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.
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
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.
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:
- 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
- Scientific advisory board and KOL management
- Medical education and communication
- Patient advocacy
Joint promotion activities
- Advertising, media outreach, symposia
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
- Professionals experienced in PMA, CE mark, and other non-US regulatory submissions
- 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.
QIAGEN regularly exhibit and present at events. Review our upcoming attendance at events.