Cambridge Healthtech’s 9th Annual

Commercialization of Diagnostic Tests

Current Landscape and Successful Strategies

August 21-22, 2019


Disruptive diagnostic tests are a critical part of the rapidly evolving health technology landscape. However, disruptive technologies are only disruptive when they become available. To do that, many traditional clinical laboratories and early stage startup companies have entered the race of commercializing their products and struggle to evaluate the market and its offerings to come up with the strong market entry strategies that will optimize their business success. Cambridge Healthtech Institute’s Ninth Annual Commercialization of Diagnostic Tests conference will convene key opinion leaders in product commercialization, discuss the current landscape and opportunities in diagnostic tests in addition to showcasing examples of those who have made their successful product launches.

Final Agenda


10:30 am Registration

11:30 Plenary Keynote Session

11:30 Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners






11:40 Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Tim Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)

Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition






  • How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
  • How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
  • How are policymakers addressing the role of CMS and CLIA in the VALID Act?
  • How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
  • What impact will changes in diagnostics regulation and oversight have on patient care?


Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)






Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings






Susan Van Meter, Executive Director, AdvaMedDx






1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:35 Ice Cream & Cookie Break in the Exhibit Hall with Poster Viewing


2:05 Chairperson’s Opening Remarks

Roger D. Klein, MD, JD, Faculty Fellow, Center for Law Science and Innovation, Sandra Day O’ Connor Law School, Arizona State University; Expert, FDA & Health Working Group Federalist Society Regulatory Transparency Project

2:10 KEYNOTE PRESENTATION: Latest Updates on Regulation for Dx Testing from a Regulatory Perspective

Tim Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

I will provide the latest updates on current guidelines and recommendations for obtaining FDA approvals for diagnostic tests along with other initiatives at the FDA.

2:40 DTC/Patient Initiated Genetic Testing – Regulatory Landscape

Sheila D. Walcoff, J.D., CEO, Founder, Goldbug Strategies LLC

In the emerging area of DTC/patient initiated genetic testing, Goldbug Strategies has been the external FDA regulatory counsel for 23andMe since January 2014, when the company’s founder asked Sheila to lead its regulatory compliance, FDA interactions, risk mitigation, and pre-market submission work. Goldbug Strategies helped 23andMe design, develop and implement a highly successful approach to positive FDA interactions, compliance strategies, and numerous successful de novo submissions. The “first-of-a-kind” device authorizations granted by FDA as a result of these efforts have helped return 23andMe to its market leadership position as the only DTC/patient initiated genetic testing service authorized by the FDA.

3:10 PANEL DISCUSSION: Regulation and Policy for Diagnostic Tests – Enhancing or Restricting the Innovation and Progress In Diagnostics?

Moderator: Roger D. Klein, MD, JD, Faculty Fellow, Center for Law Science and Innovation, Sandra Day O’ Connor Law School, Arizona State University; Expert, FDA & Health Working Group Federalist Society Regulatory Transparency Project

Panelists: Tim Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Eric Konnick, MD, MS, Assistant Professor; Associate Director, Genetics and Solid Tumors Laboratory, University of Washington

Brad Spring, VP, Regulatory Affairs & Diagnostic Systems, BD Diagnostics

Additional Panelists to be Announced

  • Differences between in vitro diagnostic test kits and laboratory developed tests and the needs of their respective customers
  • Current legislative proposals that would revamp FDA’s current regulatory paradigm for regulation of in vitro diagnostic tests
  • Potential ways to modernize to CLIA to meet perceived regulatory gaps
  • FDA approaches in the face of Trump-era regulatory philosophy
  • The role of Medicare and its contractors as regulators through payment pathways and processes
  • Regulatory approaches to test regulation in Europe

3:40 Sponsored Presentation (Opportunity Available)

4:10 Refreshment Break in the Exhibit Hall with Poster Viewing


4:55 Chairperson’s Remarks

Roger D. Klein, MD, JD, Yale University; Principal, Consulting and Klein & Klein Co.


5:00 Genomic Health: Launching a Paradigm Shift ... and an Innovative New Test

Joshua Krieger,  PhD, Assistant Professor, Entrepreneurial Management Unit, Harvard Business School

A business case study on “Genomic Health” will be presented. This case explores the decisions the Genomic Health team had to make in defining the marketing plan, pricing, and reimbursement strategies that would give it the greatest chance of success in bringing its new product to market. This is an interactive session and the case material will be provided beforehand with a question list to be discussed during this session.

Learning Objective

To introduce market dynamics within the diagnostics segment of the medical devices industry, including issues related to traditional and emerging diagnostics business models, product development, government regulation and reimbursement; to understand of how advancements in genomics impact the traditional diagnostics market and their potential effects on payers, patients, physicians, and the larger health care system; and to introduce the constraints, opportunities, and trade-offs associated with launching an innovative product that also represents a paradigm shift within the traditional diagnostics industry.

Questions to be Discussed

1. How does Oncotype DX create value?
2. What determines the price that Genomic Health can charge for the diagnostic? Who influences the pricing decision? Ultimately, what should they charge?


