Lab21 and IntegraGen Partner to Develop New Colorectal Cancer Diagnostic
News Feb 26, 2013
Lab21 Limited 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 recognized 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 commercialize 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 commercialization 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 commercialization of this novel oncology biomarker.
Breath Test Could Simplify Drug and Disease TestingNews
Testing for drug use and disease in humans could soon be much simpler, thanks to new Swedish research.Scientists have demonstrated how collecting and analysing externally-produced compounds in the lining fluid of the airways allows for non-invasive testing and monitoring.The researchers used liquid chromatography-mass spectrometry to analyse the collected samples, as well as investigating the impact of different breathing patterns.READ MORE
Agent Reverses Resistance to Targeted Drug in Some LeukemiasNews
After discovering how some hematologic cancer cells manage to elude death from a targeted therapy, Dana-Farber Cancer Institute scientists have double-crossed the cancer cells with a drug that renders them vulnerable to the targeted agent.READ MORE
Blueprints for Anti-cancer Drugs Identified in Bacterial GenomesNews
Scientists have now brought the family of LNM molecules even closer to clinical testing by “mining” the information stored in bacteria genomes. Their research suggests these hidden genes hold the blueprints for designing new, even more effective cancer-targeting compounds.READ MORE