Genzyme Launches New Diagnostic Test for Common Blood Cancer
p53 Mutation Analysis Offers Critical Prognostic and Predictive Information for B-Cell Chronic Lymphocytic Leukemia
A significant number of patients with B-CLL have a dysfunctional p53 gene caused by mutations and deletions, and this number increases as the disease progresses. Studies show that p53 is a poor prognostic factor in B-CLL.
Currently, physicians generally test for p53 deletions using a technology known as "fluorescent in-situ hybridization" (FISH). FISH detects a deletion of a fragment of chromosome 17 that bears the p53 gene. However, B-CLL patients may have a p53 deletion, mutation, or both. Genzyme's new test is a gene sequencing assay that detects specific mutations in the p53 gene with a higher degree of sensitivity than FISH alone, thereby providing more comprehensive diagnostic information for high-risk patients. With the new availability of the p53 Mutation Analysis, Genzyme is expanding its diagnostic menu for B-CLL patients. The company also offers a minimal residual disease test, which detects very low levels of disease in B-CLL patients.
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