PML-RARA Real Time PCR Kit

Qualitative Detection & Differentiation of PML-RARA Fusion Transcripts (bcr1, bcr2, bcr3) in Acute Promyelocytic Leukemia

The PML-RARA-Q Real-Time PCR Kit is a CE-IVD molecular diagnostic assay designed for multiplex detection and differentiation of PML-RARA fusion transcripts, the defining genetic abnormality in Acute Promyelocytic Leukemia (APL).

This assay enables rapid molecular confirmation of APL, supporting early initiation of life-saving targeted therapy and timely clinical decision-making through a standardized real-time RT-PCR workflow.

Product Overview

The PML-RARA-Q Real-Time PCR Kit is an in vitro diagnostic (IVD) assay based on real-time RT-PCR technology for the qualitative detection of PML-RARA fusion transcripts in human clinical samples.

APL is characterized by a chromosomal translocation: t(15;17) → PML gene (Chr 15) + RARA gene (Chr 17)

This fusion results in three clinically relevant breakpoint isoforms, all covered by the assay: bcr1, bcr2 (Variant form) and bcr3.

Why PML-RARA Testing Matters

Acute Promyelocytic Leukemia (APL) is a distinct subtype of AML (AML-M3) requiring urgent molecular diagnosis due to its association with life-threatening coagulopathy.

Detection of PML-RARA fusion transcripts is essential to:

Breakpoint distribution:

Targets Detected

Fusion Transcript Targets
  • PML-RARA bcr1 (Long form)
  • PML-RARA bcr2 (Variant form)
  • PML-RARA bcr3 (Short form)
Internal Control
  • ABL1 gene
    Ensures RNA quality and assay performance validation.

Applications

The kit is ideal for clinical molecular laboratories performing:

RT-PML-RARA
  • PML-RARA fusion transcript testing
  • Molecular confirmation of Acute Promyelocytic Leukemia (APL)
  • Breakpoint isoform differentiation (bcr1 / bcr2 / bcr3)
  • Leukemia subtype classification
  • Oncology molecular diagnostic workflows
  • Rapid therapy-guiding genetic testing

Key Features & Benefits

Multiplex Detection of All Major PML-RARA Isoforms

Single assay detects and differentiates bcr1, bcr2, and bcr3 transcripts for comprehensive APL confirmation.

Rapid Molecular Confirmation of APL

Supports urgent diagnosis where early therapy initiation is clinically critical.

Three-Tube Multiplex Real-Time PCR Design

Isoform-specific ready mixes enable precise breakpoint identification.

Internal Control for Quality Assurance

ABL1 validates extraction, amplification, and sample integrity.

Automated Sample-to-Result Workflow

Compatible with Genes2Me rapid PCR platforms for streamlined molecular oncology testing.

Sample Types & Reporting Output

Sample Types

Validated for use with:

  • Peripheral blood (EDTA)
  • Bone Marrow (EDTA)
Reporting Output

The assay provides clear qualitative reporting, including:

  • Isoform-specific Positive / Negative result
  • Ct values
  • Amplification curves
  • Internal control validation
  • Exportable reports (USB / Bluetooth; system dependent)

Compatible System

OnePCR-Rapi-Q Ultra-Fast POC System

Designed for automated workflow including extraction and amplification.

OnePCR® workflow
  • Collect peripheral blood / bone marrow sample
  • Load 200 µl sample into Cartridge-1
  • Reconstitute Ready Mix tubes (bcr1 / bcr2 / bcr3)
  • Insert cartridges / tubes into system
  • Automated RNA extraction + RT-PCR amplification
  • Results displayed with isoform differentiation and Ct curves

Storage & Stability

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
PML-RARA-Q Real-Time PCR Kit G2M708821R G610024-3 24 Tests

Why Choose the PML-RARA-Q Real-Time PCR Kit?

If your lab requires a reliable APL molecular diagnostic PCR kit, this assay delivers:

  • multiplex detection of bcr1, bcr2, bcr3 isoforms
  • rapid confirmation of PML-RARA fusion
  • internal control-validated results
  • probe-based high-specificity PCR chemistry
  • compatibility with fast automated PCR systems
  • suitability for urgent leukemia diagnostics

Resources to get started

Download useful documents and technical information for the PML-RARA Real Time PCR Kit.

Product Brochure
IFU (Instructions for Use)
Report File

Product Enquiry Form

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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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