# Digital PCR quantification of BCR-ABL for CML diagnosis and monitoring in a LMICs setting

> **NIH NIH UH3** · UNIVERSITY OF WASHINGTON · 2020 · $753,619

## Abstract

Project Abstract
 We propose to develop a low resource setting (LRS) digital PCR (dPCR) instrument to detect BCR-ABL
transcripts from small blood samples to identify chronic myeloid leukemia (CML) patients who are eligible for
tyrosine kinase inhibitor (TKI) therapy in low- and middle- income countries (LMICs). Despite the success of
the targeted TKI Glivec (Gleevec, imatinib) in treating CML in developed countries, the majority of the world's
CML patients reside in LMICs with limited access to diagnostic testing and TKI treatment. The Glivec
International Patient Assistance Program (GIPAP) is one of the most comprehensive and far-reaching global
cancer access programs designed by the Novartis (the manufacturer of Glivec) in partnership with the Max
Foundation (TMF) to facilitate access to and distribution of Glivec (imatinib) directly to eligible patients through
their providers. One of the major challenges of the implementation of GIPAP program is the lack of diagnostic
capabilities in many GIPAP countries which are essential for selecting patients for the TKI therapy, since only
patients who are properly diagnosed with Philadelphia chromosome positive CML (Ph+ CML) are eligible to
participate in the GIPAP program. We hypothesize that a LRS dPCR instrument to detect the BCR-ABL
transcript in a highly sensitive manner will enable more health care institutes in LMICs capabilities to diagnose
Ph+ CML and participate in the GIPAP program, as well as monitor patients who are being treated with TKI.
We will develop the LRS dPCR instrument by adapting technologies recently developed in our laboratories
including a novel digital nucleic acid amplification platform based on a self-digitization (SD) microfluidic chip,
which partitions an aqueous sample into tens of thousands of nanoliter volumes suitable for PCR, instruments
for efficient sample loading using centrifugal force and signal detection using optical disc (OD, e.g. CD, DVD,
Blu-Ray)-styled readers which are highly compatible to the LMICs setting. We propose to leverage these
innovative technologies to create a LRS dPCR instrument matching or exceeding the sensitivity and specificity
of the current state of the art RT-PCR BCR-ABL fusion transcript assay, with minimal sample preparation and
without the need of run to run standards. Such an instrument will have significant impact on improving CML
patients' survival in LMICs.

## Key facts

- **NIH application ID:** 10019478
- **Project number:** 5UH3CA211139-04
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Daniel T Chiu
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $753,619
- **Award type:** 5
- **Project period:** 2017-05-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10019478

## Citation

> US National Institutes of Health, RePORTER application 10019478, Digital PCR quantification of BCR-ABL for CML diagnosis and monitoring in a LMICs setting (5UH3CA211139-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10019478. Licensed CC0.

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