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GEN News Highlights : Mar 23, 2011

Asuragen Achieves CE Mark for AmplideX Genetic Test for Fragile X Syndrome

Company says distributors are already in place to effect immediate product launch.

Asuragen has commercially launched its AmplideX™ fragile x test in Europe on the back of CE-mark approval. The FMR1 PCR Kit has been developed to detect CGG repeats in the fragile X mental retardation (FMR1) gene, and can be used to aid in the diagnosis of associated disorders including fragile X-associated primary ovarian insufficiency, and fragile X-associated tremor/ataxia syndrome. Asuragen claims the assay can help reduce the need for Southern blot testing by some 98%.  

The AmplideX test will be available through Asuragen’s recently established network of European distributors. “Our distribution partners will also serve a critical role in accelerating clinical validation and CE-marking of our portfolio of molecular diagnostic products,” notes Rollie Carlson, Ph.D., Asuragen president.

Molecular diagnostics company Asuragen is exploiting its specialist mRNA and miRNA expertise to develop oncology and companion diagnostic tests, and also offers RNA stabilization technologies, and controls and standards engineered using its Armored RNA® technology.

The firm’s Signature® range of oncology tests includes the Signature LTx v2.0 test, for the detection and identification of fusion transcripts from common chromosome translocations and abnormalities associated with CML, ALL, APL, and AML. The Signature NPM1 Mutations (RUO) test is designed to simultaneously detect the most common exon 12 nucleophosmin (NPM1) gene mutations in AML. The Signature KRAS/BRAF Mutations assay is a research tool for detecting KRAS and BRAF cancer mutations in genomic DNA extracted from human cell lines or fresh, frozen or fixed tissues.

Asuragen also operates a pharmacogenomic services division that provides nucleic acid-based services, including analyte isolation/preparation from multiple sample types, genomic profiling, miRNA/mRNA expression profiling, biomarker discovery, assay design, and validation, CLIA-based clinical testing, bioinformatics, and regulatory and project management services. Asuragen also offers a full range of contract RNA manufacturing services and GMP contract manufacturing for in vitro synthesized RNA for use in vaccines.