QIAGEN and Natera partner to develop cutting-edge genetic testing assays for use on QIAGEN’s GeneReader NGS System
Hilden, Germany, and San Carlos, CA, March 12, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA), a world leader in providing Sample to Insight molecular solutions, and Natera, Inc. (NASDAQ: NTRA), a leading developer of next-generation sequencing (NGS) assays that include non-invasive prenatal genetic testing and the analysis of circulating tumor DNA, today announced a partnership to develop cutting-edge cell-free DNA assays for use on QIAGEN’s GeneReader NGS System.
These cell-free DNA assays will now be developed for use on the GeneReader NGS System, the first fully integrated Sample to Insight NGS solution, and designed to enable these type of tests, including prenatal screening, for hospitals and laboratories globally. Natera’s Constellation™ software would also be accessible for users of these and other assays in combination with the QIAGEN Clinical Insights (QCI) bioinformatics solution.
“We are excited to partner with Natera, a global market leader in non-invasive cell-free DNA genetic testing. Through this strategic partnership, we are planning to offer assays that provide significant clinical and economic value backed by extensive validation data and large clinical studies. We intend to make these assays available on the GeneReader NGS System to laboratories around the world that are very eager to bring in-house genetic testing across several applications, including prenatal screening,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “The addition of these assays, along with Natera’s Constellation software, will substantially increase the system’s value and utility for a broader range of customers beyond the current menu focused on oncology.”
“This strategic partnership is an important milestone in the development of Natera, and we welcome the opportunity to partner with QIAGEN since both companies share a commitment to providing customers with actionable and often life-changing clinical insights,” said Matthew Rabinowitz, CEO of Natera. “We are combining Natera’s molecular and clinical experience in NGS content development with QIAGEN’s expertise in offering a complete and integrated NGS workflow to offer Sample to Insight testing leveraging Natera’s Constellation cloud platform. We also believe the global reach of QIAGEN will help us capitalize on the emergence and power of next-generation sequencing globally, and make these assays broadly accessible to hospital systems and laboratories worldwide.”
The partnership builds on Natera’s expertise in reproductive genetics and non-invasive cell-free DNA testing. This includes highly accurate and broad-coverage solutions for non-invasive prenatal testing (NIPT) such as Panorama® and Vistara™, Horizon™ genetic-carrier testing, Spectrum® preimplantation genetic testing (PGD/PGS), Anora® miscarriage testing, and recently the Signatera™ (RUO) high-sensitivity assay for use in oncology research.
The new NIPT assays will analyze non-invasive maternal blood samples and reflect the power of liquid biopsy to gain insights. Building on QIAGEN’s leading PAXgene blood cell-free DNA collection and sample processing technology, which is fully automated and integrated into the GeneReader NGS workflow, the tests are expected to selectively differentiate fetal placental DNA from the background of the mother’s DNA to test whether a baby is at higher risk for common genetic conditions. The Sample to Insight workflow will also provide personalized risk reports for healthcare and genetic counseling.
Under the 10-year agreement, QIAGEN will pay Natera $40 million in upfront licensing fees and prepaid royalties in the first quarter of 2018. Natera is also eligible for an additional $10 million of milestone payments, as well as ongoing royalty payments. Each company will bear its own development costs for the assay. Natera and QIAGEN will establish a complete Sample to Insight workflow with the GeneReader NGS System and validate the sample preparation workflow using the Constellation platform.
About the GeneReader system
The GeneReader NGS System provides the first true Sample to Insight NGS workflow for laboratories worldwide to take advantage of the power of NGS technology. The system’s integrated bioinformatics for analysis and interpretation of NGS data, as well as a family of gene panels under the GeneRead QIAact brand, enable laboratories to identify gene variations linked to cancers and gain actionable molecular insights. QIAGEN continues to add content for GeneReader, with a pipeline of potential future tests in areas such as oncology, prenatal testing, infectious disease genotyping, and customized panels for specific needs. Integrated bioinformatics provide streamlined, cloud-based analysis and interpretation. The current version of the GeneReader NGS System is available in the United States for research use only (RUO). For more information please visit www.genereaderngs.com.
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic disease. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize new product offerings, the success of our Constellation cloud-based distribution model; our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, the benefits of our screening tests and product offerings to patients, providers and payers, or our expectations regarding our strategic operations. Additional risks and uncertainties are discussed in greater detail in "Risk Factors” in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov
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 December 31, 2017, QIAGEN employed approximately 4,700 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).