Qiagen negotiated a nonexclusive license to Orion Genomics’ MethylScreen™ technology for research use in its EpiTect™ Methyl qPCR Array System reagent kits. The kits are used to analyze DNA methylation status of genes using qPCR. Qiagen says the MethylScreen technology has proven to be an essential component of its epigenetics tools including the EpiTect Methyl qPCR system.
Orion is leveraging its MethylScreen and MethylScope™ platforms for the development of epigenetic research tools and molecular diagnostics products. The MethylScreen clinical assay technology applies methylation-sensing restriction enzymes and real-time PCR to quantitatively detect epigenetic biomarkers in biological samples. MethylScope is a DNA methylation profiling tool designed to precisely map DNA methylation across entire genomes in order to enable the discovery of biomarkers for disease detection and therapy selection. The technology is in addition compatible with microarray, bead array, and ultra high-throughput DNA sequencing technologies, the firm says.
“Qiagen’s license validates the importance of MethylScreen technology in detecting DNA methylation-based biomarkers in biological samples,” comments Nathan D. Lakey, Orion president and CEO. “Qiagen’s distribution strength will further establish Orion’s innovation among scientists studying epigenetics.”
Orion’s molecular diagnostics unit is exploiting its platforms to develop epigenetic diagnostic products for identifying patients at risk of developing cancer, and to aid in therapy selection. The firm’s lead pipeline product, the Orion Colorectal Cancer Risk Test, is a blood test that detects loss of imprinting of the cancer-associated growth gene IGF2. The test is being developed on the back of growing evidence suggesting that individuals whose peripheral blood leukocytes exhibit loss of imprinting of IGF2 may be at elevated risk for developing colorectal cancer.
Orion is separately developing a urine-based screening test for diagnosing bladder cancer in high-risk patients, and a sputum lung cancer diagnostic. Both assays are based on relevant panels of biomarkers identified by the firm using its MethylScope platform. The firm says it has discovered over 150 novel biomarkers spanning a range of cancers, which have been validated in collaboration with the Mayo Clinic and the University of Glasgow in the U.K.
Ongoing collaborations include a multiyear partnership with Novartis Pharma, signed in 2009, through which the companies are using the MethylScope platform to discover novel epigenetic biomarkers in multiple disease fields. The agreement gives both firms rights to independently develop and commercialize diagnostic products in their respective fields. Novartis also retains nonexclusive worldwide rights to the MethylScreen clinical assay platform.