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Qiagen, Helix announce global strategic partnership

Helix announced a global strategic partnership with Qiagen to jointly develop companion diagnostics for hereditary diseases. As part of the collaboration, Helix will leverage the Helix Laboratory Platform to develop companion diagnostics in the U.S., and Qiagen will use the QIASeq Human Exome Kits in the rest of world. The Helix Laboratory Platform is a whole exome sequencing platform run in Helix’s San Diego based CLIA / CAP next-generation sequencing lab and will be the basis for companion diagnostic development and earlier stage assay development in the United States. Helix is the first – and remains the only – company to receive De Novo Class II authorization of this platform from the U.S. FDA. Helix will develop companion diagnostics and clinical trial assays for all phases of clinical trials, as well as commercialize single site premarket approval companion diagnostics.

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