China Medical's leukaemia FISH probe gets Chinese approval
This article was originally published in Clinica
Executive Summary
China Medical Technologies' Leukaemia BCR/ABL FISH (fluorescence in situ hybridisation) Probe has been approved by the Chinese state FDA (SFDA). The molecular diagnostic uses DNA probes to detect Philadelphia translocation, a chromosomal abnormality that is associated with chronic myelogenous, acute myelogenous and acute lymphoblastic leukaemias. This abnormality leads to the BCR and ABL genes fusing together to produce a defective protein called bcr-abl. Detecting the abnormality is important for guiding treatment for these different types of leukaemia – for example, Novartis' Gleevec inhibits the bcr-abl protein. Beijing-based China Medical already markets several FISH probes in China, including ones for prenatal abnormalities and cervical cancer, which were approved in January (www.clinica.co.uk, January 26 2009).
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