Commercialization of Molecular Diagnostics

Launching molecular diagnostics in the marketplace involves expertise in demonstrating the value proposition of the test, while carefully managing resources and navigating a competitive environment. Rising healthcare costs have led to innovative solutions which include molecular testing matched with targeted therapies, point-of-care testing to provide rapid results for improved patient outcomes, and non-invasive testing options. Attendees can plan to participate in the discussion with expert faculty in the field as they share insights and best practices for handling regulatory approval, reimbursement and clinical adoption to achieve commercial success.

Scientific Advisory Board
Andrew C. Fish, J.D., Executive Director, AdvaMedDx
Harry Glorikian, Healthcare Consultant
John W. Hanna, MBA, Vice President, Endocrinology, Veracyte
Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates
John Beeler, Ph.D., Vice President, Business Development, Inivata


SC4: Overcoming Challenges to Commercial Success in Molecular Diagnostics

SC5: Establishing the Value of Diagnostic Tests

*Separate registration required


10:30 am Registration

11:15 PLENARY KEYNOTE SESSION: Click here for details  

12:50 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:25 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing


1:50 Chairperson’s Opening Remarks

Bruce Quinn, M.D., Ph.D., Principal, Bruce Quinn Associates

2:00 Clinical Laboratory Payment Reform: Implementing Provisions of the Protecting Access to Medicare Act

Carol_BlackfordCarol W. Blackford, Acting Director, Hospital and Ambulatory Policy Group, Centers for Medicare & Medicaid Services (CMS)

This session will discuss Medicare reform of the Clinical Laboratory Fee Schedule based on private payer prices. Topics will also include Medicare payment for advanced diagnostic laboratory tests, coding and pricing for new clinical diagnostic laboratory tests and more.


2:10 PAMA Implementation: Coding, Pricing, and Coverage

Sylvia J. Trujillo, Senior Washington Counsel, American Medical Association (AMA)

An overview of the Medicare Clinical Laboratory Fee Schedule provisions of the Preserving Access to Medicare Act of 2014 (PAMA) concerning coding, data collection and pricing, and coverage provisions. The foregoing will include highlights of coding issues raised by stakeholders, data collection challenges for clinical laboratories (particularly for physician office based laboratories), and possible coverage implications.

2:20 PAMA Final Rule: Key Issues for Advanced Diagnostic Laboratory Tests (ADLTs)

Brian_CareyBrian P. Carey, Partner, Foley Hoag LLP

An overview of the key provisions in the Medicare Clinical Diagnostic Laboratory Tests Payment System Rulemaking regarding coding, data collection and reporting, rate-setting and coverage for Advanced Diagnostic Laboratory Tests (ADLTs). In particular, the presentation will address time line for PAMA implementation, including payment for New ADLTs at Actual List Charge and annual data collection and reporting.

2:30 PAMA Reimbursement: Lessons from Pharma ASP Reporting

Rick_ZimmererRick Zimmerer, Partner, Life Sciences Advisory Services, KPMG LLP

PAMA’s price reporting and reimbursement system for laboratories was modeled on the ASP system that has applied to Medicare Part B drug reimbursement for over a decade. The laboratory industry has the opportunity to avoid mistakes and apply lessons learned from that program. This session will summarize key similarities and differences and explore key areas where lessons may be applicable.



3:30 Value Capture Pathways for Advanced Diagnostic Tests

Charles Mathews, Vice President, Boston Healthcare

How can diagnostic innovators achieve reimbursement success in today’s challenge payer environment? Key factors such as clinical positioning, payer value proposition analysis, and clinical utility evidence development approaches, will be highlighted. This presentation will provide insights into how reimbursement planning can be incorporated into test menu and portfolio development to achieve routine optimal payment regardless of the changing coding and payment landscape.

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

4:45 KEYNOTE PRESENTATION: From Volume to Value in Healthcare: A New Business Model for Diagnostics?

