Lab21 Ltd (Cambridge, UK), a specialist in personalized medicine and clinical diagnostics, has entered into an agreement with biotechnology company IntegraGen (Evry, France), to develop a microRNA assay for colorectal cancer. Financial details were not disclosed.
According to the agreement, Lab21 will develop a CE marked assay, using its proprietary SPARQ polymerase chain reaction (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. This microRNA biomarker might predict response to epidermal growth factor receptor (EGFR) inhibitor therapy in KRAS-wild type patients who have metastatic colorectal cancer.
SPARQ is a fifth generation real time polymerase chain reaction (PCR) technology developed by Cooperative Diagnostics and licensed by Lab21 for use worldwide as announced in January 2012. The technology provides high performance in terms of sensitivity and specificity and allows for rapid assay development.
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 help clinicians to identify KRAS wild type patients most likely to respond to treatment: improving outcomes, avoiding adverse reactions, and saving money in the healthcare system.
Bernard Courtieu, CEO of IntegraGen commented, ''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.''
Lab21 provides diagnostic products and services and supports blood bank screening, medical diagnostics, and drug discovery. Its products division is focused on infectious diseases for blood-banking and clinical markets. The company manufactures immunodiagnostic kits and reagents that are distributed internationally. Its clinical laboratory division has a growing test portfolio providing companion diagnostics and high technology molecular assays.
IntegraGen 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 company's aim is to offer clinicians new personalized tools for diagnosis, treatment, and therapy. The company has a wholly owned US subsidiary located in Cambridge (MA, USA).