ORIGINAL ARTICLE

Cell Research (2008): 997-1006
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Characterization of microRNAs in serum: a novel class of biomarkers for diagnosis of cancer and other diseases

Xi Chen^1,*, Yi Ba^2,*, Lijia Ma^3,4,*, Xing Cai¹, Yuan Yin¹, Kehui Wang¹, Jigang Guo¹, Yujing Zhang¹, Jiangning Chen¹, Xing Guo¹, Qibin Li^3,4, Xiaoying Li⁵, Wenjing Wang⁶, Yan Zhang¹, Jin Wang¹, Xueyuan Jiang¹, Yang Xiang¹, Chen Xu¹, Pingping Zheng³, Juanbin Zhang³, Ruiqiang Li³, Hongjie Zhang¹, Xiaobin Shang², Ting Gong², Guang Ning⁵, Jun Wang^3,4, Ke Zen¹, Junfeng Zhang¹ and Chen-Yu Zhang¹

Correspondence: Chen-Yu Zhang Tel/fax: +86-25-83686234 E-mail: cyzhang@nju.edu.cn; Junfeng Zhang, Tel/fax: +86-25-83686234 E-mail: jfzhang@nju.edu.cn; Ke Zen, Tel/fax: +86-25-83686234 E-mail: kzen@nju.edu.cn; Jun Wang, Tel/fax: +86-25-83686234 E-mail: wangj@genomics.org.cn *These three authors contributed equally to this work.

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Dysregulated expression of microRNAs (miRNAs) in various tissues has been associated with a variety of diseases, including cancers. Here we demonstrate that miRNAs are present in the serum and plasma of humans and other animals such as mice, rats, bovine fetuses, calves, and horses. The levels of miRNAs in serum are stable, reproducible, and consistent among individuals of the same species. Employing Solexa, we sequenced all serum miRNAs of healthy Chinese subjects and found over 100 and 91 serum miRNAs in male and female subjects, respectively. We also identified specific expression patterns of serum miRNAs for lung cancer, colorectal cancer, and diabetes, providing evidence that serum miRNAs contain fingerprints for various diseases. Two non-small cell lung cancer-specific serum miRNAs obtained by Solexa were further validated in an independent trial of 75 healthy donors and 152 cancer patients, using quantitative reverse transcription polymerase chain reaction assays. Through these analyses, we conclude that serum miRNAs can serve as potential biomarkers for the detection of various cancers and other diseases.

Cell Research (2008) 18:997–1006. doi: 10.1038/cr.2008.282; published online 2 September 2008

Keywords: serum-microRNA, expression profile, fingerprint, blood-based biomarker, Solexa, cancers, diabetes