MonoTotal® | IDL Biotech
IDL Biotech



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 the management of 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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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.

Clinical evaluation

MonoTotal® correlates well with tumor cell activity and the extent of the disease. Studies published during the last years shows 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.

MonoTotal ELISA has been CE marked in accordance with the European IVD Directive

IDL Biotech tumor marker MonoTotal® ELISA has been registered by the Swedish Medical Product Agency for the use in the EU.

Patent approved in Europe

During 2015 the patent ”Method for detection of cytokeratin 8, 18 and/or 19 and/or soluble fragments thereof” was approved in Sweden. In September 2017 the patent was approved in China. The patent has now also been approved in Europe and is valid until 2034.

What is cytokeratins?

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.

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