QXDx BCR-ABL %IS Kit (IVD/CE-IVD)

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Overview

Intended to monitor patients with Chronic Myeloid Leukemia (CML), this FDA-cleared ddPCR kit reports in both International Scale (%IS) and Molecular Response (MR).
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Description

Description

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The QXDx BCR-ABL %IS Kit is a digital PCR test that monitors the p210 BCR-ABL major translocation in the peripheral blood of patients with Chronic Myeloid Leukemia (CML). The test is designed and run on Bio-Rad's QXDx Droplet Digital PCR System, enabling precise, highly sensitive quantification of nucleic acids.

Features and Benefits

  • Absolute quantification — eliminates the need for standard curves
  • Simplified and scalable workflow — flexibility to evaluate 8 to 48 samples per run in a workflow as simple as qPCR
  • Direct reporting on International Scale (%IS) and Molecular Response (MR) values — provides standardized interpreted output


TESTIMONIAL Bio-Rad’s Droplet Digital PCR System is a powerful platform for monitoring patients being treated for CML. The increased sensitivity and precision of multiplexed BCR-ABL1 measurements as compared to qPCR, along with direct absolute quantification in target copies and no standard curves, lends to the rationale for ddPCR use in routine laboratory testing.

Niels Pallisgaard
Department of Pathology
Zealand University Hospital
Denmark




The QXDx BCR-ABL %IS Kit can be used with either one of Bio-Rad’s digital PCR systems FDA-cleared for use in regulatory/in vitro diagnostics (IVD)* environments:

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(Discontinued) QXDx BCR-ABL %IS Kit
12005660
Pkg of 1, digital PCR test for montoring patients with Chronic Myeloid Leukemia (CML)

Equipment

Equipment

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(Discontinued) PX1 PCR Plate Sealer
1814000
PCR plate sealer, includes heat sealing instrument, plate support block that holds 96-well and 384-well plates, sealing frame, power cord

Documents

Documents

Number Description Options
6989
QXDx™ BCR-ABL %IS Kit Flier, Ver A