QIAGEN collaborates with BioNTech on companion diagnostics development for HPV-associated squamous cell carcinoma of the head and neck
Nov 18 2020

QIAGEN collaborates with BioNTech on companion diagnostics development for HPV-associated squamous cell carcinoma of the head and neck

• QIAGEN and BioNTech to develop tissue-based therascreen® test covering a panel of HPV genotypes, paired with investigational treatment BNT113, to identify patients whose cancers are caused by HPV infections
• QIAGEN to pursue global regulatory approvals, including Premarket Approval from FDA for companion diagnostics
• Collaboration leverages QIAGEN´s global reach and market-leading position in companion diagnostics and HPV testing

Hilden, Germany and Germantown, Maryland, November 18, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a strategic collaboration with BioNTech SE (Nasdaq: BNTX) to develop and commercialize a tissue-based companion diagnostic – to be used with investigational cancer treatment BNT113 – which identifies patients with squamous cell carcinoma of the head and neck (SCCHN) that are caused by specific infections by human papilloma virus (HPV).

The assay will detect the presence of HPV genotypes and will be developed on QIAGEN´s RGQ MDx platform, a member of the QIAsymphony family of products.

QIAGEN plans to expand the panel for use across HPV-driven cancers such as cervical cancer and other cancers, in order to provide a universal HPV companion diagnostic (CDx) for QIAGEN’s pharmaceutical partners.

Head and neck squamous cell carcinoma is the sixth most common cancer. Every year, there are more than 650,000 cases leading to 330,000 deaths, according to a 2018 global cancer study. These numbers are expected to double by 2035, according to the World Health Organization. The incidence of HPV-related SCCHN has significantly increased in recent years.

QIAGEN established the global HPV testing market over two decades ago. More than 100 million women have been tested for HPV infections using QIAGEN´s portfolio of HPV products, including hybrid capture, genotyping, and methylation tests.

“This CDx project will help to identify patients who might benefit from BioNTech´s innovative BNT113 treatment option,” said Jean-Pascal Viola, Senior Vice President and Head of Molecular Diagnostics Business Area at QIAGEN. “QIAGEN’s Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to aid in evaluating patients with squamous cell carcinoma of the head and neck. We will leverage our world-leading position in HPV testing to commercialize the new HPV companion diagnostics in all target markets of BioNTech.”

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer.

QIAGEN has an unmatched depth and breadth of technologies from polymerase chain reaction (PCR) to next-generation sequencing (NGS) for companion diagnostic development. These capabilities, such as the flexibility to tailor a CDx to a partner’s needs, IVD development expertise, and a proven global commercialization track record, allow QIAGEN to develop novel and innovative diagnostic solutions, including customized NGS products. Through the Day-One Lab Readiness program, a network of laboratories are ready for commercial testing, pending drug regulatory approval, allowing patients to benefit from immediate access to a therapeutic. 

Currently, QIAGEN is working under master collaboration agreements with more than 30 companies, including BioNTech, to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2020, QIAGEN employed more than 5,300 people in over 35 locations worldwide. Further information can be found at 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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