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



Lung cancer

June 2013

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.

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.

IDL Biotech includes additional clinics in its ongoing multicenter study for UBC® Rapid in Sweden.

IDL Biotech currently has a number of ongoing clinical studies both internationally and in Sweden, with the aim of demonstrating the clinical benefit of UBC® Rapid in bladder cancer and having the test included as a complement in the follow-up of patients with bladder cancer who are classified as high risk.

IDL Biotech signs distributor agreements in Rwanda, South Sudan and Somalia

IDL Biotech continues to expand in Africa. Today, IDL Biotech has signed a distributor agreement with Roi Scientific Ltd covering Rwanda, South Sudan and Somalia. The agreement covers the sale of TUBEX® TF.

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