This is the only assay available on the market that delivers full quantification of all four clinically relevant BCR::ABL1 isoforms
NEW HAVEN, Conn., March 10, 2026 (GLOBE NEWSWIRE) — Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) has announced the publication1 in the Journal of Clinical Pathology of a study conducted in collaboration with the Memorial Sloan-Kettering Cancer Center, demonstrating Precipio’s new Bloodhound BCR::ABL1 assay for Chronic Myeloid Leukemia (CML).
According to the publication’s authors: “Its ease of use facilitates broad implementation and accessibility across clinical laboratories and resource settings.”
Ilan Danieli, CEO of Precipio, expanded on these findings. “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). 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.”
The study analyzed 895 peripheral blood and bone marrow samples from patients with suspected, established or relapsed CML, and underscores the key advantage of a single assay that delivers multiple, medically relevant data points simultaneously. The assay can be run in physician office laboratories, regional laboratories and hospitals.
Key findings in the study highlight significant advantages of the assay
1. Multiple data points lead to better decision making
The study demonstrates that 25% of patients have multiple forms of BCR::ABL1 breakpoints that are missed because looking for all four requires laboratories to run four different assays (isoforms p190, p210, p230 and p203). No other test delivers all results from the same platform at the same time.
2. Full Quantification establishes a new standard
Quantitative results for BCR::ABL breakpoints are crucial for the management of CML, providing clinicians a precise, standardized measurement of the disease burden, thereby enabling them to monitor the impact of treatment and detect early relapse.
Current assays on the market provide quantitative results only for one breakpoint, p210 (also called “Major transcript”), using an established International Standard (IS) scale. The absence of quantified results for all four breakpoints hinders clinicians’ ability to adequately monitor patients if other isoforms other than p210 indicate recurrence.
3. High Sensitivity for MRD
Precipio’s Bloodhound BCR::ABL assay can detect changes as low as 1 in 100,000 cells (0.001%), thereby making it a powerful tool for monitoring measurable residual disease (MRD). At these low levels, early trends in these isoforms can provide months of advanced warning time that other, less sensitive or qualitative assays may not detect.
Assay introduces new testing capabilities for laboratories
The diagnosis and therapeutic decision-making in CML depend on the detection and quantification of BCR::ABL1. Until now, no clinical assay existed that could simultaneously test multiple BCR::ABL1 isoforms and provide quantified results, therefore requiring laboratories to run separate tests for each isoform.
To address this challenge, Precipio developed the BloodHound assay, enabling laboratories to provide proper, comprehensive testing for CML patients. The assay runs all 4 breakpoints on a single, pre-plated plate run (with all controls provided) on a RT-PCR machine. Precipio’s custom-developed analysis software provides fully quantified automated results including molecular response criteria. The BCR::ABL1 test provides important diagnostic criteria for patients with AML, ALL and MPN.
The new Precipio test simplifies workflow into one assay, is standardizable across laboratories, is quantitative and, importantly, provides target genetic markers to enable monitoring disease for years over the treatment course.
About Precipio
Precipio is a healthcare biotechnology company focused on cancer diagnostics. Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services. Our products and services deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. Precipio develops innovative technologies in our laboratory where we design, test, validate, and use these products clinically, improving diagnostic outcomes. Precipio then commercializes these technologies as proprietary products that serve the global laboratory community and further scales Precipio’s reach to eradicate misdiagnosis.
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1 PMID: 41506866 DOI: 10.1136/jcp-2025-210447
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