Austin, Texas – March 22, 2010. Asuragen, Inc., a leader in the development of molecular diagnostics, announced today the appointment of Biomedical Diagnostics SA (BMD), a leading medical diagnostic company in Europe, as its exclusive distributor of Signature® Oncology Products in France. Asuragen’s Signature Oncology Portfolio comprises multiplex assays for the detection of mutations in solid and hematologic malignancies. These include a research assay* for KRAS and BRAF mutations, the LTx CE marked IVD assay to detect fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias, and an assay for the simultaneous detection of the most common NPM1 Mutations*. All these assays utilize multiplex RT-PCR followed by multiplex detection on the Luminex® 100 IS™ or 200™ System.
“As we expand our Signature Oncology Portfolio with the launch of our Signature KRAS/BRAF multiplex assay*, we are pleased to add a strong commercial partner like BMD to our growing network of international distributors,” said President, Rollie Carlson. “In addition, BMD will be supporting our efforts in establishing clinical validation sites for the Signature KRAS/BRAF assay in France.”
“We are pleased by the confidence granted to us by Asuragen for the exclusive distribution of their products developed on the Luminex platform. This partnership will enable BMD to enlarge its offering of very innovative products in the field of oncology diagnostics,” said BMD’s General Manager, Denis Fortier.
KRAS and BRAF are oncogenes involved in the epidermal growth factor receptor (EGFR) signaling pathway that controls cell proliferation, differentiation and apoptosis. Mutations in the KRAS and BRAF oncogenes are frequently found in human cancers, such as colorectal cancers and non-small cell lung cancers. KRAS mutations are predictive of patient response to anti- EGFR inhibitor therapies and BRAF mutations are strongly prognostic in metastatic colorectal cancer.
About Signature KRAS/BRAF*
Asuragen has developed the Signature® KRAS/BRAF Mutations assay (RUO) that can simultaneously detect 12 KRAS mutations in codon 12 and 13 and BRAF V600E using genomic
DNA. The Assay consists of multiplex PCR followed by amplicon detection by flow cytometry on the Luminex® 100 or 200 systems.
Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company’s diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, and the Signature® Oncology and Genetic Testing products. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit www.asuragen.com.
About Biomedical Diagnostics
BMD develops and markets advanced biological tools for the medical market. The company boasts a unique combination of experience, knowledge and understanding of the biological diagnostics field. Founded in 1986, BMD holds a leading position in the diagnostics market, offering a wide range of solutions for autoimmune diseases diagnosis. BMD also offers contract development for discovery teams (biotechs and academies) to develop, produce and bring to the market IVD Bio Markers Multiplexed tests in auto-immune diseases, oncology and infectious diseases or/and in collaboration with pharmaceutical companies (companion diagnostic). For more information, please visit www.bmd-net.com or contact us at firstname.lastname@example.org.
* For Research Use Only. Not For Use in Diagnostic Procedures.