Summary: Key to the delivery of preventive healthcare is the clinical adoption of novel assays that enable early disease detection. This review article discusses the clinical utility and validation of miRNA-based molecular diagnostics for early disease detection through large-cohort studies and key considerations for developing multi-analyte clinical assays.
Summary: This paper describes the largest comprehensive, multi-center study to date involving diverse ethnic groups, for the identification of circulating miRNAs for breast cancer screening. The panel detects breast cancer in Caucasian and Asian populations, including pre-malignant lesions (stage 0) and early-stage (stages 1-2) cancers.
Summary: Mammography is extensively used for breast cancer screening but has high false-positive rates. This paper describes the discovery, development, and validation of a serum 6-miRNA panel to discriminate between malignant and benign breast lesions among women with abnormal mammograms.
Summary: Discovery, development, and large-scale prospective clinical validation of GASTROClear – a serum 12-miRNA biomarker panel for early detection of gastric cancer. The panel was validated to detect 87% of all gastric cancer patients, including 87.5% of Stage 1 tumours.
Summary: Discovery, development, and validation of a serum 5-miRNA biomarker panel for early detection of non-small call lung cancer (NSCLC). The panel was validated to detect 81.3% of all NSCLC patients, including 83.0% of Stage 1 tumours.
Summary: Paper describing the development of a high-performance real-time RT-PCR assay that allows specific and rapid quantification of existing and novel miRNAs using a fast thermocycling profile. The assay had a wide dynamic range (more than 7 orders of magnitude) and was capable of detecting miRNAs from as little as 1 picogram of total RNA (or as few as 10 cells).