Table 2

Niche applications of combinations of biomarkers with Food and Drug Administration approval or with potential in the future (unmet needs)

Clinical application



Investigation of pelvic mass

• CA 125 and HE4 (+ ROMA)a

• CA 125 and 7 proteomic markers (+ Danish-Index)b

• FDA-approved (2011)

• FDA-approved (2009)

Improve PSA specificity in screening

• Serum PSA and urine PCA-3 and TMPRSS2-ERG fusionsc

• Pending FDA approval

Separate indolent from aggressive prostate cancer

• PTEN lossc

• TMPRSS2-ERG fusions3

• More research necessarye

Assess risk of malignancy of thyroid nodules with indeterminate results on biopsy

• HBME-1, Galectin-3 and CK19d

• More research necessary

Assess risk of malignancy of CT (± PET) imaging-identified indeterminate lung masses

• CEA, CYFRA 21-1, SCC, CA15.3, Pro-GRP, NSE

• More research necessary

a See [9] for details; b see [10] for details; c see [12,15] for details; d see [16,17] for details. HBME-1 is an antimesothelial cell monoclonal antibody; e PCA-3 was approved by FDA (2012) to help determine the need for repeat prostatic biopsy in men who had a previous negative biopsy. See also [18]. CA: carbohydrate antigen; CT: computed tomography; CK19: cytokeratin 19; CYFRA 21-1: cytokeratin fragment 21-1; FDA: Food and Drug Administration; HBME-1: human bone marrow endothelial 1; HE4: human epididymis protein 4; NSE: neuron-specific enolase; PET: positron emission tomography; pro-GRP: pro-gastrin releasing peptide; PCA3: prostate cancer gene 3; PSA: prostate-specific antigen; PTEN: phosphatase and tensin homolog; ROMA: risk of ovarian malignancy algorithm; TMPRSS2-ERG: transmembrane protease, serine 2 (TMPRSS2) and v-ets erythroblastosis virus E26 oncogene homolog (avian) (ERG)

Diamandis BMC Medicine 2012 10:87   doi:10.1186/1741-7015-10-87

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