MonoTotal ELISA has been CE marked in accordance with the European IVD Directive | IDL Biotech
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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 förbereder kliniska studier i USA för sitt snabbtest för blåscancer, UBC® Rapid

Under 2019 lämnade IDL Biotech in underlag, en så kallad ”pre-submission request”, till amerikanska FDA (Food and Drug Administration) för att kunna få ett framtida godkännande av UBC® Rapid, bolagets snabbtest för blåscancer. Nu går bolaget vidare och förbereder kliniska studier i USA.

Gunnar Wahlberg appointed as acting CEO

The Board has appointed Gunnar Wahlberg as acting CEO.

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