Lab21 and IntegraGen are teaming up to develop a microRNA assay for colorectal cancer designed to further improve patient outcomes. Lab21 will develop a CE-marked assay using its 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. As most patients with metastatic colorectal cancer are currently screened and stratified by determining mutations in the KRAS gene, the companies say that 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. Following development of the assay, Lab21 and IntegraGen say they will explore other opportunities for partnerships relative to the manufacturing and commercialization of this oncology biomarker.

“We are pleased to be working with Lab21 to progress this biomarker toward commercialization in Europe,” Bernard Courtieu, CEO of IntegraGen, said. “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’s molecular diagnostics expertise was also tapped by BD last October, as the two companies collaborated on the development of oncology assays for the automated BD Max™ benchtop molecular testing system. Lab21 also recently added a new weapon to its arsenal, acquiring a worldwide license to use Cooperative Diagnostics’ real-time PCR technologies for the development of specific biomarker-based tests in the fields of oncology and infectious diseases.

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