Gene Expression-based Array Accurately Diagnoses Lymphoma Subtypes

The median sensitivity was 98% and the median specificity was 85%. The overall accuracy rate of the array was estimated to be over 90% given that conventional pathologic diagnoses have an average error rate across all lymphoma subtypes of greater than 15%. Evaluation of the array involved 153 tumor samples from patients with clinically diagnosed lymphoma.

Med BioGene, Inc. (MBI; Vancouver, Canada), a life-science company focused on the development and commercialization of genomic-based diagnostic tests for cancer and cardiovascular disease, announced that the results from the study that confirm the high accuracy rate of LymphExpress Dx v.1.0. The company is currently developing a second-generation prototype, LymphExpress Dx v.2.0. This array will diagnose additional subtypes of lymphoma, in total representing approximately 98% of all non-Hodgkin B-cell and Hodgkin lymphomas.

Accurate diagnosis of lymphoma is essential for determining prognosis and the best treatment options, but this presents a clinical challenge as pathologists disagree regarding diagnosis of certain subtypes in as many as 47% of the cases. The experience and skill of the pathologist is of particular importance for accurate diagnoses. Conventional diagnosis can be time-consuming and requires the interpretation of results from a battery of complex tests to render a diagnosis of the particular lymphoma subtype. Molecular diagnostic tools, such as LymphExpress Dx, are expected to simplify and expedite the process while providing more accurate diagnoses.

MBI develops these tests by identifying the genes, or biomarkers, which indicate the presence of disease. The development of these tests is the first step towards personalized medicine and will replace the conventional "one drug fits all” approach to disease management.


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