Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)

Inclusion Criteria: * prospective specimens: * Patient is at least 18 years of age * Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states. * Patient has been diagnosed with CML. * Patient consents to provide at least 12 mL of peripheral blood for study purposes * frozen specimens: * Specimen is from a subject diagnosed with CML * Specimen meets the manufacturer's criteria to support testing by both diagnostic assays Exclusion Criteria: * prospective specimens: * Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider * Patient has been previously enrolled * frozen specimens: • Specimen previously enrolled