Lung cancer

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

Jun 13, 2013

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

MonoTotal® is used for diagnosis, prognosis and therapy monitoring of lung cancer.

MonoTotal® has previously only been available as a radioactive immunoassay (MonoTotal® IRMA). The use of radioactive immunoassays is limited to very few countries. IDL Biotech has now developed an ELISA version of MonoTotal® with equal performance to the radioactive immunoassay; ELISA technology is a global standard method, thus providing many more countries an opportunity to use the product.

Lung cancer is one of the most common cancer forms with a high mortality rate. Early diagnose and good prognosis contributes to improved survival rates. Control after surgery and follow up after cancer treatment are also important factors in the management of patients. MonoTotal® is therefore an important complement to other clinical methods.

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.

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