CAMBRIDGE, England--()--Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, has entered into an agreement with IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in autism and oncology, 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.
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 (i.e. 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.
Lab21 is a global leader in personalised healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products Division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. The Clinical Laboratory Division has a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley and Bridport. Website: www.lab21.com
Founded in 2000, IntegraGen (ALINT.PA) is a biotechnology company specialized in the research and identification of genetic biomarkers for the development and marketing of products and services for molecular diagnosis. The IntegraGen mission is to offer clinicians new personalized tools for diagnosis, treatment and therapy. The company is headquartered in Evry, France and has a wholly-owned US subsidiary is located in Cambridge, Massachusetts. IntegraGen’s goal is to assist in the prevention and proactive management of complex, debilitating illnesses by delivering the best response to the needs of patients, clinicians and associations. The Business Genomic Services division at IntegraGen also provides cutting edge services in the genotyping domain for scientific research. With research and intellectual property aimed essentially at autism and oncology, IntegraGen’s strategy is to offer a range of products and services for molecular diagnosis incorporating strong added value, favoring personalized medicine for complex illnesses.
For more information on IntegraGen visit www.integragen.com.