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Tumor Marker Antigens - IVD Raw Materials


Tumor markers can be defined as some substances produced by the tumor or by the body in response to the tumor. These markers are either produced by tumor cells (tumor-derived) or by the body in response to tumor cells (tumor-associated). Tumor markers can aid cancer detection and/or monitoring. They are typically released into the circulation and thus usually measured in the blood, other body fluids such as urine, effusions, saliva, cerebrospinal fluid (CSF) and nipple discharge can also be used. Current clinical practice in oncology has a growing impetus on early diagnosis, proper prognostication and (of late) screening for malignancy in asymptomatic groups. Tumor markers are assuming a growing role in all aspects of cancer care, starting from screening to follow-up after treatment. Important clinical decisions are increasingly likely to be made on the basis of these results, whether for diagnosis, screening, prediction or treatment monitoring. The advantages of using tumor markers include: 1) screening and early detection of cancer, 2) helping to diagnose cancer, 3) determining response to therapy, 4) prognostic indicator of disease progression and 5) Indicating relapse during follow-up period.


The characteristics of an ideal tumor marker are:

  • It should be specifically produced by either malignant or premalignant tissue, and has a high predisposition of progressing to malignancy;
  • It should be produced at high levels in all patients with specific tumor type;
  • It should be produced in an organ-specific manner;
  • It can be measured in an easily accessible body fluid during early malignancy or during a premalignant phase;
  • The levels of the marker should correlate reliably with the tumor burden, accurately reflecting any tumor progression or regression, along with a short half-life allowing frequent serial measurements;
  • The test used for detection should be cheap for screening application at mass level and should be of such nature as to be acceptable to the target population.

Detection Methods

Tumor Marker AntigensFig 1. Tumor markers (Source: Tietz Textbook of clinical chemistry, 4th Edition, Marshall's Clinical Chemistry)

The detection methods of tumor markers can be classified into 6 major groups: immunological, flow cytometry, cytogenetic analysis, genetic analysis and proteomics. Immunoassay techniques have become the dominant test methods in clinical quantitative detection of tumor markers, due to the highly specific molecular recognition of antibody and epitopes of an antigen, and are mainly: immunohistochemistry (IHC), radio-immuno assay (RIA) and enzyme-linked immunosorbent assay (ELISA). The most commonly used technique today is IHC. Uses of IHC in oncology include categorization of undifferentiated malignant tumors, categorization of leukemias and lymphomas, determination of site of origin of metastatic tumors and detection of molecules of prognostic or therapeutic significance.

Tumor Marker Antigens

In 1965, Gold et al., isolated a glycoprotein molecule from specimens of human colonic cancer and thus discovered the first "tumor antigen," later identified as carcino-embryonic antigen (CEA). Tumor markers include a variety of substances like cell surface antigens, cytoplasmic proteins, enzymes, hormones, oncofetal antigens, receptors, oncogenes and their products. With years of experience in production of IVD raw materials, Creative Diagnostics now can provide our customers expansive range of purified tumor marker antigens for immunoassay development. Welcome to contact us for more details.

  • Alpha-fetoprotein (AFP)

AFP is a major plasma protein produced by the yolk sac and the fetal liver during fetal development. Liver damage and certain cancers, such as hepatocellular carcinoma and nonseminomatous germ cell tumors, can increase AFP concentrations significantly. An extremely high level of AFP in the blood—greater than 500 ng/mL—could be a sign of cancers, including Hodgkin disease, lymphoma, and renal cell carcinoma (kidney cancer). However, not all people with these cancers will have an elevated AFP. And elevated AFP levels also could be a sign of cirrhosis or chronic acute hepatitis.

DAGA-735 Human AFP antigen (>98%) Immunogen, Calibrator
  • Cancer antigen 15-3 (CA 15-3)

Cancer antigen 15-3 (CA 15-3) is a protein that is produced by normal breast cells. It is a serum-based product of the MUC1 gene and is the most widely used serum marker for breast cancer. CA15-3 levels are higher than normal in most women with breast cancer that has spread to other parts of the body (called metastatic breast cancer). Since CA 15-3 can be measured in the blood, it is useful as a tumor marker to follow the course of the cancer.

DAGF-212 Human milk derived MUC1 (CA15-3) antigen Immunogen, Calibrator
  • Cancer antigen 125 (CA 125)

Cancer antigen 125 (CA 125) also known as mucin 16 or MUC16 is a protein which has found application as a tumor marker or biomarker that may be elevated in the blood of some patients with specific types of cancers, or other conditions that are benign. It is found in greater concentration in tumor cells than in other cells of the body. In particular, CA 125 is present in greater concentration in ovarian cancer cells than in other cells.

