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 March - April 2007
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Beckman Coulter introduced the Access Inhibin A, an automated assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma. Inhibin A is used as an aid in the diagnosis and monitoring of various reproductive hormonal disorders.
Bio-Rad Laboratories launched two Epstein Barr Virus (EBV) kits for use on its BioPlex 2200 system. The IgG kit includes assays for EBV VCA, EBV NA-1, and EBV EA-D, and the IgM kit includes assays for EBV VCA and heterophile antibodies.
Cepheid and Instrumentation Laboratory (IL) signed an exclusive development and distribution to develop a line of tests for hemostasis applications to be used on Cepheid’s GeneXpert System. IL will market these tests as a key complement to its panel of automated hemostasis diagnostic assays. The first tests will be the Xpert HemosIL Factor II and Factor V tests.
Diazyme Laboratories received FDA clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit for the quantitative determination of HbA1c in human whole blood samples. The HbA1c test uses two ready-to-use liquid stable reagents. Since it does not require a separate measurement of total hemoglobin content in the samples, the assay only needs a single channel to perform the test on chemistry analyzers in comparison with some immunoassays that require a separated measurement of total hemoglobin and need two channels for the test on chemistry analyzers.
Polymedco introduced its POC BTA stat test for the detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine.
SmartGene entered into a strategic collaboration with LabCorp. LabCorp will use SmartGene's advanced technology and integrated Web-based services to support more rapid and precise identification of bacterial and fungal pathogens.
Product developments - February 2007
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Last modified: May 04, 2007