Cepheid Collaborates With Novartis on Chronic Myelogenous Leukemia

Cepheid today announced an exclusive collaboration with Novartis for the commercialization of a test for monitoring the BCR-ABL gene transcript in peripheral blood specimens from patients diagnosed with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). Together with other lab tests, monitoring levels of BCR-ABL transcripts in Ph+ CML patients will aid in patient management. The collaboration reflects the commitment shared by Novartis and Cepheid to deliver the benefits of an FDA-cleared/approved molecular test that reports results which are linked to an internationally accepted standard called the "International Scale" (IS). With the development of the class of drugs called tyrosine kinase inhibitors, Ph+ CML patients have access to the broadest range of therapeutic options ever available. A standardized molecular monitoring BCR-ABL test with greater reproducibility is expected to support optimal patient management decisions. By moving to a rigorously developed, regulatory-cleared/approved test which is also linked to the IS, the collaboration aims to reduce the variability that is currently inherent in BCR-ABL testing.