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

• Partnership to leverage the Helix^® Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise
  
  
• Addressing health burden in neuro-degenerative diseases, cardiovascular diseases, and auto-immune and inflammatory diseases that affect hundreds of millions globally
  
  
• Complementary to the products and services both companies offer including accelerated patient recruitment, real world evidence, research services leveraging clinico-genomic datasets and diagnostic solutions using NGS and PCR technologies

SAN MATEO, Calif. And VENLO, The Netherlands, Jan. 5, 2023 /PRNewswire/ -- Helix, the leading population genomics and viral surveillance company in the nation, announced today a global strategic partnership with QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA), 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.

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2022, QIAGEN employed more than 6,200 people in over 35 locations worldwide. Further information can be found at https://www.qiagen.com. 

Helix is the leading population genomics and viral surveillance company operating at the intersection of clinical care, research, and data analytics. Helix enables health systems, life sciences companies, payers, and government partners to accelerate the integration of genomic data into patient care and public health decision making. Through its human and viral genomic programs, Helix supports the therapeutic development lifecycle by accelerating clinical trials and by providing real world data and real-world evidence services that generate high value insights related to hereditary and infectious disease therapies. Learn more at www.helix.com.

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