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

Füzéry, Anna K; Levin, Joshua; Chan, Maria M; Chan, Daniel W

doi:10.1186/1559-0275-10-13

Clinical Proteomics

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 fluid^b	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

^a While hCG is commonly used as a tumor marker, it has not been cleared/approved for this application by the FDA.
^b AFP is a Class III analyte because of its non-cancer intended use (aid in prenatal diagnosis of birth defects).

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ISSN: 1559-0275

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