Glenn_SteeleGlenn D. Steele, Jr., M.D., Ph.D., Chairman of the Board, xG Health Solutions, Inc.

A combination of transformative changes in how health care is delivered and paid for will impact the business models of all stakeholders including device manufacturers and molecular diagnostic companies. As value of care to patients is emphasized, and as more targeted diagnosis and therapy become the norm, where care is given, who gives care, who makes product buy decisions, and how the product’s cost benefit is evaluated will all change.


5:15 Moderator's Remarks:

Harry Glorikian, Healthcare Consultant

  • Is bigger better or should panels be more focused?
  • How do you differentiate your institution and its treatment approach from others utilizing genomics?
  • How is the data being used by the physician and its effect on the patient?
  • How does the number of genes affect reimbursement?

Panelists: Mark D. Myslinski, Chief Commercial Officer, Kew Group

Mark S. Boguski, M.D., Ph.D., Founder & CMO, Precision Medicine Network, Inc.

Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center

Jerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine

6:15 Close of Day

6:00 Dinner Short Course Registration


SC11: Regulatory and Reimbursement Issues with NGS and Multiplex Assays

*Separate registration required


7:30 am Problem-Solving Breakout Discussions with Continental Breakfast

Recent FDA Feedback, Tips and Trends for IVDs

Gail Radcliffe, President, Consulting, Radcliffe Consulting, Inc.


  • RTA Checklist: tips for jumping over the first hurdle
  • Next-Gen Testing: regulation snafu
  • CLIA Waiver: simple and low risk of erroneous result
  • De Novo: providing rationale to support De Novo classification


Coverage and Billing and Reimbursement, Oh My! How to Survive Payers’ Policy Review and Payment Processes

Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, eviCore healthcare

This discussion will help participants to:

  • Understand how medical policy committees evaluate clinical evidence
  • Recognize what payers look for in a clinical utility study
  • Determine how to select the right CPT coding strategy
  • Realize why payers review claims data and how this can impact reimbursement


Becoming Agile for IVD Product Development

Ludovic Labat, Ph.D., Global Vice President, Diagnostics, Invetech

  • Why implement agile principles for instrument development?
  • How do I get started?
  • What are lessons learned and pitfalls to avoid?



How LDT Labs and Manufacturers are Being Impacted by Payor Consolidation, ACO Arrangements, and Managed Lab Benefit Programs

8:25 Moderator’s Opening Remarks

John_HannaJohn Hanna, Vice President, Endocrinology, Veracyte, Inc.

The laboratory market is facing a changing payor landscape including consolidation among private payers and Medicare MAC contractors, a greater push for ACO arrangements and P4P incentive programs, and the introduction of laboratory benefit management programs to control molecular diagnostics spend and utilization. Experts in this session will discuss the challenges these dynamics present to labs and manufacturers in participating in payer networks, launching new products, and demonstrating cost-effectiveness as a diagnostic test provider.

8:30 Showing the Value of Diagnostics in ACOs and Risk-Based Payment Models

Chandra N. Branham, J.D., Vice President, Payment & Health Care Delivery Policy, The Advanced Medical Technology Association (AdvaMed)

This talk will review changing pressures on diagnostic manufacturers and labs to show value and evidence to support their test and highlight industry activities to meet these demands head-on by creating a value framework for diagnostics.

8:45 Lab Benefit Management Programs: Can’t Live without Them, but Can We Live with Them?

Lon_CastleLon Castle, M.D., Chief Medical Officer, Molecular Genetics and Personalized Medicine, eviCore healthcare

Securing payment for your diagnostic test used to be simple. You negotiated a contract, you billed for the test and you got paid. Not anymore. Now there are third-party benefit management companies monitoring your billing and coding to determine not only whether or not to pay you, but how much you will be reimbursed. It’s a new world out there, and you need to be prepared. This presentation will cover: Observations on what works—and what doesn’t, billing using molecular diagnostic codes, and what types of billing practices will get your claim stopped in its tracks.