6:30 Close of Day

6:30 Dinner Short Course Registration

6:45 - 9:15 pm Recommended dinner Short Course*

SC14: Generating Evidence and Creating a Winning Dossier for Regulatory and Reimbursement Needs

Mark Hiatt, MD, Vice President, Guardant Health

John Sninsky, PhD, Consultant, Translational Sciences

Managing the clinical narrative for your diagnostic test requires careful evaluation of the evidentiary requirements of stakeholders. Using those evidentiary requirements to determine your clinical and economic study designs is the cornerstone of effective product development.

*Separate registration required .


7:15 am Registration

7:30 Problem Solving Breakout Discussions with Continental Breakfast


8:25 Chairperson’s Remarks

Larry K. Wray, PhD, Wray IVD Consulting

8:30 Bringing Single-Cell Genomics to the Clinic

Charlie Silver, Co-Founder, CEO, Mission Bio

Mission Bio provides targeted single-cell DNA solutions for high-impact applications, including oncology and CRISPR validation. Our technology helps cancer centers and drug companies identify every diseased cell so they can deliver durable treatments. Our journey from university spin-out through launch and scale-up will be discussed.

9:00 Real-time in vitro Diagnostic Results at the Point-of-Care

Cary Gunn, PhD, Founder, CEO, Genalyte

The Maverick Detection System performs real-time detection of macromolecules in crude samples using biologically functionalized silicon photonic biosensors lithographically printed on disposable silicon chips. Test results are available in 10-30 minutes depending on the type of assay performed. Our story of how we get to where we are will be discussed.

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Chairperson’s Remarks

Larry K. Wray, PhD, Wray IVD Consulting

11:05 Commercializing Guardant360, The Industry Leading Liquid Biopsy

Mark Jacobstein, Chief User Engagement Officer, Guardant Health

Commercializing a complex diagnostic while developing a new market requires a multi-pronged and multi-year approach. Changing MD behavior requires clinical utility data, KOL endorsement, clinical guideline support, clarity around patient financial burden and reimbursement, a product that fits into practice, as well as traditional field force pull through. There are no shortcuts.

11:35 The Development and Commercialization of Companion Diagnostic (Cdx) Tests for Targeted Oncology and Immuno-Oncology Therapeutics

Lucas Dennis, PhD, Director Clinical Product Development, Foundation Medicine Inc.

Through continued innovation, Foundation Medicine is dedicated to improving outcomes for individuals living with cancer. Our approach combines genomic profiling products and data services to generate insights that can help doctors match patients to treatment options, as well as accelerates the development of new therapies. Our story will be discussed.

12:05 pm PANEL DISCUSSION: Product Launch and Market Entry Approaches

Moderator: Larry K. Wray, PhD, Wray IVD Consulting

Panelists: All Speakers in the Session

  • Current stand on bringing your technology to market
  • How to develop your go-to-market strategy?
  • What role did reimbursement play in your strategy and how did you address that?
  • What were/are the major challenges incorporating your technology into healthcare and how did or are you addressing those? Are you planning on having your products incorporated into guidelines?
  • How are regulatory requirements addressed as part of the marketing plan?
  • What role are KOLs and/or institutions playing as you bring your technology to market?

12:35 Sponsored Presentation (Opportunity Available)

1:05 Luncheon Presentation: Fast Track to Assay Development and Commercialization: Partner with MilliporeSigma

Savita Bagga, PhD, MBA, Global Strategic Program Marketing Manager, Diagnostics, MilliporeSigma

As IVD solutions move from the world of RUO to clinical relevance the requirements on raw materials changes. Explore how partnering with suppliers early in IVD development can help minimize challenges and accelerate the pipeline to commercialization. The current strategy at MilliporeSigma is focused on creating enabling channels for interaction between R&D groups in the IVD manufacturing sector with our internal R&D teams. Greater interactions between the two teams will provide more understanding and clarity of your specific needs. Working in collaboration our R&D teams will be able to offer solutions/reagents that are customized for your specific needs and assays. They will also help to identify any further roadblocks (if any) in your workflows.

1:35 Dessert Break in the Exhibit Hall with Poster Viewing

2:15 Chairperson’s Remarks

Aldo Carrascoso, PhD, CEO, InterVenn

2:20 How Diagnostic Tests are Being Evaluated and Adopted at the Minute Clinic

Alexander Sbordone, JD, OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health

I will discuss the process and cycle that CVS MinuteClinic uses to evaluate new diagnostic tests. Criteria for efficiency, sensitivity, accuracy, robustness and cost will be reviewed.

2:50 Lessons Learned from Raising Capital for Diagnostic Start-Ups

Aldo Carrascoso, PhD, CEO, InterVenn

Venture capitalists have tended to shy away from diagnostics companies, whose products are not predicated on the blockbuster model of pharmaceuticals. However, several new diagnostics companies are developing products that can improve healthcare delivery. It is in the start-ups’ hands to change this mindset and prove its added value to advance the standard of care. Lessons learned from raising capital for Dx start-ups will be discussed.


Moderator: Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA

Panelists: Charles Chiu, MD, PhD, Associate Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine

Additional Panelists to be Announced

  • FDA submission guidelines and strategies
  • Comparative methods
  • Lab validation
  • Commercialization strategies

4:20 End of Summit