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IntegraGen Announces Publication of Study with Biomarker Associated with Survival in Metastatic Colorectal Cancer Patients Treated with Drug Therapy

IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in oncology and autism, recently announced the publication of a study in Clinical Cancer Research which reports on the ability of the microRNA (miRNA) miR-31-3p to predict progression-free survival in KRAS wild-type (WT) metastatic colorectal cancer (mCRC) patients treated with anti-epidermal growth factor receptor (EGFR) antibodies.

IntegraGen Collaborating with New EPOC Study Investigators to Validate Metastatic Colorectal Cancer Biomarker

IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in oncology and autism, recently announced a collaboration with investigators from the New EPOC study to validate the oncology biomarker hsa-miR-31-3p, a microRNA whose expression has been shown to be a predictor of progression free survival in patients with metastatic colorectal cancer treated with anti-EGFR therapy.

IntegraGen Obtains Exclusive License for MicroRNA Which Predicts Therapy Outcomes in Metastatic Colorectal Cancer

IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in oncology and autism, recently announced that it has finalized an agreement providing the company with exclusive licensing rights for the oncology biomarker hsa-miR-31-3p, a microRNA whose expression has been shown to be a predictor of progression free survival in patients with metastatic colorectal cancer treated with anti-EGFR therapy. This exclusive license is based on original research led by Professor Laurent-Puig, M.D., Ph.D., Professor, Department of Genetics and head of the Clinical Oncogenetic Unit at European Georges Pompidou Hospital University Paris Descartes in Paris, France. IntegraGen obtained the exclusive license for the worldwide rights for this biomarker from the Paris Descartes University, INSERM, the Centre National de la Recherche Scientifique, and the Assistance Publique – Hopitaux de Paris, all leading French academic institutions which, along with IntegraGen, are co-owners of the patent.

Lab21 and IntegraGen Partner to Develop New Colorectal Cancer Diagnostic

Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, recently 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.

Source: Business Wire

IntegraGen Launches ARISk Test, a Genetic Screening Tool for Autism in High-Risk Children

IntegraGen, Inc., a biotechnology company dedicated to molecular biomarker discovery, today announced the launch of the ARISk™ Risk Assessment Test, a gender specific, genetic screening test that looks at 65 genetic markers associated with Autism Spectrum Disorder (ASD). The test is designed to assess the risk of autism in children from multiplex families—siblings of children with ASD who are 6 to 30 months of age. According to the Centers for Disease Control (CDC), the average age of diagnosis for ASD is 4.0 years, despite conclusive evidence that early intervention can significantly improve IQ scores, language and social skills, and ensure best possible outcomes.