Press Release: New Study Will Assess Accuracy and Reproducibility of Droplet Digital PCR for Monitoring Chronic Myeloid Leukemia Treatment Response

SHEFFIELD, UK. July 2019. The UK National External Quality Assessment Scheme for Leucocyte Immunophenotyping (UK NEQAS LI) today announced the participation of Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, in a study that will compare the efficacy of Bio-Rad’s Droplet Digital PCR (ddPCR) technology and established reverse transcription quantitative PCR (RT-qPCR) methods and for the measurement of the fusion gene BCR-ABL1 commonly associated with chronic myeloid leukemia (CML) progression.

The study will be conducted by the UK NEQAS LI, an External Quality Assessment and Proficiency Testing provider, based at Sheffield Teaching Hospitals.

Researchers will use Bio-Rad’s QXDx BCR-ABL %IS IVD kit to assess the accuracy and reproducibility of ddPCR for detecting the BCR-ABL1 fusion transcripts (e13a2 and e14a2) by comparing it to well established RT-qPCR methods. Measurement of this gene fusion is a surrogate biomarker for clinical outcomes in trials for new therapies and is embedded in standard patient management protocols.

“Working with NEQAS LI, we will rigorously test whether ddPCR is a more precise method for measuring this important clinical biomarker, and we expect that evidence from this study will help to guide adoption of new standards in Europe and beyond,” said Lisa Jensen-Long, Vice President of Marketing, Bio-Rad Digital Biology Group.

While RT-qPCR is the standard for monitoring BCR-ABL1, it has significant issues that potentially affect patient treatment, including inter- and intra-laboratory variation, bias, and variability, which all impact accuracy. This study has the potential to Illustrate that ddPCR can address these limitations by virtue of the generation of absolute quantification data points. Absolute quantification removes the need for external standards and thus any bias associated with their generation and use, as well as reducing the workflow requirements during plate setup. If these improvements can be demonstrated, ddPCR can be established as a more accurate and reproducible method for monitoring CML treatment response. 

"We hope that this collaboration can help establish digital PCR's ability to overcome some of the issues we have identified in the testing of BCR-ABL1 in recent years, ultimately improving patient treatment in CML," said Liam Whitby, Director of UK NEQAS LI.

This would also be the first definitive and large scale multicenter study effort to confirm whether ddPCR has a lower limit of detection than RT-qPCR as suggested by evidence from some other recent studies.

In this study, which is already underway, researchers from 28 major leukemia testing centers in Europe, Asia and the United States will compare ddPCR and RT-qPCR in testing the same 10 engineered cell line controls produced by NEQAS LI. The samples span a wide range of fusion gene levels, allowing the researchers to test the detection limits of the techniques.

More information about UK NEQAS LI is available on its website ukneqasli.co.uk. To learn more about ddPCR, visit bio-rad.com/digitalPCR.

Press Contact:

UK NEQAS LI

Stuart Scott, Centre Manager

+44 0114 267 3603

stuart.scott@ukneqasli.co.uk

Bio-Rad Laboratories, Inc.

Tina Cuccia, Corporate Communications

510-724-7000

tina_cuccia@bio-rad.com 

CG Life

Ken Li
312-997-2436  
kli@cglife.com