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Table 1 List of FDA-approved protein tumor markers currently used in clinical practice a

From: Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

Biomarker Clinical use Cancer type Specimen Methodology Submission Year first Device Product
      type approved or class code
       cleared   
Pro2PSA Discriminating cancer from benign disease Prostate Serum Immunoassay PMA 2012 3 OYA
ROMA (HE4+CA-125) Prediction of malignancy Ovarian Serum Immunoassay 510(k) 2011 2 ONX
OVA1 (multiple proteins) Prediction of malignancy Ovarian Serum Immunoassay 510(k) 2009 2 ONX
HE4 Monitoring recurrence or progression of disease Ovarian Serum Immunoassay 510(k) 2008 2 OIU
Fibrin/ fibrinogen degradation product (DR-70) Monitoring progression of disease Colorectal Serum Immunoassay 510(k) 2008 2 NTY
AFP-L3% Risk assessment for development of disease Hepatocellular Serum HPLC, microfluidic capillary electrophoresis 510(k) 2005 2 NSF
Circulating Tumor Cells (EpCAM, CD45, cytokeratins 8, 18+, 19+) Prediction of cancer progression and survival Breast Whole blood Immunomagnetic capture/ immune-fluorescence 510(k) 2005 2 NQI
p63 protein Aid in differential diagnosis Prostate FFPE tissue Immunohistochemistry 510(k) 2005 1 NTR
c-Kit Detection of tumors, aid in selection of patients Gastrointestinal stromal tumors FFPE tissue Immunohistochemistry PMA 2004 3 NKF
CA19-9 Monitoring disease status Pancreatic Serum, plasma Immunoassay 510(k) 2002 2 NIG
Estrogen receptor (ER) Prognosis, response to therapy Breast FFPE tissue Immunohistochemistry 510(k) 1999 2 MYA
Progesterone receptor (PR) Prognosis, response to therapy Breast FFPE tissue Immunohistochemistry 510(k) 1999 2 MXZ
HER-2/neu Assessment for therapy Breast FFPE tissue Immunohistochemistry PMA 1998 3 MVC
CA-125 Monitoring disease progression, response to therapy Ovarian Serum, plasma Immunoassay 510(k) 1997 2 LTK
CA15-3 Monitoring disease response to therapy Breast Serum, plasma Immunoassay 510(k) 1997 2 MOI
CA27.29 Monitoring disease response to therapy Breast Serum Immunoassay 510(k) 1997 2 MOI
Free PSA Discriminating cancer from benign disease Prostate Serum Immunoassay PMA 1997 3 MTG
Thyroglobulin Aid in monitoring Thyroid Serum, plasma Immunoassay 510(k) 1997 2 MSW
Nuclear Mitotic Apparatus protein (NuMA, NMP22) Diagnosis and monitoring of disease (professional and home use) Bladder Urine Lateral flow immunoassay PMA 1996 3 NAH
Alpha-fetoprotein (AFP)b Management of cancer Testicular Serum, plasma, amniotic fluidb Immunoassay PMA 1992 3 LOK
Total PSA Prostate cancer diagnosis and monitoring Prostate Serum Immunoassay PMA 1986 2 LTJ, MTF
Carcino-embryonic antigen Aid in management and prognosis Not specified Serum, plasma Immunoassay 510(k) 1985 2 DHX
Human hemoglobin (fecal occult blood) Detection of fecal occult blood (home use) Colorectal Feces Lateral flow immunoassay 510(k) – CLIA waived 1976 2 KHE
  1. a While hCG is commonly used as a tumor marker, it has not been cleared/approved for this application by the FDA.
  2. b AFP is a Class III analyte because of its non-cancer intended use (aid in prenatal diagnosis of birth defects).