Hilden, Germany, and Germantown, Maryland, November 20, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an agreement with LabCorp® (NYSE: LH) to extend their current QIAGEN Clinical Insights (QCI) license with QIAGEN’s Human Gene Mutation Database (HGMD) of human genetic variants, the world’s largest database of inherited disease mutations. This agreement builds on the existing seven-year relationship between the two companies to develop, introduce and support new diagnostic tests. LabCorp will use HGMD across its network of laboratories to improve identification and interpretation of genetic variants within inherited diseases.
“Next-generation sequencing has become a powerful tool to identify genetic variants that play a role in inherited diseases, providing a flexible technology platform that allows us to go from large-scale to highly targeted test panels that can be used for both clinical diagnostics and in studies of new therapies and diagnostics,” said Marcia Eisenberg, Ph.D., Chief Scientific Officer for LabCorp Diagnostics. “Having access to the most comprehensive and up-to-date catalog of known mutations augments our existing variant classification expertise. This will allow us to continue to provide physicians and researchers with the best possible test interpretations, advancing LabCorp’s mission to improve health and improve lives.”
“Rare and hereditary diseases often create a difficult diagnostic odyssey for patients, families and healthcare systems. LabCorp recognizes this challenge. Extending access to HGMD, a component of QCI, will benefit both labs and patients waiting for answers related to hereditary diseases and appropriate treatments,” said Jonathan Sheldon, Ph.D., Senior Vice President and Head of QIAGEN’s Digital Insights Business Area. “We have a longstanding relationship with LabCorp and are delighted to extend it. The expansion validates the importance of QIAGEN’s bioinformatics solutions in the interpretation of germline diseases. QCI with the inclusion of HGMD, and supporting automation capabilities, enables more informed and confident decisions for any indication, germline or somatic for all clinical testing labs.”
“QIAGEN’s HGMD provides us with access to curated, peer-reviewed evidence that will support more precise, comprehensive variant interpretation,” said Stan Letovsky, LabCorp’s Vice President of Data Sciences and Bioinformatics. “Pairing that with QIAGEN’s automated and scalable informatics framework facilitates our day-to-day secondary and tertiary bioinformatics analyses, and will help improve the quality of care for patients.”
Hereditary diseases affect more than 20 million people in the United States. Despite major technological advances that enable the cost-effective generation of large datasets that encompass all coding regions, including entire human genomes, challenges in linking a patient’s genetic variants to the growing body of knowledge of human disease genetics signifies that genetic testing often does not produce actionable information to guide diagnosis and better treatment decisions. This contributes to the difficult journey that patients and their families undergo and underscores the need for knowledge that will enable prioritization and interpretation of genetic variants that are linked to specific diseases.
HGMD is a leading repository for heritable mutations. With over a quarter of a million mutations and thousands more added quarterly, HGMD provides the evidence needed to transform variant data to actionable insights for researchers, physicians, and most importantly, patients. Cited in 17,000+ publications, this easy to use database provides access to over 260,000 detailed mutation reports, 18,000 added each year, and more than 10,500 summary reports listing all known published inherited disease mutations. HGMD is included within the QIAGEN Knowledge Base which powers QIAGEN Clinical Insight-Interpret, a clinical decision support platform that offers evidence-based interpretation for germline or somatic indications. For more information please visit: https://www.qiagenbioinformatics.com/products/human-gene-mutation-database/
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 June 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11 billion in 2018. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about Covance Drug Development, visit www.Covance.com.
QIAGEN Forward Looking Statements
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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, 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; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).
LabCorp Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements with respect to scientific collaborations, customer contracts and relationships, the anticipated benefits of such collaboration and relationships, and the expected impact that the various collaborations and customer relationships may have on LabCorp’s (the Company’s) financial results. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company’s control, including without limitation, the Company’s ability to establish and maintain strategic partnerships and other scientific collaborations, competitive actions in the marketplace, and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, adverse actions of governmental and other third-party payers, patient safety issues, changes in testing guidelines or recommendations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement the Company’s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company’s other filings with the SEC.