Helix, a population genomics and viral surveillance company, announced a global strategic partnership with QIAGEN N.V., a global provider of sample-to-insight solutions, 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 received De Novo Class II authorization of this platform from the U.S. Food & Drug Administration (FDA). Helix will develop companion diagnostics and clinical trial assays for all phases of clinical trials, as well as commercialize single site premarket approval (PMA) companion diagnostics.

“This partnership represents another step toward bringing the power of companion diagnostics to hereditary diseases by powering Helix’s leading products with QIAGEN’s extensive pharma and biopharma relationships, NGS capabilities, and global regulatory expertise,” says Thierry Bernard, CEO, QIAGEN. “Access to a genomic database can help researchers find patients with particular biomarker signatures almost instantaneously, making trial recruitment a matter of months instead of years.”

QIAGEN has more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests for their drug candidates. QIAGEN’s companion diagnostic offerings encompass technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR), sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson’s, including 11 FDA-approved PCR based companion diagnostics and a collaboration with Neuron23 announced in September 2022 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,” says Helix CEO and Co-Founder, James Lu, MD, PhD. “QIAGEN’s mission to fill the clinical gap for patient access and provide technology platform options to address the needs of physicians to target treatment with genomic medicine is well in line with our mission.”