vedalab has granted to Inverness exclusive U.S. distribution rights to its products. Inverness has in turn granted Vedalab a royalty- bearing license under certain patents to manufacture its current products. Magellan Biosciences acquired TREK Diagnostic Systems. TREK will operate as a wholly owned subsidiary of Magellan and continue to market its products under the TREK Diagnostic Systems brand name. Matritech and Inverness Medical Innovations have agreed to commercialize Matritech's NMP22 BladderChek Test as a non-prescription or over-the-counter (OTC) test as an aid for the diagnosis and monitoring of bladder cancer. In the meantime, Inverness will begin supplying the point-of-care urine test that is used in the diagnosis of bladder cancer. Further, Inverness will become the exclusive U.S. distributor of the test to be sold through over-the-counter retail channels. Quotient Diagnostics is developing the Quo-Test, an automated homogenous assay system for HbA1c. The fluorescence quenching assay uses solid state opto-electronic technology. A desktop reader quantifies the concentration of HbA1c in the sample. Results are delivered in about three minutes from a blood sample of less than 5 µl. The starter kit contains a reader, barcode scanner, mini-printer, and a pack of 10 disposable cartridges.
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