DAGF-211 CA125 antigen Immunogen, Calibrator
DAGA-751 CA 125 antigen (Control grade,>98%) Control
DAG-H103 Cancer Antigen 125 (CA125, MUC16) ELISA, WB, IA
  • Carbohydrate antigen 19-9 (CA19-9)

Carbohydrate antigen 19-9 (CA19-9), also known as sialyl-Lewis, is a protein that exists on the surface of certain cancer cells. It is known to play a vital role in cell-to-cell recognition processes. It is also a tumor marker used primarily in the management of pancreatic cancer. CA 19-9 test measures the amount of this protein in the blood. It can be used to help differentiate between cancer of the pancreas and other conditions, as well as to monitor treatment response and recurrence.

DAG-T1002 Human CA 19-9 Immunogen, Calibrator
  • Cancer antigen 72-4 (CA 72-4)

The evaluation of CA72-4 is applied for the therapeutic monitoring and postoperative surveillance of patients suffering from gastrointestinal cancers and ovarian cancer, in particular in CA 125 negative patients. Besides, the combination of CA 72-4 with other known tumor markers, such as CEA and CA 19-9 for bowel cancer, or CA 125 for ovarian cancer was able to considerably improve sensitivity without impairing specificity, especially the sensitivity when monitoring for relapse of the disease.

DAGA-770 CA 72-4 antigen (> 80%) Immunogen, Calibrator
  • CA242

The CA-242 antigen is shed from the tumor and the CA-242 can be detected in serum from patients with carcinomas. In the normal healthy subjects and subjects with benign diseases, the CA-242 levels are low, while elevated levels are commonly found in patients with gastro-intestinal cancer. By identifying the colorectal cancer patients at an early stage of the disease, primary diagnosis, often relies on occult blood testing, and on radiological endoscopic examination of the large bowel.

DAGA-800 CA 242 from Metastatic liver (Immunogen grade) Immunogen
DAG-T1009 Human CA 242 Control
  • Carcinoembryonic antigen (CEA)

Carcinoembryonic antigen (CEA) is the most widely used marker for gastrointestinal cancer. CEA may be medically necessary for follow-up of patients with colorectal carcinoma. It would however only be medically necessary at treatment decision-making points. In some clinical situations (e.g. adenocarcinoma of the lung, small cell carcinoma of the lung, and some gastrointestinal carcinomas) when a more specific marker is not expressed by the tumor, CEA may be a medically necessary alternative marker for monitoring.

DAG704 Human Carcinoembryonic Antigen Immunogen, Calibrator
DAGA-773 CEA protein (>95%) ELISA
  • CYFRA21-1

CYFRA 21-1 is a new tumor marker using two different monoclonal antibodies which recognize the divergent epitope on the N- or C-terminal region of domain 2 of cytokeratin 19 fragment, respectively Cytokeratins are epithelial markers whose expression is not lost during malignant transformation. CYFRA 21-1 is a cytokeratin-19 fragment that is soluble in serum and can be used as circulating tumor marker. Although expressed in all body tissues, its major occurrence is in the lung, particularly in lung cancer tissues.

DAGA-793 CYFRA 21-1 antigen Calibrator
  • Hemoglobin

Clinical evidence shows that hemoglobin level is a prognostic factor for overall survival and/or disease-free survival in several hematological malignancies and solid tumors. Hemoglobin level is also a negative predictive factor for response to treatment, in particular to chemotherapy in acute myeloid leukemia and mantle cell lymphoma, and possibly in relapsing ovarian cancer.

DAG109 Human Hemoglobin Calibrator
  • Human epididymis protein 4 (HE4)

Human epididymis protein 4 (HE4) is a protein that is produced by most, but not all, epithelial ovarian cancer cells. This makes the test useful as a tumor marker in specific circumstances. The HE4 test measures the amount of human epididymis protein 4 in the blood. The main established application of HE4 is in post-therapy monitoring of ovarian cancer patients, who had elevated pretreatment levels. In this setting, it complements CA 125 measurement and facilitates follow-up of patients with little or no CA 125 pretreatment elevations.

