The Bloodhound BCR::ABL1 assay simultaneously detects and quantifies all four clinically important isoforms in a single run, offering new capabilities for chronic myeloid leukemia management.

Precipio Inc has announced the publication of a collaborative study with Memorial Sloan-Kettering Cancer Center in the Journal of Clinical Pathology, detailing the performance of its Bloodhound BCR::ABL1 assay for monitoring chronic myeloid leukemia (CML).

The study analyzed 895 peripheral blood and bone marrow samples from patients with suspected, established, or relapsed CML. According to the publication’s authors, the assay’s “ease of use facilitates broad implementation and accessibility across clinical laboratories and resource settings.”

“Our Bloodhound BCR::ABL1 assay is the first and only assay that simultaneously detects and quantifies all four clinically important variants of BCR::ABL1 (isoforms),” says Ilan Danieli, chief executive officer of Precipio, in a release. “Precipio is first to apply the International Scale to create a novel assay quantifying all four variants, setting a new standard for monitoring patients with CML. Now, for the first time, clinicians can comprehensively monitor disease progression.”

Addressing a Gap in Multi-Isoform Testing

Current assays on the market provide quantitative results only for the p210 breakpoint—also referred to as the “Major transcript”—using the established International Standard (IS) scale. Laboratories seeking results for all four isoforms (p190, p210, p230, and p203) have historically needed to run four separate assays.

The study found that 25% of patients have multiple forms of BCR::ABL1 breakpoints, which can go undetected when laboratories lack the capacity or resources to run multiple individual tests. The Bloodhound assay runs all four breakpoints on a single, pre-plated plate run on a reverse transcription polymerase chain reaction (RT-PCR) machine, with all controls provided. Precipio’s custom-developed analysis software delivers fully quantified automated results, including molecular response criteria.

The assay is designed to run in physician office laboratories, regional laboratories, and hospitals.

Sensitivity for Measurable Residual Disease

The Bloodhound BCR::ABL1 assay can detect changes as low as 1 in 100,000 cells (0.001%), according to Precipio. The company says this level of sensitivity makes it a tool for monitoring measurable residual disease, where early trends across isoforms may provide clinicians with months of advance warning that less sensitive or qualitative assays may not detect.

Quantitative results for BCR::ABL1 breakpoints are described in the study as crucial for CML management, enabling clinicians to measure disease burden, monitor treatment response, and detect early relapse. The absence of quantified results for all four isoforms has previously limited clinicians’ ability to monitor patients whose disease recurrence is signaled by isoforms other than p210.

In addition to CML, Precipio notes the BCR::ABL1 test provides diagnostic criteria for patients with acute myeloid leukemia, acute lymphoblastic leukemia, and myeloproliferative neoplasms.

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