Partnership to Develop Colorectal Cancer Assay

Lab21 Limited, a global specialist in personalised medicine and clinical diagnostics and IntegraGen, a leading player in the field of molecular diagnostic testing in autism and oncology, are partnering to develop a microRNA assay for colorectal cancer designed to further improve patient outcomes.

Under the agreement, Lab21 will develop a CE marked assay, using its proprietary SPARQ™ PCR technology, to detect expression levels of a microRNA biomarker called hsa-mir-31-3p, which was discovered and patented by IntegraGen and its academic partners.  Early research with this biomarker has shown that it may predict response to EGFR inhibitor therapy in KRAS-wild type patients who have metastatic colorectal cancer.  Financial details were not disclosed.

Graham Mullis, CEO of Lab21, commented: “We are delighted to enter into this assay development agreement with IntegraGen. Lab21’s experience in developing molecular diagnostics in the oncology and infectious disease settings is increasingly being recognised by major diagnostic manufacturers and pharmaceutical partners. The combination of our highly efficient assay development capability, regulatory and manufacturing know-how is actively being sought by developers of novel diagnostics, such as IntegraGen, who need partners to commercialise their biomarkers, including a route to market.”

Bernard Courtieu, CEO of IntegraGen, added: “We are pleased to be working with Lab21 to progress this biomarker towards commercialisation in Europe. 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. 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.”

Following development of the assay, Lab21 and IntegraGen will explore other opportunities for partnerships relative to the manufacturing and commercialisation of this novel oncology biomarker.