9:00 Demonstrating Utility Evidence - Increasing Requirements for Reimbursement

Joseph_SingerJoseph Singer,M.D., Chief Medical Officer, HealthCore, Inc.

9:15 Q&A with Speakers

Diaceutics Group9:30 Commercialization of Targeted Therapies Outside of Oncology

Steve Vitale, Managing Director, Diaceutics AIS, Diaceutics Group

With the majority of targeted therapy launches in the marketplace focused on oncology, we hear similar challenges around tumor sample logistics, testing algorithms, and report interpretation, but what's happening outside of oncology? Are we seeing similar trends? And what learnings should we take away to help with targeted launches outside of oncology?

9:45 Collaborations by Design - Manufacturing Frontier for Smart Polymer Parts

Christoph_MauracherChristoph Mauracher, Ph.D., Managing Director, STRATEC Consumables GmbH

Let's discuss collaborations between companies, external vendors, research institutions and/or other external partners as of your success. Especially for products in development which are close to a forseeable market introduction experienced partners are able to accelerate the development and support your Life Sciences & IVD business.

Celsee Diagnostics10:00 Coffee Break in the Exhibit Hall with Poster Viewing



10:50 Moderator's Remarks: Andrew C. Fish, J.D., Executive Director, AdvaMedDx

11:00 Regulatory Perspective

Elizabeth_MansfieldElizabeth A. Mansfield, Ph.D., Director, Personalized Medicine, Office of In Vitro Diagnostics & Radiological Health, FDA CDRH

11:15 What is the Evidence Doctors Want to See?

Luis_DiazLuis A. Diaz, M.D., Associate Professor, Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

11:30 Engaging with Payers to Impact Coverage Decisions: Lessons Learned from a Success Story

Williams MarcMarc S. Williams, Ph.D., Director, Genomic Medicine Institute, Geisinger Health System


Interpace Diagnostics12:20 pm The Relevance and Standardization of Clinical Utility

Greg Richard, Senior Vice President, Commercial Services, Interpace Diagnostics

Health plans summarily require Clinical Utility studies before they will consider covering a molecular diagnostic test. The purpose of a Clinical Utility study is to demonstrate that the data from the test being evaluated impacts physicians' treatment of patients. Despite the provision of data from such studies, health plans often do not cover the test. Industry and health plans need to come together to standardize the process and requirements for coverage so it is fair and transparent for all.

12:35 Sponsored Presentation (Opportunity Available)

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Session Break


2:00 Moderator’s Remarks

John Beeler, Ph.D., Vice President, Business Development, Inivata

  • How much content is valuable? How many genes are necessary or ideal in a gene panel? What are oncologists and patients looking for?
  • How are Doctors using data to make decisions?
  • What is the ideal technology to use? Do you need a comprehensive panel upfront?
  • How does cost or regulatory approval factor in?



Regulation: Abraham Tzou, M.D., Medical Officer, FDA

CLIA New York State: Stephanie Shulman, M.P.H., M.S., M.T. (ASCP), Director, Clinical Laboratory Evaluation Program, Wadsworth Center, New York State Department of Health


Policy: Donna A. Messner, Ph.D., Senior Vice President, Center for Medical Technology Policy

Oncologist: Liquid Biopsy: Use in Clinical Trials

Barbara_ConleyBarbara A. Conley, M.D., Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

Liquid biopsies offer the promise of interrogating a patient’s cancer without a biopsy, as well as being able to longitudinally sample the molecular profile. Potential uses for “liquid biopsy” in clinical trials include initial diagnosis, target-finding (predictive marker), pharmacodynamics assays and ascertaining development of resistance. Qualities of a fit for purpose liquid biopsy for use in clinical trials for cancer drug development will be presented.

Girish Putcha, M.D., Ph.D., Director, Laboratory Science, Palmetto GBA (MolDX)

Eli_CasdinEli Casdin, Managing Member, Casdin Capital

4:05 Close of Conference