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Press Release

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QIAGEN and Helix launch exclusive partnership to advance next-generation sequencing companion diagnostics in hereditary diseases

January 5, 2023
  • Partnership to leverage the Helix® Laboratory Platform powered by QIAGEN’s biopharma relationships, NGS capabilities, and global regulatory expertise
  • Addressing health burden in neuro-degenerative diseases, cardio-vascular diseases, and auto-immune and inflammatory diseases that affect hundreds of millions globally
  • Combined offerings include accelerated patient recruitment, real world evidence and diagnostic solutions using NGS and PCR technologies

QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) today announced an exclusive strategic partnership with California-based population genomics leader Helix to advance companion diagnostics for hereditary diseases.

As the development of precision medicines accelerates, so does the need for companion diagnostics devices and tests detecting clinically relevant genetic abnormalities. These diagnostics help guide clinical decision-making by identifying patients most likely to benefit – or be at increased risk – from a particular therapeutic product. Principally used in oncology to date, companion diagnostics that employ whole exome sequencing are widely believed to have great potential in hereditary disease areas such as cardiovascular, metabolic, neuro-degenerative, and auto-immune diseases.

Under the agreement announced today, QIAGEN will be the exclusive marketing and contracting partner in the U.S. for Helix’s companion diagnostic services. The partnership will leverage the Helix® Laboratory Platform, which was granted the first-ever U.S. Food & Drug Administration de novo class II authorization for a whole exome sequencing platform. This brings a new innovative solution to biopharmaceutical customers in support of hereditary disease therapies, complementing solutions both companies already provide such as Helix’s population genomics programs and QIAGEN’s diagnostic expertise, QIAseq Human Exome Kits and global reach supporting research initiatives outside the U.S.

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.

“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.”

“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.”

Helix has built an end-to-end platform that 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 non-alcoholic steatohepatitis (NASH), power real-world data (RWD) or real-world evidence (RWE) services and insights, and bring deep genetic expertise and methodologies to examine sub-cohorts within both drug discovery and a clinical trial.

About Helix

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.

About QIAGEN

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 http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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