Diagnostic products and services provider Lab21 and IntegraGen have entered into a partnership agreement for the development of a microRNA assay for colorectal cancer.
Under the agreement, Lab21 will use its proprietary SPARQ PCR technology to develop a CE-marked assay for the detection of expression levels of a microRNA biomarker known as hsa-mir-31-3p, discovered and patented by IntegraGen and its academic partners.
Early research conducted on the biomarker has shown that it may predict response to EGFR inhibitor therapy in KRAS-wild type patients with metastatic colorectal cancer.
MicroRNA expression testing also helps clinicians to identify the KRAS-wild type patients most likely to respond to treatment, including improving outcomes, avoiding adverse reactions and saving money in the healthcare system, according to IntegraGen.
Lab21 CEO Graham Mullis said; "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."
Financial details of the agreement have not been disclosed.
IntegraGen CEO Bernard Courtieu said the company is pleased to work with Lab21 to progress the 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," Courtieu said.
Following the development of the assay, Lab21 and IntegraGen will explore other opportunities for partnerships relative to the manufacturing and commercialisation of the oncology biomarker.