Cancer Biomarkers in Clinical Use

Cancer biomarkers are present in tumor tissues or serum and encompass a wide variety of molecules, including DNA, mRNA, transcription factors, cell surface receptors, and secreted proteins. Cancer biomarkers can be used for prognosis: to predict the natural course of a tumor, indicating whether the outcome for the patient is likely to be good or poor (prognosis). They can also help doctors to decide which patients are likely to respond to a given drug (prediction) and at what dose it might be most effective (pharmacodynamics).

An ideal cancer biomarker should be measured easily, reliably and cost-effectively using an assay with high analytical sensitivity and specificity. In addition, an ideal cancer biomarker should be present in detectable quantities at early or preclinical stages and the quantitative levels of the caner biomarker should reflect tumor burden. Recent technological advances, especially in the fields of genomics and proteomics, have made it easier to identify many cancer biomarkers at once in high-throughput screens. The validation of cancer biomarkers - that is, determination of clinical relevance and applicability - is also quite challenging, and many questions have been raised regarding how new tests will be developed, evaluated, and integrated into clinical use.

FDA approval dates for tests were obtained from the FDA Center for Devices and Radiological Health database. Proteins designated here as clinical cancer biomarkers are those offered commercially by ARUP or by Mayo Medical Laboratories, or else offered for internal use by either NIH or the Fred Hutchinson Cancer Research Center. The following table is about cancer biomarkers that are currently in clinical use.

Cancer biomarkers in clinical use
Cancer Biomarker Names Alternative Names Cancer type
Clinical use based on ASCO and/or NACB recommendations
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HER2 ErbB2, NEU, CD340 Breast cancer
Select patients for trastuzumab therapy
PSA Prostate-specific antigen, Kallikrein 3, KLK3 Prostate cancer
Screening (with DRE)
Diagnosis (with DRE)
Alfa-fetoprotein AFP, α-fetoprotein Germ-cell cancer
Hepatoma cancer
Diagnosis
Differential diagnosis of NSGCT
Staging
Detecting recurrence
Monitoring therapy
Human
chorionic gonadotropin-β
β-hCG Testicular cancer
Diagnosis
Staging
Detecting recurrence
Monitoring therapy
Calcitonin Thyrocalcitonin Medullary thyroid cancer
Diagnosis
Monitoring therapy
 
CA125 mucin 16, MUC16 Ovarian cancer
Prognosis
Detecting recurrence
Monitoring therapy
 
CA 15-3 Carcinoma Antigen 15-3 Breast cancer
Monitoring therapy
 
CA 19-9 cancer antigen 19-9, sialylated Lewis (a) antigen Pancreatic cancer
Monitoring therapy
 
Carcinoembryonic antigen CEA Colon cancer
Monitoring therapy
Prognosis
Detecting recurrence
Screening for hepatic metastases
 
ER Estrogen receptor Breast cancer
Select patients for endocrine therapy
 
PgR PR, NR3C3 Breast cancer
Select patients for endocrine therapy
 
Lactate dehydrogenase LDH, LD Germ cell cancer
Diagnosis
Prognosis
Detecting recurrence
Monitoring therapy
 
Thyroglobulin Tg Thyroid cancer
Monitoring
 
Abbreviations DRE, digital rectal examination; ER, estrogen receptor; NACB, National Academy of Clinical Biochemistry; NSGCT, nonseminomatous germ cell tumor; PgR, progesterone receptor.
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