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.”
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