BloodCenter of Wisconsin today announced the availability of BCR-ABL Kinase Domain Mutation Analysis, a new DNA sequencing assay designed to help oncologists develop appropriate therapeutic strategies tailored to the specific needs of patients with chronic myeloid (or myelogenous) leukemia (CML).

The American Cancer Society estimates that physicians will diagnose approximately 5000 new cases of CML in the U.S. in 2008, and the National Donor Marrow Registry reports that more than 20,000 Americans currently have CML. Nearly all CML patients have a genetic abnormality known as BCR-ABL, and most CML patients are treated with Gleevec (imatinib; STI571), a targeted therapy that directly inhibits the molecular cause of the blood-borne cancer.

Unfortunately, clinical research has shown that a significant proportion of CML patients eventually develop resistance to Gleevec, resulting in a significant reduction in the drug's effectiveness. By detecting clinically important abnormalities, known as BCR-ABL kinase domain mutations, the BCR-ABL Kinase Domain Mutation Analysis will help physicians determine appropriate therapies for their patients. For example, based on the quantitative results generated by BCR-ABL Kinase Domain Mutation Analysis, a physician might prescribe a higher dose of Gleevec, alternative targeted kinase inhibitors or other therapeutic agents to manage the cancer.

"Oncologists are fortunate to have a variety of treatments available for leukemia patients, and molecular assays that clarify the genetic abnormalities of the disease are crucial to allow us to recommend the most appropriate treatment for a patient with CML," said Mark Juckett, M.D., director of the leukemia program at the University of Wisconsin Hospitals and Clinics. "BloodCenter of Wisconsin has once again provided the global cancer community with an important tool that will enhance patient care."

"BCR-ABL Kinase Domain Mutation Analysis is a natural outgrowth of our expertise in molecular diagnostics for oncology, dating back to the mid-1990s when we first performed molecular detection of the chimeric BCR-ABL gene," said Dan Bellissimo, Ph.D., director of the Molecular Diagnostics Laboratory at BloodCenter of Wisconsin. "Our teams seek to be at the forefront of the 'personalized medicine' revolution, and BCR-ABL Kinase Domain Mutation Analysis will help CML patients around the world receive individualized state-of-the-art therapy."

"BCR-ABL Kinase Domain Mutation Analysis is an early example of the type of laboratory test that allows us to 'fine tune' the administration of targeted therapies to treat specific cancers," said Roger Klein, M.D., J.D., medical director of BloodCenter of Wisconsin's Molecular Oncology Laboratory. "Assays like these will increasingly contribute to improved therapeutic approaches that offer both greater effectiveness and fewer side effects."

CML accounts for 20 percent of all leukemias affecting adults in the U.S. Most CML patients are middle-aged, but the cancer can occur in younger patients as well. For more information about CML, leukemias and current treatment options, visit the American Cancer Society's website at cancer.

About BloodCenter of Wisconsin

BloodCenter of Wisconsin is a private, non-profit organization widely acclaimed as one of the top transfusion medicine organizations in the world and a leader in diagnostic testing of blood, blood research and blood collection. BloodCenter of Wisconsin is the only provider of blood to over 50 hospitals, including every community hospital in southeastern Wisconsin. It is also one of only four blood centers in the United States with a significant blood research program. Its Blood Research Institute (BRI) is devoted solely and uniquely to blood-related research.

Diagnostic Laboratories develop and perform highly specialized tests on patient samples from throughout the United States and the world. The highly specialized testing and expert medical consultation provided by the Diagnostic Laboratories benefit patients in need of bone marrow or organ transplants, patients with bleeding and clotting disorders and patients with immunologic, neoplastic, or genetic diseases. Customers rely on the services offered by BloodCenter's Diagnostic Laboratories for expert assistance in solving complicated clinical issues.

BloodCenter of Wisconsin advances patient care by delivering life-saving solutions grounded in unparalleled medical and scientific expertise.

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