NEW YORK (GenomeWeb) — IntegraGen announced today that it has signed an agreement giving Laboratoire Cerba the right to develop a tumor expression test based on its microRNA biomarker miR-31-3p.
The miRNA biomarker is exclusively licensed to IntegraGen and has been shown to be a predictive biomarker of EGFR-inhibitor response in KRAS wild-type metastatic colorectal cancer patients. IntegraGen is currently testing the biomarker in the clinic to see if it can be used to identify patients who will respond to such anti-EGFR therapies.
Under the terms of the agreement, Laboratoire Cerba has the right to set up, validate, and run a miR-31-3p test in its clinical reference lab, an IntegraGen spokesperson said in an email. He added that Laboratoire Cerba will focus its marketing efforts on clinicians in France, Belgium, the Netherlands, Luxembourg, the Middle East, and Africa.
Additional terms of the deal were not disclosed.
The spokesperson noted that IntegraGen is continuing development of its own kit to measure miR-31-3p levels in formalin-fixed, paraffin-embedded samples, which it aims to market to hospitals and labs in the EU as miRpredX 31-3p. CE marking for the kit is expected by the end of the second quarter.
IntegraGen is also on the lookout for a CLIA lab partner to license the test and sell it as a laboratory-developed test in the US, he wrote.
"This new partnership with Laboratoire Cerba is a significant achievement for IntegraGen since it is a major step for the company's diagnostics activities," IntegraGen CEO Bernard Courtieu said in a statement. "With the launch of our first proprietary test in Europe, it also represents the culmination of more than five years of research and development efforts, from the early stages of biomarker discovery to the availability of a miR-31-3p expression test for oncologists and patients."