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 December 2003
Abbott Laboratories and i-STAT Corporation have entered into an agreement and plan of merger for Abbott to acquire all of the issued and outstanding stock of i-STAT.
DH Denmark Holdings ApS, a newly formed Danaher subsidiary has offered to buy Radiometer A/S for Dkr4.4 billion ($730 million).
Gen-Probe Incorporated has received FDA clearance to market its APTIMA COMBO 2 assay, for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhoeae on the TIGRIS DTS System. Gen-Probe and Tosoh have entered into a cross-license agreement. Tosoh will receive non-exclusive rights to Gen-Probe's transcription-mediated amplification and ribosomal RNA technologies. Gen-Probe will gain access to Tosoh's TRC amplification and INAF detection technologies for use with real time TMA.
Meridian Bioscience, Inc. has introduced two new POC tests. Meridian has begun marketing Influenza A&B Test that differentiates between the A and B strains of influenza. Also the company has received FDA clearance to market ImmunoCard STAT! HpSA, for the diagnosis of Helicobacter pylori infection in children and adults.
Pacific Biometrics, Inc. has been named the exclusive testing site in North America for the proprietary arthritis marker CartiLaps, ELISA, which detects fragments of type II collagen in urine. developed by Nordic Bioscience Diagnostics A/S. The test will be offered exclusively in North America by PBI through its central laboratory.
Panacea Pharmaceuticals, Inc. signed a License & Service Agreement with SRL, Inc. to develop and commercialize cancer diagnostic tests in Japan. The tests will be based on Panacea's HAAH Oncology Program, which targets the enzyme human aspartyl (asparaginyl) Beta- hydroxylase (HAAH). The non-exclusive license in Japan will allow SRL to commercialize HAAH- based tests using immunohistochemistry, immunocytochemistry, fluorescent in situ hybridization, ELISA, and quantitative reverse transcriptase polymerase chain reaction.
Spectral Diagnostics Inc. and a group of investors led by the Canadian Medical Discoveries Fund Inc. have established a joint venture company, IDx Inc. that will develop rapid assays for certain infectious diseases. Spectral will contribute a nominal amount of cash and intellectual property valued at $2 million in consideration for a 50% equity interest in IDx.
Tetracore, Inc. has received FDA clearance to market for RedLine Alert, an antibody-based test kit for use as an aid in the clinical laboratory identification of Bacillus anthracis colonies from culture plates. The test is a lateral flow immunoassay containing a monoclonal antibody which is specific for the presence of a cell surface protein found in Bacillus anthracis vegetative cells. The test can be used on colonies as early as 12 hours old.
Trinity Biotech plc has received FDA clearance to market its Uni-Gold Recombigen HIV test. The product is approved for the detection of antibodies to HIV in human serum, plasma or whole blood.
TriVirix, a contract manufacturer of electronic medical and life sciences equipment has acquired the assets of UMM Electronics, a company specializing in the design and development of medical device products. UMM Electronics, which previously operated as part of Leach Technology Group, will assume the TriVirix name and immediately begin operating as a wholly-owned subsidiary. UMM has manufactured more than two million medical devices and instruments in its 16 year history.
Product developments - November 2003
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