QIAGEN and LabCorp launch collaboration to provide Day-One access for patients to innovative companion diagnostics at the time of drug approvals

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a master service agreement with LabCorp® (NYSE: LH) to further accelerate the access of cancer patients to QIAGEN’s companion diagnostic products following regulatory approvals of drugs and their associated tests.

As a new participant in QIAGEN’s Day-One Lab Readiness program, LabCorp will be able to provide physicians and patients with faster access to new, genomically targeted drugs that are becoming increasingly important therapies for a growing variety of cancers. LabCorp is the latest company to join the program, and its expertise in the commercial use of companion diagnostics will help a broader range of patients gain access to innovative tools for precision medicine.

Building on the U.S. Food and Drug Administration’s modernized regulatory approach, QIAGEN´s Day-One Lab Readiness program enables molecular diagnostic labs to begin implementing the activities necessary to prepare for commercial launch of new drugs and IVD tests once FDA approval is obtained.

LabCorp’s participation in QIAGEN´s network of laboratory partners will contribute to ensuring testing readiness for a portfolio of new companion diagnostics, including tests based on next generation sequencing (NGS) and qualitative polymerase chain reaction (qPCR), being prepared for launches in 2019 and 2020 in several countries around the world. 

As more biomarkers and new technologies are used to develop in vitro diagnostics (IVD), companion diagnostic testing is becoming increasingly complex. LabCorp’s extensive experience in these areas is a strong complement to QIAGEN’s personalized health collaborations with leading pharmaceutical companies. Assays for multiple indications, including novel companion diagnostics across a range of cancers including lung, breast, colorectal, bladder and eventually pan-tumor disease areas, are currently in LabCorp’s Day-One Lab Readiness pipeline.

“Our Day-One Lab Readiness program covers all the steps in being able to begin serving patients with access to companion diagnostic results immediately upon approval of new targeted therapies and the related companion diagnostics. Our Day-One program includes pre-approval preparation of workflow implementation, training, assay verification, forecasting, medical communication and reimbursement to ensure immediate readiness,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “LabCorp has a broad global presence and deep involvement in clinical testing, and we have a long history of working together. Day-One Readiness marks a new level of our successful collaboration with LabCorp, which already ensures patient access to several precision diagnostic tests, including therascreen® assays for oncology and also NGS solutions. By aligning the timelines of LabCorp and our partners, we can bring new treatment options to market earlier.”

“LabCorp’s expanded collaboration with QIAGEN builds on our leading position in companion diagnostics, and it allows us to make those precision tests and new targeted drugs available sooner to physicians and patients,” said Marcia Eisenberg, Ph.D., Chief Scientific Officer of LabCorp Diagnostics. “This is perfectly aligned with LabCorp’s mission to improve health and improve lives by delivering world-class diagnostics, bringing innovative medicines to patients faster, and using technology to improve the delivery of care. LabCorp Diagnostics and our Covance Drug Development business already work closely with QIAGEN and its pharma partners on multiple oncology biomarker and clinical trial programs, and we are pleased to join the Day-One Lab Readiness program.”  

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 net revenues of more than $11 billion for 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 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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share 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; 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 diagnostic solutions, the impact of various factors on operating and financial results, and the opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions 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, other adverse actions of governmental and third-party payers, changes in testing guidelines or recommendations, adverse results in material litigation matters, the impact of changes in tax laws and regulations, failure to maintain or develop customer relationships, our ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, employee relations, and the effect of exchange rate fluctuations. Actual results could differ materially from those suggested by these forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s Form 10-K for the year ended Dec. 31, 2018, and subsequent Forms 10-Q, including in each case under the heading risk factors, and in the Company’s other filings with the SEC. The information in this press release should be read in conjunction with a review of the Company’s filings with the SEC including the information in the Company’s Form 10-K for the year ended Dec. 31, 2018, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.