Established Global Partner

Beckman Coulter is the legal manufacturer of IDL Biotechs tumor markers (TPS®, MonoTotal®, UBC®, and TPAcyk™) and has taken over the products’ production and global sales.

Combating Cancer with TPS®

TPS® is a tumor activity marker assay used to support prognosis, treatment monitoring, and patient follow-up for various epithelial cancers, including breast, colorectal, ovarian, and prostate cancer.

TPS® measures soluble fragments of cytokeratin 18, which is over-expressed in epithelial cells and particularly in many types of cancer. This information is crucial for early detection of cancer recurrence and the quick assessment of treatment efficacy.

The tumor marker TPS® is a reliable indicator of tumor cell activity particularly useful in patient management for different carcinomas. Compared with conventional tumor mass markers, the activity marker TPS® provides the clinician with earlier signals about the course of the disease. TPS® is particularly useful in treatment monitoring and surveillance of patients with epithelial cell carcinomas e.g. breast, prostate, and ovarian cancer.

The TPS® ELISA only for China is manufactured and distributed by IDL Biotech.


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tps tumor activity marker

Clinical evaluation

TPS® ELISA assay is a valuable tumor marker for epithelial cancer, generating clinical information in breast and prostate cancer but also valuable in other forms of epithelial cell tumors such as colorectal and ovarian cancer.

References for TPS®

TPS® general
1. Barak V., et al. Clinical utility of cytokeratins as tumor markers. Clin Biochem 2004; 37:529-540

2. Rydlander L., et al. Molecular characterization of a tissue-polypeptide specific antigen epitope and its relationship to human cytokeratin 18. Eur J Biochem. 1996; 241: 309-314

TPS® in breast
3.  Ahn S.K., et al. Preoperative serum tissue polypeptide-specific antigen is a valuable prognostic marker in breast cancer. Int J Cancer. 2013; 132:875-881 

TPS® in prostate
4. Kil P.J., et al. Tissue polypeptide specific (TPS) determination before and during intermittant maximal androgen blockade in patients with prostatic carcinoma. Euro Urol. 2003; 43:31-38

TPS® in ovarian
5. Van Dalen A., et al. Significance of serum CA125 and TPS antigen levels for detemination of overall survival after three chemotherapy courses in ovarian cancer patients during long-term follow-up. Eur J Gynaec Oncol. 2009; 30:609-615


For high sensitivity in NSCLC

MonoTotal® is a quantitative immunoassay that specifically measures defined epitopes on cytokeratin 19, 8, and 18. The test result is directly proportional to the concentration of soluble cytokeratin fragments in serum. An elevated level of soluble cytokeratin fragments in patient samples is an indication of epithelial tumor cell activity.

Lung cancer is the most frequently diagnosed cancer and the leading cause of cancer mortality worldwide. Patients may suffer from one of two cancer types: Non-Small Cell Lung Cancer (NSCLC), or the less common, Small-Cell Lung Cancer (SCLC).

Cancer biomarkers are effective for prognostic evaluation and monitoring of disease. MonoTotal® is a sensitive and efficient tool for managing patients with Non-Small Cell Lung Cancer (NSCLC).

With MonoTotal®, physicians receive an early indication of disease status, measured in terms of tumor cell activity rather than more conventional tumor burden measurements. MonoTotal® provides the physician with a reliable monitoring aid for disease progression and treatment in lung cancer patients.

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Clinical evaluation

MonoTotal® correlates well with tumor cell activity and the extent of the disease. Studies published during the last years show that MonoTotal®has a strong association with clinical response in patients. MonoTotal®demonstrates high sensitivity in patients with NSCLC, independent of histotype. The overall sensitivity is about 70-75%, at 95% specificity, and correlates well with tumor cell activity and the extent of the disease.

