A groundbreaking study presented at the 2024 AACR Annual Meeting showcased an innovative liquid biopsy approach utilizing exosome-based microRNA (miRNA) markers alongside CA19-9 for diagnosing pancreatic ductal adenocarcinoma (PDAC) with remarkable accuracy. Conducted across multinational cohorts, the study yielded robust performances, affirming the potential of this method in early PDAC detection.
Caiming Xu, M.D., Ph.D., along with colleagues from the Beckman Research Institute of The City of Hope in Monrovia, California, conducted a real-time quantitative polymerase chain reaction (qPCR) assay utilizing plasma biospecimens from four prospective cohorts.
In the United States, the validation of miRNA markers exhibited an impressive 93% area under the curve (AUC) with a specificity of 91% and a sensitivity of 87%. Similarly, validations in China and South Korea demonstrated high accuracies, emphasizing the broad applicability of the approach. Notably, the signature proved effective regardless of tumor location, excelling in detecting both head and neck as well as body and tail cancers.
The study also unveiled the capability to detect early-stage PDAC, with miRNA signatures boasting validations exceeding 90% for both stage I/II and III/IV diseases. When combined with CA19-9, diagnostic accuracy soared to 97%, particularly for stage I/II cases, showcasing unprecedented sensitivity and specificity.
Lead researcher Ajay Goel underscored the significance of the findings, highlighting the assay’s optimal balance between sensitivity and specificity, particularly in identifying early-stage PDAC—a crucial determinant for improved patient outcomes. Moreover, the study’s hypothesis, which advocated for the amalgamation of cell-free and exosomal miRNA biomarkers, proved successful, as evidenced by validation across diverse cohorts.
The study’s design, including validation cohorts in multiple countries and a rigorous training phase in Japan, underpinned its robustness and reliability. Utilizing miRNAs was strategic, given their frequent alterations in cancer, stability, detectability in bodily fluids, and presence in blood samples.
Overall, the study’s findings offer a promising paradigm shift in PDAC diagnosis, potentially enhancing early detection rates and subsequent patient survival, particularly in regions where the disease burden is substantial.