New diagnostic test for common blood cancer from Genzyme

Genzyme has announced the availability of its p53 Mutation Analysis for B-cell chronic lymphocytic leukaemia (B-CLL).

A tumour suppressor gene, p53 stops cell division when DNA damage is present. If the p53 gene does not function normally, genetic mutations in dividing cells remain unchecked, leading to the accumulation of abnormal, malignant cells.

Mutations in p53 are present in more than 50% of all human cancers, including colon, breast, lung, bladder, brain, liver and hermatological malignancies.

"It is well known that p53 mutations and deletions are associated with poor survival in B-CLL patients, said hematologist/oncologist Mark Goldberg, md and senior vp of clinical research at the company: "Genzyme's p53 Mutation Analysis will provide oncologists and their patients with additional important prognostic and predictive information and help them determine the best treatment options."

The new test from Genzyme is a gene sequencing assay that detects specific mutations in the p53 gene with a higher degree of sensitivity than fluorescent in situ hybridisation (FISH), the current standard test for p53 deletions.