Overview

Acute Promyelocytic Leukemia (APL) is a rare but aggressive subtype of acute myeloid leukemia (AML-M3), characterized by a unique genetic translocation between chromosomes 15 and 17. This results in the formation of the PML-RARA fusion gene, which disrupts normal cell differentiation and drives leukemogenesis. APL is clinically significant because it requires urgent diagnosis and has a unique therapeutic response to ATRA (all-trans retinoic acid) and (ATO) arsenic trioxide. Rapid and accurate detection of the PML-RARA fusion transcript is therefore essential for diagnosis, treatment planning, and monitoring minimal residual disease (MRD). To address this critical need, Genes2Me offers the PML-RARA Real-Time PCR Kit, an advanced in vitro diagnostic solution designed for the qualitative and quantitative detection of PML-RARA fusion transcripts across all three isoforms: BCR1, BCR2, and BCR3.

The kit uses a one-step RT-qPCR protocol, where RNA from bone marrow or peripheral blood is reverse transcribed and amplified in a single reaction. Each isoform is detected with mutation-specific fluorescent probes - BCR1 (FAM), BCR2 (HEX), and BCR3 (FAM); while the ABL1 internal control (Texas Red) ensures assay reliability by validating RNA integrity and PCR performance. For quantitative analysis, the kit includes four calibrated Quantification Standards (QS1–QS4), enabling precise measurement of BCR1 transcript levels for MRD monitoring.