QIAGEN expands biomarker content portfolio to support greater use of molecular diagnostics for immuno-oncology therapies
Option to add new biomarkers for microsatellite instability (MSI) and mismatch repair (MMR) to QIAGEN's NGS panels
Hilden, Germany, and Germantown, Maryland, June 3, 2017 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received a worldwide license from The Johns Hopkins University for biomarkers that have been shown to play key roles in identifying patients who could benefit from novel immune-oncology (I-O) therapies in cancer treatment.
The agreement involves rights to genetic biomarkers to assess microsatellite instability (MSI) and mismatch repair (MMR) in all sample and cell types, and will enable QIAGEN – subject to its exercising certain option rights – to commercialize molecular testing solutions using next-generation sequencing to assess MSI and MMR status. Levels of MSI and MMR, along with tumor mutation burden (TMB), are important in identifying cancer patients who could benefit from certain types of I-O therapies, which offer a novel way to treat cancer by using drugs to target the body’s immune system to help fight cancer.
QIAGEN reached this agreement prior to the U.S. Food and Drug Administration’s (FDA) approving in May 2017 an I-O therapy to treat advanced solid tumors with MSI and MMR deficiencies, marking the first time that the FDA has cleared a cancer drug for use not tied to the site of a tumor. The Johns Hopkins University has been at the forefront of research in linking MMR defects to cancer.
“QIAGEN is constantly seeking out novel approaches to strengthen our portfolio of Sample to Insight solutions to support cancer research and better outcomes for patients, and the addition of these biomarkers are expected to play an increasingly important role in decision-making on the use of immuno-oncology therapies,” said Jonathan Arnold, Vice President and Head of Partner for Precision Diagnostics at QIAGEN. “We will evaluate all our technological options to offer MSI / MMR and TMB testing, including QIAseq panels that can be processed on our NGS platform. Working closely with our partners in the pharmaceutical industry, we intend to commercialize companion diagnostics and complementary diagnostics that will further strengthen QIAGEN’s global leadership in this area.”
QIAGEN is at the forefront globally in developing Personalized Healthcare assays using genomic insights along the patient care continuum, especially to guide the selection of medicines for cancer and other diseases as well as for disease monitoring. QIAGEN already offers a portfolio of Personalized Healthcare assays covering about 30 biomarkers, spanning a variety of automation platforms and biological sample types. Furthermore, QIAGEN is working with partners on ways for its QuantiFERON Monitor (QFM), a novel diagnostic for monitoring immune function, to be used as part of the diagnostic review of patients being considered or treated with I-O therapies. QFM measures the cell-mediated immune response and can provide important information on the strength of the immune system in an immunosuppressed patient.
QIAGEN also currently has more than 20 master collaboration agreements with leading pharmaceutical and biotech companies worldwide under which QIAGEN develops companion diagnostics assays to guide the use of therapies for treatment of cancers as well as other diseases.
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 (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2017, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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).