“The study is the result of a collaborative effort between the Instituto Valenciano de Oncología (Dr. Ángel Guerrero-Zotano), the CIBERONC Liquid Biopsy Working Group (Experimental Liquid Biopsy Laboratory/IBIMA Málaga- Dr. Iñaki Comino-Méndez and Dr. Emilio Alba), and the Spanish sequencing company ALTUM, which developed the personalized ctDNA test known as CloneSight.”
Anticipating relapse with long lead times
Using a tumor-informed NGS approach, the authors longitudinally monitored ctDNA in patients who had completed at least five years of endocrine therapy. Notably, the CloneSight test detected ctDNA up to 5.7 years before clinical relapse, a lead time longer than that reported for other MRD assays. Importantly, ctDNA remained undetectable in 93% of patients who did not relapse, supporting its high specificity.
Clinical impact in hormone receptor-positive early breast cancer
Late relapse is a known challenge in luminal breast cancer, and this study highlights the relevance of MRD detection in long-term follow-up strategies. CloneSight was able to detect relapse in patients with difficult-to-monitor presentations, such as isolated brain or bone metastases and local recurrence, suggesting clinical applicability in real-world scenarios.
Towards implementation of affordable MRD testing
Unlike other commercially available tests, CloneSight was designed with scalability and cost-efficiency in mind, using standard volumes of plasma and relying on streamlined workflows. Its development by a Spanish company further underlines the growing national capacity to produce cutting-edge molecular diagnostics tailored to clinical needs.
Read the full study:
https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-025-02016-7