PML-RARA Real-Time PCR Kit

Product Overview

Acute Promyelocytic Leukemia (APL) is a rare but aggressive subtype of acute myeloid leukemia (AML-M3), characterised by a unique genetic translocation between chromosomes 15 and 17. This results in the PML-RARA fusion gene, which disrupts normal cell differentiation and drives leukemogenesis. APL requires urgent diagnosis and has a unique therapeutic response to all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). Rapid and accurate detection of the PML-RARA fusion transcript is therefore essential for diagnosis, treatment planning, and monitoring minimal residual disease (MRD).

To meet this critical need, Genes2Me introduces 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 (long), BCR2 (variant), and BCR3 (short). Supporting both initial APL diagnosis and ongoing MRD monitoring, the kit empowers clinicians and laboratories to make timely, evidence-based treatment decisions with confidence.

Targets:
PML-RARA Fusion Transcripts: BCR1 (Long), BCR2 (Variant), BCR3 (Short)
Technology:
One-Step Real-Time RT-qPCR (TaqMan)
Detection:
Qualitative and Quantitative
Sample Type:
Bone Marrow, Peripheral Blood (RNA)
Certification:
IVD
PML-RARA Real-Time PCR Kit

How the Assay Works

The PML-RARA 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 using mutation-specific fluorescent probes: BCR1 (FAM), BCR2 (HEX), and BCR3 (FAM). An ABL1 internal control (Texas Red) validates RNA integrity and PCR performance in every run, ensuring assay reliability and minimising the risk of false-negative results. For quantitative analysis, four calibrated Quantification Standards (QS1–QS4) are included, enabling precise measurement of BCR1 transcript levels for MRD monitoring.

Clinical Relevance

PML-RARA fusion transcript testing is central to the diagnosis and management of APL. Detection of all three isoforms confirms APL diagnosis, while isoform differentiation between BCR1, BCR2, and BCR3 may influence prognosis and therapeutic response to ATRA and ATO-based regimens. Quantitative monitoring of BCR1 transcript levels enables clinicians to track disease progression and evaluate treatment efficacy over time. With high sensitivity and specificity for reliable detection even at low transcript copies, the PML-RARA Real-Time PCR Kit provides laboratories with dependable molecular diagnostic performance for both initial diagnosis and longitudinal MRD monitoring.

Sample Type & Reporting Output

Sample Type:
Bone Marrow, Peripheral Blood (RNA)
Reporting Output:
Qualitative detection and quantitative measurement of PML-RARA fusion transcripts (BCR1, BCR2, BCR3)
Targets Detected:
PML-RARA fusion transcript isoforms: BCR1 (Long), BCR2 (Variant), BCR3 (Short)

Key Features & Benefits

Comprehensive Isoform Coverage

Detects all three clinically relevant PML-RARA transcripts: BCR1 (long), BCR2 (variant), and BCR3 (short), confirming APL diagnosis across all translocation subtypes.

Dual Qualitative and Quantitative Functionality

Supports both qualitative detection for initial APL diagnosis and quantitative monitoring of BCR1 transcript levels for MRD assessment and treatment response evaluation.

Multiplex Assay Design

Isoform-specific probes — BCR1 (FAM), BCR2 (HEX), BCR3 (FAM) — and an ABL1 internal control (Texas Red) validate RNA integrity and PCR performance in every run, minimising false-negative results.

Quantification Standards

Four calibrated Quantification Standards (QS1–QS4) enable precise BCR1 transcript quantification for accurate and reproducible MRD monitoring.

Flexible Compatibility

Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio™ 5, Bio-Rad CFX96, Roche LightCycler® 480, and Genes2Me RapiCycler 96.

Fast and Streamlined Workflow

One-step RT-qPCR protocol with ready-to-use mixes minimises hands-on time, reduces the risk of errors, and delivers results efficiently.

Applications

  • Confident APL Diagnosis: Accurately detects all clinically relevant PML-RARA fusion transcripts, enabling rapid and definitive confirmation of acute promyelocytic leukemia (APL).
  • Informed Treatment Decisions: Differentiates between BCR1, BCR2, and BCR3 isoforms, supporting prognostic assessment and personalized therapeutic planning.
  • High Sensitivity & Specificity: Reliable detection even at low transcript copy numbers, supporting confident clinical reporting at all stages of disease.
  • Effective MRD Monitoring: Delivers quantitative insights to track disease burden, assess treatment response, and support timely clinical intervention.

Analytical Performance

  • High sensitivity and specificity for detection of all three PML-RARA isoforms: BCR1 (FAM), BCR2 (HEX), and BCR3 (FAM)
  • One-step RT-qPCR protocol combining reverse transcription and amplification in a single reaction for efficient sample processing
  • ABL1 internal control (Texas Red) validates RNA integrity and RT-qPCR efficiency in every run
  • Four calibrated Quantification Standards (QS1–QS4) enable precise BCR1 transcript quantification for MRD monitoring
  • Reliable detection even at low transcript copy numbers across bone marrow and peripheral blood samples
  • Compatible with QuantStudio™ 5, CFX96, LightCycler® 480, and RapiCycler 96 platforms

With the PML-RARA Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection and quantification of PML-RARA fusion transcripts. By supporting rapid APL diagnosis, isoform characterisation, and longitudinal MRD monitoring, the kit helps clinicians make informed decisions for patient care and disease management. Empower your laboratory with the PML-RARA Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report

PML-RARA Real-Time PCR_Amplification

PML-RARA Real-Time PCR specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
PML-RARA Real-Time PCR Kit G2M708821 G610024-1 50 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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