Table 1.

US FDA-approved cancer biomarkers^4,6,10

Biomarker	Class	Source	Cancer	Clinical use
Prostate
PSA (total)	P	Serum	Prostate	S, M
PSA (complex)	P	Serum	Prostate	S, M
PSA (free %)	P	Serum	Prostate	Benign hyperplasia vs cancer diagnosis
Breast
HER2	P	Serum	Breast	M
CA15-3	GP	Serum	Breast	M
CA27–29	GP	Serum	Breast	M
OPR	P	Tumor	Breast	Selection of hormonal therapy
HER2/NEU	P	Tumor	Breast	Prognosis and selection of therapy
HER2/NEU	DNA	Tumor	Breast	--ditto--
Bladder
FDP	P	Urine	Bladder	M
BTA	P	Urine	Bladder	M
HMW CEA and mucin	P	Urine	Bladder	M
NMP	P	Urine	Bladder	S, M
Chromosome 3, 7, 9p21, 17	DNA	Urine	Bladder	S, M
Testicular
α-fetoprotein	GP	Serum	Testicular	St
HCG-β	GP	Serum	Testicular	St
Colon
CEA	P	Serum	Colon	M
EGFR	P	Colon	Colon	Selection of therapy
Others
CA19-9	C	Serum	Pancreatic	M
CA125	GP	Serum	Ovarian	M
Thyroglobulin	P	Serum	Thyroid	M
KIT	P	Tumor	GIST	Diagnosis and selection of therapy

HMW: High Molecular Weight; P: Protein; GP: Glycoprotein; C: Carbohydrate; S: Screening; M: Monitoring; St: Staging

BTA- Bladder tumor-associated antigen; CA- Cancer antigen; CEA- Carcinoemryonic antigen; EGFR- Epidermal growth factor receptor; FDP- Fibrin degradation protein; HCG- Human chorionic gonadotropin; HER- Human epidermal growth factor receptor; NMP- Nuclear matrix protein; OPR- Oestrogen and progesterone receptor; PSA-Prostate-specific antigen

Clinical reference limits: HE4 <3.5ug/mL; CEA non-smoker <3ng/mL, smoker <5ng/mL; AFP <6ng/mL; PSA upper limit <2ng/mL (<40years); HER2 <15 ng/mL