THIS ASSAY DETECTS THE PRESENCE OF AN ABNORMAL CLONE TO INDICATE MALIGNANT NEOPLASTIC PROCESS. IT ASSISTS IN THE DIAGNOSIS AND CLASSIFICATION OF CERTAIN MALIGNANT HEMATOLOGICAL DISORDERS, EVALUATION OF PROGNOSIS, MONITORING EFFECTS OF THERAPY AND REMISSION. BONE MARROW SPECIMENS ARE PREFERRED OVER PERIPHERAL BLOOD.

THE T(9;22) IS A BALANCED TRANSLOCATION BETWEEN CHROMOSOMES 9 & 22 LEADING TO FUSION OF BCR & C-ABL GENES AND TO THE TRANSCRIPTION OF LEUKEMIA SPECIFIC BCR-ABL MRNAS. PHILADELPHIA (PH) CHROMOSOME CAUSING THE BCR/ABL FUSION, IS PRESENT IN APPROXIMATELY 95% CASES OF CHRONIC MYELOID LEUKEMIA (CML) AND 25-30% CASES OF ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). DUE TO DEVELOPMENT OF POTENT TYROSINE KINASE INHIBITORS & ANTI-SENSE THERAPIES, PRESENCE OF BCR/ABL TRANSLOCATION IS A FAVORABLE PROGNOSTIC MARKER.