AroCell has already in 2008 developed prototype of an ELISA test. This method has been used for several internal evaluations and for one external evaluation in collaboration with the Academic Hospital in Uppsala. Two clinical application areas were evaluated – breast cancer and prostate cancer – and the results for breast cancer have been published (L Carlsson et al, Ups J Med Sci. 2009; 114(2):116-20). Development of a commercially viable ELISA started in May 2009 in collaboration with an external partner. We have today a well working assay for hematological cancers, which fulfils most of the technical and clinical criteria according to the “Design Goals” that were defined before start of the development process. In addition the test correlates excellently with the commercially available TK activity test (see below). TK 210/hem ELISA has already been introduced as a RUO (Research Use Only) product. A CE-labeled product is estimated to be launched by the end of 2012.
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