Rainsure Scientific BCR-ABL IS Digital PCR Assays: Precision Monitoring for Chronic Myeloid Leukemia

Rainsure Scientific BCR-ABL IS Digital PCR Assay: Precision in CML Monitoring

Chronic Myeloid Leukemia (CML) management has entered a new era, driven by advanced molecular diagnostics. At the forefront of this evolution is the BCR-ABL International Scale (IS) Digital PCR Assay from Rainsure Scientific — a clinically optimized solution for ultra-sensitive, reproducible, and standardized quantification of BCR-ABL1 transcripts.

Using digital PCR (dPCR) technology, this assay enables precise measurement of molecular response in CML patients, even at minimal residual disease (MRD) levels, aligning with international guidelines and clinical best practices.

What is BCR-ABL and Why Use the International Scale?

The BCR-ABL fusion gene, a hallmark of CML, results from the Philadelphia chromosome translocation (t(9;22)). Quantifying BCR-ABL1 transcript levels is crucial for:

· Diagnosing CML

· Monitoring treatment response to tyrosine kinase inhibitors (TKIs)

· Assessing molecular remission and relapse risk

The International Scale (IS) was developed to harmonize results across labs and platforms. Rainsure’s assay is calibrated to the IS, enabling standardized results that clinicians can compare globally.

Advantages of Rainsure’s Digital PCR-Based BCR-ABL IS Assay

Rainsure Scientific combines cutting-edge digital PCR technology with robust assay design to offer unmatched performance in BCR-ABL monitoring:

Ultra-High Sensitivity

Detects BCR-ABL1 transcript levels down to MR^4.5 and beyond, identifying residual disease with extreme precision.

International Scale Standardization

IS-calibrated assay ensures reliable, reportable molecular monitoring per ELN and NCCN guidelines.

High Accuracy and Reproducibility

Digital PCR offers absolute quantification without the need for standard curves, reducing inter-lab variability.

Easy Workflow Integration

Compatible with standard digital PCR platforms, the assay kit includes ready-to-use reagents, simplified protocols, and internal control gene (ABL1 or GUSB) options.

Clinical Applications

The Rainsure BCR-ABL IS digital PCR assay supports physicians and laboratories with essential capabilities for:

· Baseline quantification at diagnosis

· Routine molecular monitoring during TKI therapy

· Deep molecular response assessment (MR^4, MR^4.5, MR^5)

· Decision-making in treatment-free remission (TFR) trials

· Detecting molecular relapse after therapy discontinuation

Accurate BCR-ABL tracking is critical in guiding therapy decisions, especially in patients aiming for treatment-free remission, where monitoring deep and durable molecular response is essential.

Why Choose Rainsure Scientific?

Rainsure Scientific is a trusted provider of high-precision molecular assays for clinical and research laboratories worldwide. Our digital PCR assays stand out for their:

· Clinical-grade performance

· Fast turnaround time

· Stringent quality control

· Dedicated technical support

Rainsure’s BCR-ABL IS assay is not only diagnostically validated but also cost-effective, making high-quality monitoring accessible to more institutions and patients.

Final Thoughts

When it comes to CML monitoring, precision is non-negotiable. Rainsure Scientific’s BCR-ABL IS digital PCR assay offers a gold-standard solution for highly accurate, standardized, and sensitive quantification of BCR-ABL1 transcripts. Backed by international calibration and powered by digital PCR, it is the ideal tool for clinicians and laboratories aiming for excellence in leukemia care.