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.
Most patients with metastatic colorectal cancer are currently screened and stratified by determining mutations in the KRAS gene. Approximately 40% of these patients carry a KRAS mutation and are not candidates for EGFR inhibitor therapy. Of the approximately 60% of patients who do not carry a KRAS mutation (ie KRAS wild type) and who are eligible for EGFR inhibitor therapy, effectiveness is still only 50-60%. MicroRNA expression testing may provide a further level of stratification and thus aid clinicians to identify KRAS wild type patients most likely to respond to treatment: improving outcomes, avoiding adverse reaction and saving money in the healthcare system.
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.