SC28: Global Companion Diagnostic Commercialization Boot Camp



Successful development and launch of companion diagnostics require careful consideration of an array of success factors. All too often there are difficult transitions between development, regulatory approval, and assay commercialization. In this short course, you will hear about global companion diagnostic commercialization from industry experts with both diagnostic and pharma perspectives. Attendees will learn from the successes and failures of various companion diagnostic launches and will be able to take away best practices that can be aligned to their own projects/programs. The course will conclude with a deep-dive examination of a particularly interesting example, the launch of one of the first next-generation sequencing–based companion diagnostics, the Thermo Fisher’s Oncomine™ Dx Target test.


  • Key differences between pharma and diagnostic business models and approaches to Rx/Dx commercialization
  • A framework for planning for the launch of companion diagnostics
  • Discussion of unique features of different global markets (US, EU, Japan, emerging markets)
  • Assay development/design considerations
  • A brief overview of the changing regulatory environment (IVD, LDT, EUIVDR)
  • Examples of CDx successes and failures
  • NGS global commercialization considerations
  • A review of key stakeholders involved in CDx adoption and thoughts on partnerships approaches
  • Assay deployment/commercialization best practices


6:00 pm Dinner Buffet

6:30 Rx/Dx Global Commercialization Framework

Charles Mathews, Principal, ClearView Healthcare Partners

The session will begin with an overview of some of the key differences between pharma and diagnostics and how these lead to challenges within Rx/Dx partnerships. The instructor will review the key components involved in the successful companion diagnostic commercialization (assay design, laboratory deployment, regulatory approval, reimbursement, infrastructure support, etc.) and highlight some of the key differences in global markets.

7:00 Key Stakeholders in Companion Diagnostics Commercialization and Partnership Considerations

Julie Ramage, Director, Precision Medicine Quality Initiatives and Partnerships, AstraZeneca

The next speaker will review the range of stakeholders involved in companion diagnostic commercialization including well-known entities such as pharma and IVD but also some less frequently discussed players such as guidelines groups, laboratories, payers, quality groups, and patient advocacy. The instructor will provide guidance on do’s and don’ts as it relates to working on issues with these groups based on her experience working both within labs and in pharma.

7:45 Dessert Break

8:00 Case Study: Oncomine™ Dx Target Test

Rob Dumanois, Manager Reimbursement Strategy, Clinical Next-Generation Sequencing Division, Thermo Fisher Scientific

The final session will involve an in-depth examination of the launch of one of the first NGS-based companion diagnostics, the Oncomine™ Dx Target Test. The instructor will provide information into how this launch came about and share insights into the practical challenges associated with successfully launching this test. In particular the unique reimbursement and regulatory pathway the assay took will be explored.

8:30 Q&A with Attendees/Speakers

The course will conclude with a session in which participants describe their interests in companion diagnostics and the course instructors lead a group discussion of commercialization considerations for each situation.

9:30 Course Ends


Mathews_CharlesCharles Mathews, Principal, ClearView Healthcare Partners

Charles is the leader of ClearView’s diagnostics practice. In this role he provides strategic insights into development, commercialization, and reimbursement approaches for a range of in vitro diagnostic platform and kit developers, laboratories, and pharma players launching products with companion diagnostics. These tests range from point-of-care technologies to esoteric molecular and next-generation sequencing approaches. His prior experience includes work within biotech, clinical trials, and on Capitol Hill.

Ramage_JulieJulie Ramage, Director, Precision Medicine Quality Initiatives and Partnerships, AstraZeneca

As Director, Precision Medicine Quality Initiatives and Partnerships at AstraZeneca, Julie is currently working to expanding the company’s relationships with labs and professional organizations. She previously provided subject matter expertise to Pfizer’s growing portfolio of therapies with companion diagnostic activities. Julie has an expansive background in pathology, laboratory technologies, platforms, reimbursement and regulatory matters. Prior to joining pharma, she worked with large commercial references labs in sales management roles.

Dumanois_RobertRob Dumanois, Manager Reimbursement Strategy, Clinical Next-Generation Sequencing Division, Thermo Fisher Scientific

Rob leads reimbursement strategy for Thermo Fisher’s Oncomine™ Dx Target Test: the first FDA-approved next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung carcinoma (NSCLC). This companion diagnostic, now covered by Medicare’s NCD and dozens of commercial payers, was developed with Pfizer and Novartis. Prior to joining Thermo Fisher in 2012, Rob played key payer and commercial roles with Navigenics, RelayHealth, and UnitedHealthcare.

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