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Asuragen to Develop IVD Kits on Thermo Fisher Scientific's CE Platform

NEW YORK (GenomeWeb) – Asuragen said today that it is collaborating with Thermo Fisher Scientific to develop and commercialize capillary electrophoresis-based in vitro diagnostics.

Asuragen, based in Austin, Texas, will develop diagnostic kits for Thermo Fisher’s 3500 Dx Series Genetic Analyzer CS2 instrument, using its AmplideX PCR/CE technology, which enables the analysis of repetitive DNA sequences, and its AmplideX Reporter analytics and reporting software. The products will be built under design control and manufactured at Asuragen's cGMP facility.

The company is not disclosing details of the assay used in the kits at this time or which diseases they will diagnose. Asuragen currently offers AmplideX PCR/CE research products to detect CGG repeats in the fragile X mental retardation gene (FMR1) and to detect hexanucleotide repeats in the C9orf72 gene, which has been implicated in frontotemporal dementia.

According to Matt McManus, president and CEO of Asuragen, repetitive sequences and short structural variations are "not well served" by current diagnostic technologies, including next-generation sequencing. "The combination of Thermo Fisher's capillary electrophoresis instruments' performance and our novel AmplideX chemistries provides the level of resolution required for these emerging biomarkers," McManus said in a statement.

"Asuragen is recognized for delivering high performance and quality molecular diagnostic products in the fields of genetics and oncology. We look forward to working with them on products serving significant clinical needs," said Kim Kelderman, vice president and general manager for the genetic analysis business at Thermo Fisher Scientific, in a statement.