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Qiagen, Helix Partner for Hereditary Disease CDx Development

NEW YORK – Helix and Qiagen have formed an exclusive global partnership to develop and commercialize companion diagnostics for hereditary diseases, the firms announced on Thursday. Financial terms of the partnership were not disclosed.

The collaboration will address the health burden of hereditary neurodegenerative, cardiovascular, autoimmune, and inflammatory diseases, the firms said in a statement.

Specifically, the partnership will leverage Helix's whole-exome sequencing platform run at its San Diego lab to develop companion diagnostics and early-stage assays in the US for clinical trials, with the goal of commercializing single-site companion diagnostics with premarket approval from the US Food and Drug Administration. Qiagen, meanwhile, will use its QiaSeq Human Exome Kits in the rest of world and incorporate its biopharma relationships, next-generation sequencing capabilities, and global regulatory expertise.

Qiagen CEO Thierry Bernard said in a statement that the partnership "represents another step toward bringing the power of companion diagnostics to hereditary diseases." Furthermore, access to a genomic database like Helix's can help researchers find patients with particular biomarker signatures "almost instantaneously, making trial recruitment a matter of months instead of years," Bernard said.

Qiagen boasts 11 PCR-based companion diagnostics cleared by the FDA and recently announced a collaboration with Neuron23 to develop an NGS-based companion diagnostic for a novel Parkinson's disease drug. 

"Helix's technology and regulatory capabilities coupled with Qiagen's well-established worldwide companion diagnostic development capabilities results in a powerful partnership that will allow us to expand critical access to genomic testing for both patients and providers working daily to fight life-threatening conditions," Helix CEO and Cofounder James Lu said in a statement.

The companies said they will provide more details about the collaboration at the JP Morgan Health Care Conference next week.