oncology

Established Global Partner

Beckman Coulter is the legal manufacturer of IDL Biotechs tumor markers (TPS®, MonoTotal®, and UBC®) on the ELISA and IRMA-platforms. Beckman Coulter is responsible for the production and global sales of these products.
TPS®

Using TPS® for Cancer Diagnosis

TPS® is a tumor activity marker designed to support prognosis, treatment monitoring, and patient follow-up across a wide range of epithelial cancers, including breast cancer, colorectal cancer, ovarian cancer, and prostate cancer.

What does TPS® measure?

TPS® measures soluble fragments of cytokeratin 18, a structural protein expressed in epithelial cells and frequently over-expressed in cancer. During tumor growth and increased cell turnover, these fragments are released into the bloodstream, where they serve as a marker of tumor cell activity.

This makes TPS® a valuable tool for:

  • Detecting changes in tumor activity
  • Identifying early signs of recurrence
  • Evaluating treatment response in real time

What is the clinical value of TPS® in cancer management?

As a tumor activity marker, TPS® provides clinicians with earlier insights into disease progression compared with conventional tumor mass markers. By reflecting the biological activity of tumor cells, TPS® enables more dynamic monitoring of disease development.

TPS® is particularly useful for:

  • Treatment monitoring
  • Patient follow-up and long-term surveillance
  • Management of epithelial carcinomas, including breast, prostate, and ovarian cancer

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tps tumor activity marker

Clinical Evaluation of TPS® ELISA in Epithelial Cancers

The TPS® ELISA assay is well established for monitoring epithelial cancers and is used to generate reliable information on tumor activity over time.

Clinical studies demonstrate particular relevance in breast and prostate cancer, where the assay supports clinical decision-making during treatment. In addition, the method has shown value in other epithelial malignancies, such as colorectal and ovarian cancer.

By reflecting changes in tumor cell activity, TPS® ELISA complements existing diagnostic tools and contributes to a more informed and individualized patient management approach.

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

MonoTotal®

High sensitivity for Non-Small Cell Lung Cancer (NSCLC)

MonoTotal® is a quantitative immunoassay designed for the assessment of tumor activity in lung cancer, with a particular focus on Non-Small Cell Lung Cancer (NSCLC). It supports prognosis, treatment monitoring, and patient follow-up, providing clinically relevant insights throughout the disease course.

What does MonoTotal® measure?

MonoTotal® measures soluble fragments of cytokeratin 19, 8, and 18, which are released into the bloodstream during tumor growth and increased cell turnover. The concentration of these cytokeratin fragments in serum is directly proportional to tumor cell activity, making MonoTotal® a reliable indicator of disease dynamics.

Elevated levels are associated with epithelial tumor activity, particularly in lung cancer, where changes in biomarker levels can reflect disease progression and treatment response.

What is the clinical value of MonoTotal® in lung cancer management?

Lung cancer is one of the most commonly diagnosed cancers and a leading cause of cancer-related mortality worldwide. Within lung cancer, NSCLC accounts for the majority of cases, highlighting the need for reliable biomarkers to support patient management.

As a tumor activity marker, MonoTotal® provides clinicians with early indications of disease status, enabling:

  • More informed treatment decisions
  • Continuous monitoring of disease progression
  • Improved patient follow-up strategies

 Unlike conventional approaches that primarily assess tumor burden, MonoTotal® reflects real-time tumor cell activity, offering a more dynamic perspective on disease development.

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Clinical Evaluation of MonoTotal® in NSCLC

MonoTotal® has demonstrated a strong correlation with tumor cell activity and disease extent, making it a clinically relevant biomarker for evaluating lung cancer progression.

Published studies show that MonoTotal® is closely associated with clinical response in patients, supporting its role in treatment monitoring. The assay demonstrates high sensitivity in NSCLC, independent of histological subtype, which reinforces its applicability across different patient groups.

With an overall sensitivity of approximately 70–75% at 95% specificity, MonoTotal® provides a robust balance between sensitivity and specificity. This performance, combined with its ability to reflect tumor activity, makes MonoTotal® a reliable tool for assessing disease status and supporting clinical decision-making over time.

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®

Urine-based detection of bladder cancer using UBC®

UBC® is a urine-based immunoassay designed for both primary diagnosis and monitoring of bladder cancer. By providing clinically relevant information from non-invasive urine samples, UBC® supports early detection, treatment monitoring, and patient follow-up.

What does UBC® measure?

UBC® measures soluble fragments of cytokeratin 8 and 18 in urine, proteins that are released during tumor growth and epithelial cell turnover. Elevated levels of these cytokeratin fragments are commonly found in patients with bladder cancer, including those in early stages of the disease.

As a urine-based biomarker, UBC® enables:

  • Non-invasive assessment of bladder cancer
  • Detection of early tumor activity
  • Monitoring of disease progression and recurrence

What is the clinical value of UBC® in bladder cancer management?

Bladder cancer is characterized by a high risk of recurrence, making effective monitoring essential for patient management. UBC® provides clinicians with a reliable tool for assessing tumor activity over time, complementing standard diagnostic procedures.

UBC® is particularly useful for:

  • Primary detection of bladder cancer
  • Monitoring treatment response
  • Long-term patient surveillance, especially in recurrent disease

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Clinical Evaluation of UBC® in Bladder Cancer

The UBC® assay is a valuable tumor marker for epithelial cancers, providing clinically relevant information specifically in bladder cancer management.

Its ability to generate measurable data from urine samples supports clinicians in evaluating disease presence and progression, contributing to more informed and timely clinical decision-making. As part of a broader diagnostic strategy, UBC® enhances the ability to monitor patients consistently over time, particularly in settings where early detection and recurrence monitoring are critical.

 

Cytokeratin

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.

 

Oncology

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.

Bacteriology

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.

Investors

We are listed on NASDAQ First North Growth Market.

We want to be the obvious choice within our segment in the markets where we are established. The market for our products is large and we are a smaller player with significant growth potential so far. IDL Diagnostics is unique for a company of this size.