The novel method showed satisfactory assay performance in addition to drastically reduced analysis times and improved ease of use as compared to other methods. Clinical utility of HDL 2b was demonstrated supporting the findings of previous studies.

Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide. Effective treatment of HCC patients is hampered by the lack of sensitive and specifi c diagnostic markers of HCC. Alpha-fetoprotein (AFP), the currently used HCC marker, misses 30%-50% of HCC patients, who therefore remain undiagnosed and untreated. In order to identify novel diagnostic markers that can be used individually or in combination with AFP, we used an antibody array platform to detect the levels of candidate proteins in the plasma of HCC patients (n = 48) and patients with chronic hepatitis B or C viral infections (n = 19) (both of which are the major risk factors of HCC). We identifi ed 7 proteins that signifi cantly differentiate HCC patients from hepatitis patients (p Ͻ 0.05) (AFP, CTNNB, CSF1, SELL, IGFBP6, IL6R, and VCAM1). Importantly, we also identifi ed 8 proteins that signifi cantly differentiate HCC patients with 'normal' levels of AFP (Ͻ20 ng/ml) from hepatitis patients (p Ͻ 0.05) (IL1RN, IFNG, CDKN1A, RETN, CXCL14, CTNNB, FGF2, and SELL). These markers are potentially important complementary markers to AFP. Using an independent immunoassay method in an independent group of 23 HCC patients and 22 hepatitis patients, we validated that plasma levels of CTNNB were signifi cantly higher in the HCC group (p = 0.020). In conclusion, we used an antibody array platform to identify potential circulating diagnostic markers of HCC, some of which may be valuable when used in combination with AFP. The clinical utility of these newly identifi ed HCC diagnostic markers needs to be systematically evaluated.

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