Conference Abstracts - Summit on Cancer Health Disparities (SCHD25)
Vol. 5, Issue Supplement 1, 2025 · S1-1
Spot on CML: Expanding Access to Chronic Myeloid Leukemia Diagnostics in Low- and Middle-Income Countries
Jennifer Rynning, MPH,Inés García González, BA,Alicia Annamalay, PhD,Cecilia Yeung, MD,Olga Sala-Torra, MD,Lan Beppu, BSc,Lauryn Stathem, MB,Pat Garcia-Gonzalez, MA,Jerald Radich, MD
Submission received: 2025-02-14 / Accepted: 2025-03-12 / Published: 2025-04-24
Abstract
Background
Patients with cancer in low- and middle-income countries (LMICs) face barriers to molecular diagnostics due to high costs, logistical challenges, and limited laboratory infrastructure. Diagnosing and monitoring chronic myeloid leukemia (CML) requires ultrasensitive molecular testing for BCR::ABL1, but access is limited in LMICs. Spot on CML, a collaboration between the Max Foundation (Max) and the Radich Lab at the Fred Hutchinson Cancer Center, addresses this by enabling dried blood spot (DBS) testing with nested polymerase chain reaction (PCR). DBS cards are shipped via conventional mail to the Radich Lab at no cost to the patient.
Methods
Max partners with 500+ physicians in 650+ institutions, providing access to treatment, diagnostics, and support to over 50,000 CML patients across 70+ LMICs. Spot on CML provides BCR-ABL1 PCR testing via Xpert® BCR-ABL1 Ultra (Cepheid) and single gene mutation analysis via next generation sequencing (NGS) on the Genexus System, targeting ABL1 gene variants. Physicians request support for diagnostic testing, and Max supplies filter paper cards and shipping materials. Blood samples are collected, spotted onto filter paper cards (50ul per spot), dried, and mailed to the Radich Lab. Results are then shared with physicians to facilitate timely treatment decisions.
Results
Between 2019 and 2024, Spot on CML provided 959 diagnostic results to patients in 22 LMICs, across Africa (58%), Latin America (22%), South Asia (18%), Asia Pacific (15%), and Eastern Europe (8%). Among those reporting demographics, 44% were female, and the average age of diagnosis was 58 years. The average turnaround time was 15 days for BCR-ABL1 PCR testing and 47 days for mutation analysis.
Conclusion
Spot on CML showcases how partnerships and innovative diagnostics can overcome access barriers for patients in LMICs. The program has enabled hundreds of patients to receive diagnoses and access medication, with scaling efforts set to further expand diagnostic reach.