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13. September 2012: The board of directors of NORDA has decided to continue the development of the Genefec test, and has engaged the IKFE GmbH in Germany to finalize the test for international licensing. The contract includes CE approval for the Genefec kits, and clinical production test during a test market period.

Genefec CRC screening test
Colorectal cancer (CRC) is one of the most common cancer diseases in the world. The disease is easy to cure if treated at an early stage. The standard methode to diagnose CRC is by colonoscopy, which is a invasive inspection of the colon. The Genefec test is a non invasive CRC test based on stool samples.

In 2008 NORDA (former NorDiag) arranged for a large clinical study, 700 patients, in Germany, which studied the sensitivity and specificity of a Genenfec CRC test, containing several markers. The test performed significantly better than competing non invasive tests, but the COGS at the time made the test dependant on reimbursement.  Due to new methods and key technologies coming of patent, the cost of the Genenfec CRC test has decreased substantially.  Norda is therefore of the opinion that the new Genenfec CRC test can be introduced to the market as a patient pay screening test without reimbursement.  NORDA is optimistic about the international potential for test and plans a test market launch in Germany during 2013.

IKFE GmbH,Germany
The institute for clinical research and development in Mainz (ikfe GmbH) offers full-service development support for drugs and medicinal products. With its own clinic, contract research organization, and laboratory, the ISO 13485 certified institute has a particular expertise in the development of in-vitro diagnostic (IVD) test methods. Short timelines from bench to market have been demonstrated already in similar previous IVD developments. Prof. Andreas Pfützner, MD, PhD, CEO of IKFE and leading internal scientist for the GeneFec development stated: "Genefec is an exciting product idea and we are looking forward to support NORDA with our expertise to finish the last product development steps and achieve CE-mark and regulatory approval in a near-term future". 

For further information, contact :
Managing director Hans Hekland, phone : +47 906 26 870

Read the notice in Norwegian here.