References for MonoTotal®

1. Barak, V. et al. Clinical utility of cytokeratin as a tumor marker. Clin Biochem. 2004;37:529-540.

2. Eriksson, P. et al. Role of circulating cytokeratin fragments and angiogenic factors in NSCLC patients stage IIIa-IIIb receiving curatively intended treatment. Neoplasma. 2006;53:285-290.

3. Topolcan, O. et al. The importance of MonoTotal® for primary diagnosis of patients with non-small cell lung cancer (NSCLC). Anticancer Res. 2008;28:4038-4039.

4. Kim, DW. et al. Evaluation of usefulness for MonoTotal™ in non-small cell lung cancer. J Nucl Med Tech. 2009;13:171-174.

5. Wojcik, E. et al. Evaluation of the diagnostic utility of MonoTotal® in lung cancer patients. J Lab Diagn. 2009; 45:75-80.

6. Topolcan, O. et al. (Abstract). MonoTotal® – prognosis and therapy control in patients with non small cell lung cancer (NSCLC). XIIth International Symposium on Biology and Clinical Usefulness of Tumor Markers, February 4-7, 2009, Barcelona, Spain.

7. Prazakova, M. et al. The role of MonoTotal® in the primary diagnosis, prognosis and follow-up of patients with non-small cell lung cancer (NSCLC) Anticancer Res. 2011;31:3107-3112.


UBC® ELISA for Bladder Cancer detection

UBC® is an immunoassay for both primary diagnosis and monitoring of bladder cancer. The test specifically measures soluble fragments of cytokeratin 8 and 18 in urine samples. Elevated amounts of cytokeratin protein fragments are present in the urine of many individuals with bladder cancer, even at the early stages of the disease.


UBC® is available in ELISA and Rapid format.

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TPAcyk™ for indication of tumor cell activity

TPAcyk™ is an indicator of tumor cell activity and is useful in the management of patients with carcinomas of epithelial origin. This cytokeratin based tumor marker gives early and distinct measurements of ongoing tumor cell activity and serves as an efficient tool for the detection of changes in the disease state. TPAcyk™ is a general indicator of tumor cell activity, particularly for monitoring of treatment and follow-up of different epithelial carcinoma. TPAcyk™ measures key epitopes of Tissue Polypeptide Antigen (TPA) fragments. The antibodies used in the test are specific for cytokeratin 8 and 18 in serum. Being specific for a certain type of cells, TPAcyk™ has proven useful for monitoring of epithelial cell cancer diseases. By establishing TPAcyk™ in routine care, this marker can be beneficially used for monitoring more than one disease.]

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Most eukaryotic cells have cytoplasmic cytoskeletal structures known as intermediate filaments. The cytoskeletal network is responsible for the mechanical integrity of the cell, and it is critical during cellular processes like cell division, motility and cell to cell contacts. At present more than 20 different cytokeratins have been identified, of which cytokeratin 8, 18, and 19 are the most abundant in simple epithelial cells. The cytokeratins are epithelial cell-specific and the cytokeratin pattern is usually preserved during the transformation of normal cells into malignant cells.

Cytokeratins in cancer

Cancer affects everyone – the young and old, the rich and poor, men, women, and children – and represents a tremendous burden on patients, families, and societies. Cancer is one of the leading causes of death in the world.
Normal cells are constantly dividing, but in cancer, abnormal cell growth occurs. This causes the protein cytokeratin to leak out which can be measured with efficient diagnostic tools. Thanks to modern technology, IDL Biotech can quickly diagnose several kinds of cancer in a non-invasive and pain free manner.



Diagnostics for oncology

Cancer is one of the leading causes of death worldwide, despite advancing knowledge. To improve cancer patient management, there is a clear need for efficient diagnostics tools to capture this critical clinical data.


An effective typhoid test

Typhoid fever is water and food-borne infectious disease caused by the bacterium, Salmonella enterica. IDL Biotechs product TUBEX® TF, is a rapid and sensitive in vitro diagnostic test for the detection of acute typhoid fever.


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