Advancements in AffiCELL-Based BCR-ABL Detection: Enhancing Precision in CML Treatment Monitoring

Chronic myeloid leukemia (CML) is a hematopoietic stem cell disorder characterized by the presence of the BCR-ABL fusion gene, which drives leukemic cell proliferation. The development of tyrosine kinase inhibitors (TKIs) has revolutionized CML treatment, leading to improved patient outcomes. However, accurate and sensitive detection of BCR-ABL transcripts is essential for monitoring disease progression and guiding treatment decisions. AffiCELL technology offers a robust platform for the detection of BCR-ABL transcripts, providing clinicians with crucial information for optimizing patient care. This article reviews the technical aspects of AffiCELL-based BCR-ABL detection and its clinical implications in CML management.

Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the presence of the Philadelphia chromosome (Ph), resulting from a reciprocal translocation between chromosomes 9 and 22 [t(9;22)(q34;q11)], leading to the formation of the BCR-ABL fusion gene. The constitutively active BCR-ABL tyrosine kinase drives leukemic cell proliferation and survival, underscoring its role as a therapeutic target in CML. The advent of tyrosine kinase inhibitors (TKIs), such as imatinib, dasatinib, and nilotinib, has dramatically improved the prognosis for CML patients, transforming the disease from a fatal condition to a manageable chronic illness.

However, achieving optimal outcomes with TKI therapy requires careful monitoring of BCR-ABL transcript levels, as early detection of molecular relapse can guide timely treatment adjustments to prevent disease progression and resistance development. Traditional methods for BCR-ABL monitoring, such as quantitative reverse transcription-polymerase chain reaction (qRT-PCR), have limitations in terms of sensitivity, specificity, and turnaround time. AffiCELL technology offers a promising alternative for sensitive and accurate BCR-ABL detection, providing clinicians with valuable information for personalized CML management.

AffiCELL Technology

AffiCELL is a novel molecular diagnostic platform based on affinity capture and isothermal amplification principles. The technology utilizes specific probes designed to target BCR-ABL transcripts with high affinity and selectivity. Upon hybridization of the target RNA molecules to the capture probes, the AffiCELL system initiates an isothermal amplification reaction, leading to the generation of detectable signals proportional to the target RNA concentration. This streamlined process enables rapid and sensitive detection of BCR-ABL transcripts directly from patient samples, without the need for complex instrumentation or extensive sample preparation.

Key Features and Advantages

AffiCELL-based BCR-ABL detection offers several key features and advantages that make it an attractive tool for routine monitoring of CML patients


AffiCELL technology exhibits high sensitivity, allowing for the detection of low levels of BCR-ABL transcripts, even in samples with minimal residual disease (MRD). This level of sensitivity is crucial for identifying molecular relapse early, enabling prompt intervention to prevent disease progression.


AffiCELL probes are designed to specifically target BCR-ABL transcripts, minimizing the risk of false-positive results due to nonspecific amplification or cross-reactivity with unrelated sequences. This high level of specificity ensures accurate and reliable detection of BCR-ABL fusion transcripts, enhancing confidence in treatment decision-making.

Rapid Turnaround Time

AffiCELL assays can be performed rapidly, with results available within hours of sample collection. This rapid turnaround time allows for timely assessment of treatment response and facilitates prompt adjustments to therapy, optimizing patient outcomes.

User-Friendly Workflow

The AffiCELL workflow is streamlined and user-friendly, requiring minimal hands-on time and technical expertise. The simplicity of the assay procedure makes it suitable for implementation in both centralized laboratories and point-of-care settings, enhancing accessibility to BCR-ABL monitoring for CML patients worldwide.

Clinical Implications

The integration of AffiCELL-based BCR-ABL detection into routine clinical practice holds significant clinical implications for CML management

Treatment Optimization

Accurate and timely monitoring of BCR-ABL transcript levels with AffiCELL technology enables clinicians to optimize TKI therapy based on individual patient responses. By identifying molecular relapse early, clinicians can adjust treatment regimens promptly, thereby minimizing the risk of disease progression and maximizing treatment efficacy.

Personalized Medicine

AffiCELL-based BCR-ABL monitoring facilitates a personalized approach to CML treatment, allowing clinicians to tailor therapy to the specific needs of each patient. By monitoring BCR-ABL kinetics over time, clinicians can identify patients at risk of treatment failure or progression and intervene proactively to improve outcomes.

Long-Term Disease Management

Continuous monitoring of BCR-ABL transcript levels using AffiCELL technology provides valuable insights into the long-term management of CML. By tracking changes in BCR-ABL levels over time, clinicians can assess treatment response, detect emerging resistance mutations, and guide subsequent treatment decisions, ultimately improving patient survival and quality of life.

In conclusion AffiCELL-based BCR-ABL detection represents a valuable tool for the management of CML, offering sensitive, specific, and rapid assessment of treatment response. By enabling early detection of molecular relapse and facilitating personalized treatment strategies, AffiCELL technology has the potential to improve outcomes for CML patients worldwide. Further research and clinical validation are warranted to fully establish the clinical utility of AffiCELL-based BCR-ABL monitoring and its impact on long-term disease management.

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