DAGF-210 Human Epididymis Protein 4 (HE4) Antigen Control
DAG-WT184 Recombinan Epididymis Protein 4 (HE4) from E.coli ELISA
  • Neuron specific enolase (NSE)

Due to this organ-specificity, concentrations of NSE in serum or, more commonly, cerebrospinal fluid (CSF), are often elevated in diseases which result in relative rapid neuronal destruction. Measurement of NSE in serum of CSF can therefore assist in the differential diagnosis of a variety of neuron-destructive and neurodegenerative disorders. NSE might also have utility as a prognostic marker in neuronal injury. There is, for example, increasing evidence that elevated serum NSE levels correlate with a poor outcome in coma, in particular when caused by hypoxic insult.

DAG-T1014 Human NSE Immunogen, Calibrator
DAGA-806 NSE (Control grade,>96%) Control, Calibrator, ELISA
  • Pepsinogen I (PGI)

Pepsinogen consists of a single polypeptide chain of 375 amino acid residues with an average molecular weight of 42 kDa. Pepsinogen I (PGI) is synthesized at gastric chief cells and mucous neck cells, while pepsinogen II (PGII) is also produced by clear mucous cells of antrum, etc. The clinical applications of measuring pepsinogen I and II are a useful aid in the diagnosis of severe atrophic gastritis and stomach cancer. It has been suggested that the measurement of serum pepsinogens serve as a "serological biopsy" for predicting the presence of atrophic gastritis or superficial gastritis.

DAGB106 Human Pepsinogen I (aa16-388) ELISA
DAG-WT113 Pepsinogen I Antigen (PGI Ag) Control, Calibrator
DAGA-784 Recombinant PGI antigen (>90%) ELISA, SDS-PAGE
  • Pepsinogen II (PGII)

Pepsinogen II also known as progastricsin or PGC (pepsinogen C), is an aspartic protease and is a novel marker of type 2. It is involved in proteolysis and peptidolysis. This protein has 2 isoforms produced by alternative splicing. A considerable number of studies, which compared the morphologic changes of gastric mucosa with serum biomarkers, showed a high sensitivity and specificity of serum PGI and PGII as well as its ratio with or without serum gastrin level for the presence of advanced atrophy in the corpus. Therefore, PGI and PGII, are measured as markers of advanced gastritis.

DAGB107 Human Pepsinogen II (aa17-388) ELISA
DAGA-785 Recombinant PGII antigen (>90%) ELISA, SDS-PAGE
  • Prostate-specific antigen (PSA)

Prostate-specific antigen (PSA) is a glycoprotein that is produced by the prostate gland, the lining of the urethra, and the bulbourethral gland. Normally, very little PSA is secreted in the blood. Increases in glandular size and tissue damage caused by benign prostatic hypertrophy, prostatitis, or prostate cancer may increase circulating PSA levels. In patients with previously diagnosed prostate cancer, PSA testing is advocated as an early indicator of tumor recurrence and as an indicator of response to therapy.

DAGA-790 PSA protein (≥96%) ELISA, WB
  • Squamous cell carcinoma antigen (SCCA)

Squamous cell carcinoma antigen (SCCA) can be used as biomarkers for many malignancies in different cancers, for example, cancer cervix, lung cancer, and head and neck cancers. Overexpression of SCCA variants (SCCA1 and SCCA2) has been reported in all surgically resected hepatocellular carcinoma (HCC) specimens but in none of the normal control livers as detected by immunohistochemistry. The discovery of a novel class of tumor markers comprising circulating IgM antibodies forming immune complexes with specific cancer biomarkers has provided opportunities for HCC patient management.

DAGC036 Recombinant Squamous Cell Carcinoma Antigen 1 Protein (a.a.1-390) [GST] SDS-PAGE
DAGC037 Recombinant Squamous Cell Carcinoma Antigen 2 Protein (a.a.144-298) [His] SDS-PAGE, WB, ELISA


  1. Nagpal M, Singh S, Singh P, et al. Tumor markers: A diagnostic tool. National Journal of Maxillofacial Surgery, 2016 Jan-Jun. 7(1): 17–20.
  2. Duffy, MJ. Clinical Uses of Tumor Markers: A Critical Review.Critical Reviews in Clinical Laboratory Sciences, 2001, Sep. 38(3):225-262.
  3. Sharma S. Tumor markers in clinical practice: General principles and guidelines. Indian Journal of Medical and Paediatric Oncology, 2009 Jan-Mar. 30(1): 1–8.
  4. Jie W, Fu Z, Feng Y, et al. Biomedical and clinical applications of immunoassays and immunosensors for tumor markers. TrAC Trends in Analytical Chemistry, 2007 July–Aug. 26(7):679-688.
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