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






Burke_TaraTara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)






Lasiter_LauraLaura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research

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

Stenzel_TimTim 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

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

DTC/“Over the Counter” genetic tests that are initiated by consumers/patients rather than clinical physicians, are the most disruptive health technology of this decade. Combining clinical laboratory sequencing diagnostics with highly innovative digital health information systems, digital health/artificial intelligence (AI) companies and clinical laboratories need to understand FDA regulatory requirements and dynamic compliance risk to develop and implement effective commercialization strategies.  Following the landmark FDA’s first-of-a-kind authorization of 23andMe’s DTC pharmacogenetic test system, establishing the federal regulatory framework for marketing “clinical grade” in vitro diagnostic genetic test kits marketed directly to consumers/patients, FDA stepped up its enforcement activity against clinical laboratories and digital health companies with safety alerts warning physicians and patients about patient initiated genetic tests that have not undergone FDA review.  In an April 2019 Warning Letter to Inova Genomics Laboratory, FDA declared that certain LDTs ordered by the company/laboratory physicians “pose significant risks to patient safety.” In that strongly worded letter, FDA further emphasized that, to protect public health, it can and will take enforcement action against LDTs for failing to comply with “premarket review and other FDA legal requirements that do apply to LDTs.”  As 23andMe’s external FDA regulatory counsel and nationally recognized FDA regulatory advisors for LDTs, digital health/AI, and NGS companion diagnostics, Goldbug Strategies is at the forefront of the evolving FDA regulatory landscape.  Sheila D. Walcoff, former FDA Associate Commissioner and the CEO and Founder of Goldbug Strategies, will discuss the evolving FDA regulatory landscape for commercializing genomic testing and information services.

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

Klein_RogerModerator: 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

Stenzel_TimPanelists: 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

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

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


Paul Gerrard, Chief Medical Officer and MolDX Director of Clinical Science, Palmetto GBA


  • 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

SoftwareCyber_510K 3:40 Is Your IVD Software Prepared for the New IVD Regulations Coming in 2022

Knettell_NancyNancy Knettell, Founder, Principle, SoftwareCyber510K, LLC

In vitro diagnostic (IVD) medical device Software, whether standalone or on a device, will now face a higher level of Regulatory Compliance based on the new IVD Regulations (IVDR) coming in May 2022. Any IVD Companies interested in commercializing their IVD Software will also now require FDA 510K Clearance to be able to sell their products. Learn what is required to successfully support the IVDR standard/510k regulatory requirements by ensuring IEC62304 Compliance with software.


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

Krieger_JoshuaJoshua 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

Hiatt_MarkMark 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

IVD Regulatory Paths: What is FDA Looking for?

Moderator: Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.

  • De Novo submissions: timing and benefit/risk
  • Companion Diagnostics: broad claims IHC, ISH, Digital Pathology: study designs
  • Next-Gen Testing: intended use claims
  • CLIA Waiver & Point of Care Devices

Changing Oncology Workflows to Adopt New Technologies

Moderator: Bill Getty, Vice President, Marketing, Guardant Health

  • ASCO, CAP, and NCCN guidelines and recommendations
  • Physician education and peer influence
  • Pathways and EMR integration
  • Nurse and nurse-navigator education


8:25 Chairperson’s Remarks

Larry K. Wray, PhD, Wray IVD Consulting

8:30 Bringing Single-Cell Genomics to the Clinic

Silver_charlieCharlie 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.

8:50 Real-time in vitro Diagnostic Results at the Point-of-Care

Cary_GunnCary 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.

9:10 Commercializing Guardant360, The Industry Leading Liquid Biopsy

Bill Getty, VP of Marketing, 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.

9:30 Sponsored Presentation (Opportunity Available)

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

11:00 The Development and Commercialization of Companion Diagnostic (Cdx) Tests for Targeted Oncology and Immuno-Oncology Therapeutics

Lucas_DennisLucas 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.

11:20 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?

11:50 PANEL DISCUSSION: From the Lab to the Market- Translating Early Stage Innovation and Successful Partnership Strategies

Moderator: Albine Martin, PhD, Executive in Residence, Johns Hopkin University

Panelists: Henry Ahn, Program Director, SBIR/STTR, Industrial Innovation and Partnerships, Directorate for Engineering, National Science Foundation (NSF)

Yukari C. Manabe, MD, Professor of Medicine, Infectious Diseases, Medicine, Johns Hopkins University School of Medicine


  • Key considerations for developing an early translational roadmap and Angel Investment criteria
  • Funding opportunities and business plan requirements
  • Attracting early strategic partners

12:35 pm Sponsored Presentation (Opportunity Available)

1:05 Luncheon Presentation: Faster Together: Avoid Development Roadblocks by Partnering Early with MilliporeSigma  

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

Explore how we connect researchers with MilliporeSigma experts to exchange challenges/perspectives on IVD development.  With more understanding of customer pain points, our R&D teams can offer customized solutions for the IVD industry's specific needs and accelerate the path to commercialization.

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_SbordoneAlexander 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

Carrascoso_aldoAldo 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.


3:20 PANEL DISCUSSION: Commercialization and Validation of NGS Diagnostics

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

Chiu_CharlesPanelists: Charles Chiu, MD, PhD, 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

Kimberly Hanson, MD, MHS, Director, Transplant Infectious Diseases and Immunocompromised Host Service, Director, Medical Microbiology Fellowship Program, Section Head, Clinical Microbiology, University of Utah, ARUP Laboratories

  • FDA submission guidelines and submission strategies
  • Comparative methods
  • Lab validation vs point-of-care
  • Strategies around regulation and commercialization

4:20 End of Summit

* The program is subject to change without notice, due to unforeseen reason.