Companion Diagnostic Partnership

Companion Diagnostics
Programs for Pharma Partners
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QIAGEN is the global leader in partnering with the pharmaceutical industry to provide programs for companion diagnostic development and global commercialization.

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.

The healthcare industry understands the wider benefits of a companion diagnostic in delivering reduced healthcare costs and improved patient outcomes. A companion diagnostic can assist in achieving drug approval, which may otherwise have been withheld, and may provide a competitive advantage through increased drug efficacy within a focused market, with the resulting elevation in drug sales.

QIAGEN works in 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.

Co-development
Regulatory expertise
QIAGEN’s complete systems approach
Drug–Diagnostic commercialization strategies
QIAGEN’s leadership and experience
Additional information
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 pharmaceutical companies.

Benefits of partnering with QIAGEN for companion diagnostic co-development:
  • Proven global regulatory experience 
  • Complete in vitro diagnostic (IVD) menu and operations 
  • Global diagnostic commercialization 
  • Experience in companion diagnostic co-development 

Every companion diagnostic co-development project has its own, dedicated Project Team, comprising QIAGEN professionals from R&D, Product Development, Quality, Regulatory Affairs, and Program Management.

Timing is crucial to maximize success in drug–diagnostic development. Risk of failure is minimized through beginning the process early, preferably during the preclinical phase or Phase I of clinical development. FDA approval in particular requires prospective clinical data. Therefore, access to an appropriate diagnostic before beginning clinical trials can be imperative. Consider the goal and the companion diagnostic development workflow necessary to achieve it.


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Back to top 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. Key points that we consider:

Most companion diagnostics take the premarket approval (PMA) route through the FDA, which comprises various submission modules, including:
  • Analytical validation module
  • Manufacturing module
  • Clinical module
Most companion diagnostics are considered a high-risk device (Class III), based on risk/benefit to patient
  • Clinical utility must be proven in a prospective, hypothesis-driven clinical trial that includes both drug and diagnostic (typically a pivotal/Phase III trial)
The FDA views a companion diagnostic as an in vitro, diagnostic medical device
  • In many cases, the PMA process reviews the entire medical device — so not just the assay, but the pre-analytical sample preparation chemistry, the instrument, and the software as a complete package
  • For commercial purposes, the manufacturer must have the rights to and control of all components of the medical device to ensure that the approved product does not alter in composition without prior notice and regulatory compliance

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Back to top QIAGEN’s complete systems approach

QIAGEN is well positioned to offer a complete package for all aspects of companion diagnostic co-development, including a broad range of molecular diagnostic chemistry and technology platforms.

QIAGEN provides tools to identify suitable biomarkers during Phase I and II on preclinical and clinical samples.

Sample and assay technologies:
  • Assay design, development, and manufacture
  • Range of pre-analytical products and platforms
  • Investigational Use Only kits to support clinical trials during client collaborations
  • Biomarker and genetic content IP
Our PCR and sequencing-based technology platforms enable companion diagnostics to be developed for:
  • SNP detection and mutation profiling
  • Copy-number analysis
  • Gene expression analysis — RNA and miRNA signatures
  • Epigenetic profiling

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.

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.


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Back to top 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.

Commercial partnership and co-promotion initiatives are available, both pre and post launch:

Diagnostic support
  • Training to help you stay operational
  • Expert scientific advice — 24 hours a day
  • Onsite technical services — available when you need them
  • Ordering service
  • Reimbursement support team
Engagement
  • Scientific advisory board and KOL management
  • Medical education and communication
  • Patient advocacy
Joint promotion activities
  • Advertising, media outreach, symposia

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Back to topQIAGEN’s 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
  • Technology platforms that enable access to content from any biological sample, covering all steps from sample preparation to the final test result
Registration
  • Professionals experienced in PMA, CE mark, and other non-US regulatory submissions
Co-marketing
  • Medical education and advocacy development programs, as exemplified by our HPV testing portfolio
  • Global sales, marketing, and distribution network of 1500 professionals (500 molecular diagnostic specialists)
  • Consultancy and lobbyist for reimbursement support

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.

See our pages on the QIAGEN therascreen range of companion diagnostics (not available in all countries).

Read our Press Releases on the latest companion diagnostic agreements.


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Information resource

QIAGEN regularly exhibit and present at events. Review our upcoming attendance at events.


Resources

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Additional Resources
1
Presentation by Richard Watts, Senior Director of Pharma Business Development at QIAGEN (PDF).
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External Links
8
The Personalized Medicine Coalition (PMC) promotes new ways of thinking about heathcare.
Audio recording and transcript of discussion on personalized medicine.
American Society of Clinical Oncology Provisional Clinical Opinion (2009).
Factors to consider when making benefit-risk determinations in medical device premarket review.
Guidance for industry and Food and Drug Administration staff.
Comprehensive information for patients, caregivers, and their families in the USA.
Report from "Health Advances" (2010) written with support from the Biotechnology Industry Organization (PDF).
Summary (2010) of discussions by the PMC Medicare Reimbursement Workgroup (PDF).