Partnering for Precision Diagnostics

Programs for Pharma Partners
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QIAGEN is the leading provider in molecular companion diagnostic solutions.

We at QIAGEN address urgent healthcare issues with innovative solutions, offering complete Sample to Insight solutions, with the unique ability to serve labs with our best-in-class molecular diagnostics portfolio, our world-class regulatory team, and our strong pipeline of oncology solutions. We uniquely offer both real-time PCR and next-generation sequencing (NGS)-based companion diagnostic development within a complete Sample to Insight workflow, and deliver critical diagnostic solutions across clinical disease progression. We offer global registration and commercialization, and already serve and support more than 500,000 laboratories in over 35 countries directly, with distributors in over 70 countries.

QIAGEN Partnering for Precision Diagnostics is currently running a number of industry-leading pharma companion diagnostics development programs, under 25 Master Collaboration Agreements with the top pharmaceutical companies in the world. We enable insights along the cancer care continuum, including solutions for lung, breast, colon and hematological cancers. Immuno-oncology (IO) is the fastest-growing area of our collaborations with pharma, and NGS-based workflows for complex gene expression signatures with an IVD path are of highest interest to our pharma partners. QIAGEN is committed to delivering solutions for IO and NGS, and will develop any molecular diagnostic test pharma may need, using our broad scope of best-in-class breadth and depth of technology solutions.

Developing solutions to address the needs of the global clinical NGS IVD market
QIAGEN NGS solutions in clinical labs
NGS companion diagnostic development
Global companion diagnostic commercialization
Developing solutions to address the needs of the global clinical NGS IVD market

QIAGEN has clinical molecular diagnostic workflows implemented in over a thousand molecular pathology labs worldwide. Using our complete NGS solutions we are able to develop molecular diagnostic workflows that can be implemented to fit a variety of companion diagnostic needs. NGS is the molecular diagnostic technology of the future, and more and more clinical labs are already adopting NGS technology. Our NGS solutions consider cost per sample, reimbursement, and profitability as well as throughput and turnaround time. For molecular pathology labs, current NGS solutions do not address all of these requirements for routine clinical testing, and therefore the uptake of NGS IVD solutions has been slow. QIAGEN is dedicated to developing and delivering solutions that will meet the needs of clinical labs, and that will break the barriers of implementing NGS in molecular pathology labs. Our GeneReader NGS solutions will offer labs integrated workflows, which are easy to implement and have scalable batch sizes and continuous loading of multiple flow cells enable labs to adapt and scale while controlling costs across widest range of samples (from just 200 to over 3,000 samples/year). This offers molecular diagnostic laboratories and clinicians faster turnaround times with better cost ratios. These solutions are being developed to address the clinical NGS IVD market in the future.


Back to top QIAGEN NGS solutions in clinical labs

With our new Sample to Insight NGS workflow, QIAGEN now offers NGS for companion diagnostic development that meet the needs of molecular pathology laboratories. We offer the first truly complete NGS workflow, which enables actionable insights, flexibility to fit any lab’s needs, guaranteed results with predictable costs and reliable expertise and service. We enable potential partners to create and operationalize their entire workflow through a single contact, and offer extremely flexible business models to help our partners manage budgets and enable profitability.

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Back to top NGS companion diagnostic development

QIAGEN Partnering for Precision Diagnostics leverages the expertise we have in real-time PCR companion diagnostic solutions for the development of NGS companion diagnostic solutions. We leverage our best in class breadth and depth of technologies (from qPCR to NGS), which allows us to act as true consultants ensuring the best solutions for our partners and to align drug and diagnostic development to achieve simultaneous approval, from assay design to clinical validation. We can even provide pharma global clinical trial sample testing through a strategic partnership which we have in place for using diagnostic assays within global clinical trials. Our premium service and expertise enable our pharma partners to better focus on drug development, and leave the molecular assay development to us.

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Back to top Day-One Matters: Global companion diagnostic commercialization

The implementation of new companion diagnostic (CDx) tests for routine testing can be time-consuming, resulting in significant gaps between new drug availability and patient access to testing. 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. Our Day-One Lab Readiness program includes pre-approval preparation of workflow implementation, training, assay verification, forecasting, medical communication and reimbursement to ensure immediate readiness. As a single CDx partner we provide complete Sample-To-Insight Solutions and support the Day-One lab on all steps of early workflow implementation to get ready for CDx testing upon Day-One of drug launch.



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Companion Diagnostics
Personalized healthcare
A companion diagnostic enables personalized healthcare. It predicts which patients are most likely to benefit from a particular therapy or how a therapy would best be administered to an individual. QIAGEN is the global leader in partnering with the pharmaceutical industry to provide programs for companion diagnostic development and global commercialization.
Companion Diagnostics
QIAGEN for a companion diagnostic
QIAGEN is ideally positioned to provide comprehensive, customized work programs for co-development of individual companion diagnostics. We work in close partnership with drug companies by guiding them through the complexities of a co-development program to achieve their goals. Our programs support drug development from inception, through regulatory approval, to launch and beyond.
Companion Diagnostics
Regulatory expertise
QIAGEN have a wealth of global regulatory expertise, including CE mark, registrations in Japan & Asia and in the USA. The FDA sets the most stringent requirements for regulatory approval of a companion diagnostic. QIAGEN has unsurpassed experience working with the FDA on companion diagnostic approval.


Companion Diagnostics
QIAGEN's complete systems approach
QIAGEN leads the market, having complete capabilities to independently deliver companion diagnostics from a variety of molecular diagnostic technologies and platforms. Partnering QIAGEN reduces dependency on third-party suppliers for conformity and license. A typical QIAGEN co-development plan for FDA approval includes the following elements: assay and software development, validation batches, analytical validation, manufacturing capability, clinical trial with non-validated assay to develop clinical utility data.

Companion Diagnostics
Drug—Diagnostic commercialization strategies
QIAGEN understands that adoption and uptake of a companion diagnostic will enable drug sales. QIAGEN works in partnership with pharmaceutical companies to achieve common commercial goals. As the diagnostic partner, QIAGEN takes ownership in enabling global access and availability of the companion diagnostic test and platform through worldwide sales, marketing, and distribution channels.
Companion Diagnostics
Leadership and experience
QIAGEN’s mission is to enable our partners to achieve outstanding success and breakthroughs that make improvements in life possible. Our commitment to our partners drives our innovation and leadership in offering tailored programs that highlight our strength and expertise in sample and assay technologies, registration, and co-marketing. QIAGEN is co-developing companion diagnostics to support drug sales in partnership with leading pharmaceutical companies such as Boehringer Ingelheim, AstraZeneca, Amgen, BMS/Lilly/Imclone, and Pfizer, among others.