| Summary: | A number of biomarkers are used clinically and many protein-based assay methods are available. Improvements in the method to utilize specific antibodies have led to remarkable progress in clinical diagnosis using biomarkers. Proteomics studies to identify better biomarkers have been performed worldwide by using a protein-based comprehensive method. The detection rate of conventional biomarkers can not improve further. Now is a time that a breakthrough is needed. We previously proposed mRNA, which is circulating in the body, as a novel material for biomarkers. mRNA is an unexpectedly useful molecule, not only because it can detect genes with a low expression level in protein, but also because it can detect the expression from non-coding RNA precursor genes or gene products with limited secretion from the cells. Circulating mRNA has been thought to be unstable in blood containing RNase. We confirm that mRNA remains at the same level for 24 hours after blood sampling. Unlike DNA, the RNA molecule can reflect events in the human body which occurred within a day, resulting in an early diagnosis of diseases. We report the possibility to detect and quantify cancer-derived mRNAs circulating in human vessels. We introduce the detection of serum mRNA as a useful biomarker of human malignancies. Abbreviations hTERT: human telomerase reverse transcriptase protein; HCC: hepatocellular carcinoma; hTR: human telomerase RNA template; HCV: hepatitis C virus; HBV: hepatitis B virus; AH: adenomatous hyperplasia; AAH: atypical adenomatous hyperplasia; LC: liver cirrhosis; CH: chronic hepatitis; AFP: α-fetoprotein; DCP; des-γ-carboxy prothrombin; ALT: alanine aminotransferase; Alb: albumin; EGFR: Epidermal growth factor receptor; non-small cell lung cancer; NSCLC: non-small cell lung cancer; small cell lung cancer; SCLC; ADC: adenocarcinoma; SCC: squamous cell carcinoma antigen; SqCC: squamous cell carcinoma; CEA: carcinoembryonic antigen; CYFRA (21–1): cytokeratin 19 fragment; CNA: circulating nucleic acids.
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