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Lab21, IntegraGen Co-developing CDx for Colorectal Cancer Therapy

NEW YORK (GenomeWeb News) – Lab21 today announced an agreement with IntegraGen to develop a microRNA-based assay to identify colorectal cancer patients who may best respond to EGFR-inhibitor therapy.

Lab21 will develop an assay based on its SPARQ PCR technology to detect the expression levels of a miRNA biomarker called hsa-mir-31-3p. IntegraGen and its academic partners discovered and patented the biomarker, which has shown an ability to predict EGFR-inhibitor response in KRAS wild-type patients with metastatic colorectal cancer.

Lab21 said that most patients with the cancer are already screened and stratified by determining mutations in the KRAS gene. About 40 percent of patients have a KRAS mutation and are not suitable for treatment with EGFR inhibitors. Of the remaining colorectal cancer patients without a KRAS mutation and who are eligible for EGFR-inhibitor therapy, only 50 to 60 percent respond to the therapy.

MiRNA expression testing would provide an additional level of stratification and further help clinicians identify those patients who would be best candidates for the therapy, improving outcomes while saving costs to the healthcare system, Lab21 said.

Last year the US Food and Drug Administration approved a companion diagnostic test from Qiagen for Erbitux (cetuximab), an EGFR inhibitor marketed in the US by Bristol-Myers Squibb along with Eli Lily and its Imclone Systems unit. Outside of the US and Canada, the drug is sold by Germany's Merck KGaA.

"On the basis of good clinical results and regulatory approval, we hope to have a CE-marked kit available based on Lab21's technology by early 2014," Bernard Courtieu, CEO of IntegraGen, said in a statement. "With over 500,000 patients diagnosed with metastatic colorectal cancer annually on a global basis, there is a large market potential for an assay based on this biomarker."

Financial and other terms of the deal were not disclosed.

Cambridge UK-based Lab21 is a personalized diagnostics company. In October it reached a deal with Becton Dickinson to develop oncology assays with an initial focus on KRAS and BRAF mutations.

IntegraGen is based in Evry, France and develops molecular diagnostics with a focus on oncology and autism.