Pharma Focus Europe

Helix and QIAGEN Form Exclusive Global Partnership to Develop and Commercialize Companion Diagnostics for Hereditary Diseases

Friday, January 06, 2023

Helix, the leading population genomics and viral surveillance company in the nation, announced today a global strategic partnership with QIAGEN N.V., the leading 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 is the first - and remains the only - company to receive 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," said Thierry Bernard, Chief Executive Officer of 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."

A pioneer in precision medicine, 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.

Leveraging an end-to-end platform, Helix enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Helix has partnered with leading health systems to enable population genomics programs of at least 100,000 patients each across the U.S. These programs dramatically accelerate patient identification and recruitment for clinical trials in hereditary diseases such as Parkinson's, cardiovascular or inflammatory disease like nonalcoholic steatohepatitis (NASH), power real world data or real-world evidence (RWD/RWE) services to generate high value insights, and bring deep genetic expertise and methodologies to examine sub cohorts both in early drug discovery and within a clinical trial.

"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," said 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."

The two companies will be providing more detail about their collaboration at the 41st Annual JPMorgan Health Care Conference in San Francisco this month.

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