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The value of molecular testing is in the prognosis, diagnosis and management of diseases, and managing commercialization of new assays is critical to realizing their potential. Moving a molecular diagnostic test to the market involves navigating the current environment to understand how to approach pricing and reimbursement, tackling analytical validity and clinical utility, and gaining clinical adoption. This year’s faculty will give insight on handling these challenges from their experience in the field and demonstrate how it will lead to commercial success.

Scientific Advisory Board

Harry Glorikian, Healthcare Consultant

Kristin Ciriello Pothier, Partner/Principal, Ernst and Young


Day 1 | Day 2 | Short Courses | Download Brochure 



10:30 am Registration

PLENARY SESSION: Think Tank on Next-Generation Sequencing Diagnostics

11:00 Chairperson’s Opening Remarks

Harry Glorikian, Healthcare Consultant

11:10 Discussion: Regulatory Review of Clinical Sequencing Assays

Harry GlorikianModerator: Harry Glorikian, Healthcare Consultant


Jennifer DickeyGuest Speaker: Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration


In November of 2013, the FDA issued the first clearances of Next Gen Sequencing- (NGS) based assays. There have additionally been a number of clinical trials approved recently that utilize NGS-based assays for patient enrollment or stratification. In light of the expanding roles that new sequencing technologies are playing in clinical decision making, this talk will focus on critical elements that FDA considers when evaluating NGS validation using the recent clearances/approvals as examples. There will also be a discussion of any new communications that FDA has issued in regard to the regulatory review of NGS- based assays. Following the discussion there will be a Q&A with the audience.

11:55 Next-Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement  

Elaine LyonModerator: Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP


Case Presenters:

Andrea Ferreira-Gonzalez Andrea Ferreira-Gonzalez, Ph.D., Professor, Pathology; Director, Molecular Diagnostics Lab, Virginia Commonwealth University


Madhuri HegdeMadhuri Hegde, Ph.D., FACMG, Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine


The landscape of next-generation sequencing diagnostics is changing rapidly. Clinical laboratories are offering highly complex tests using new technologies, but face challenges in reimbursement. To be reimbursed for these tests, laboratories will need to address clinical utility as well as clinical validity. Clinical cases that demonstrate the utility of genomic oncological and inherited disease testing will be presented. Experiences with reimbursement of these tests will be discussed.

12:40 pm Enjoy Lunch on Your Own


Kristin Ciriello Pothier1:50 Moderator: Kristin Ciriello Pothier, Partner/Principal, Ernst and Young

This panel will discuss the challenges of reactive partnering in precision medicine and discuss, with industry leaders who have been both proactive and reactive in this industry, how stakeholders can access the help they need to develop precision medicine programs with the right partners in the right locations at the right time.



Eric LaiEric Lai, Ph.D., Senior Vice President & Head, Pharmacogenomics, Takeda Pharmaceuticals


Glenn MillerGlenn A. Miller, Ph.D., CTO & Executive Vice President, Molecular MD


best practices in commercialization

3:20 Chairperson’s Remarks

Ali Tinazli, Ph.D., Director & Head, Business Development & Sales, Sony DADC BioSciences, Sony DADC

3:30 Understanding the Current Reimbursement Environment and the Impact to Your Bottom Line

Rina WolfRina Wolf, Vice President, Commercialization Strategies, Consulting and Industry Affairs, XIFIN, Inc.

The reimbursement environment is continually changing, often presenting new challenges and hurdles on a frequent basis. This presentation will review the most recent changes from both CMS and the commercial payor perspective. Labs must maintain their awareness of these changes and updates in order  


4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 PANEL DISCUSSION: What’s Ahead? How to Protect Yourself from Commercialization Practices that Put You in Jeopardy of an Audit

Moderator: Rina Wolf, XIFIN, Inc.

With new codes and reimbursement rates in effect, molecular labs are facing an unprecedented convergence of disruptive and potentially game-changing factors. In the current audit heavy environment, laboratories must be certain that their business practices align with relevant laws and guidelines. With these changes, you need to ensure you minimize the risk of having your company audited for non-compliance.


David GeeDavid W. Gee, Partner, Davis Wright Tremaine LLP


Patric HooperPatric Hooper, Founding Partner, Hooper, Lundy & Bookman, PC


6:15 Close of Day

6:00 Dinner Short Course Registration

Recommended Dinner Short Course* 

6:30-8:30 pm Regulatory and Reimbursement Issues with Next-Generation Sequencing and Multiplex Assays

*Separate registration required

Day 1 | Day 2 | Short Courses | Download Brochure 

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2014 Brochure

2014 Brochure 

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