SC29: How Molecular Multiplex Testing for Infectious Disease Is Shaping Up

TUESDAY, MARCH 3 | 6:30 - 9:30 PM (DINNER PROVIDED)

ABOUT THIS COURSE:

The use of multiplex commercial molecular assays that simultaneously detect and identify multiple pathogens associated with clinical syndromes is revolutionary, enabling health care providers to rapidly diagnose certain infections and therefore allowing clinical management decisions (e.g., hospital admission, isolation, and antimicrobial treatment or lack thereof) to be made in a timely manner. The first FDA-approved multiplex PCR panel for a large number of pathogens was introduced in 2008 for upper respiratory tract infections. Since then, 19 companies have introduced a total of 35 FDA-cleared panels, plus 32 more with CE-IVD approval, for detection of respiratory, gastrointestinal, central nervous system, vaginal and bloodstream pathogens. This course will review the development and direction of this market by syndrome and segment and also look at the pre- and post-market regulatory challenges in the introduction of new tests.

TOPICS TO BE COVERED:

• The overall environment and competitive landscape
• Current market adoption and segmentation by syndrome, multiplexing capabilities, test throughput and turnaround time
• Panel pricing and reimbursement
• Review of new opportunities
• Regulatory approval and post-market challenges

COURSE AGENDA:

6:30 pm Dinner Buffet

7:00 Course Introduction

7:10 Market Environment and Competitive Landscape

Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting

7:45 Competitive Review and Segmentation of the Current Multiplex Panel Market

Lawrence J. Worden, Founder, Principal, IVD Logix

8:15 Session Break

8:30 Pre-Market Regulatory Concerns and Post-Market Requirements for Multiplex Test Development

Joen Johansen, President, MDC Associates, Inc.

9:05 Q&A with Attendees/Speakers

9:30 Course Ends

INSTRUCTORS:

Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting

Lucy has been consulting to IVD test manufacturers since 2015 supporting more than 20 companies and providing a deep understanding of the road to market for IVD tests from product concept to launch. She also works for various organizations in the global public health sector where the emphasis is on building access to diagnostics in low- and middle-income countries (LMICs). She has 30 years of experience commercializing products in the Life Science Research and Diagnostics industries, with much of that time in molecular diagnostics. She managed sales and marketing teams for Roche Molecular Diagnostics in South Africa and Canada and has led marketing teams with global responsibility for various companies including Roche Molecular Diagnostics and Gen-Probe (now Hologic) for more than 10 years. She holds a Bachelor of Science Honours degree in Medical Biochemistry from the University of Cape Town Medical School, and an MBA from IMD in Switzerland.

Joen T. Johansen, President, MDC Associates, Inc.

Joen is President of MDC Associates, Inc. a full-service RA/QA/CRO servicing diagnostic companies. Joen has more than 17 years of marketing, sales, business development and management experience in the IVD industry. Prior to MDC he was Head of Global Marketing for Accelerate Diagnostics, Inc. where he was responsible for the global launch of the Accelerate Pheno™ system. The system is the first rapid AST platform and was approved for use in the US via the FDA de novo process. Joen has helped to define, develop and commercially launch more than 16 FDA-cleared, CE-marked IVD products in the United States and Europe. Prior to joining the IVD industry Joen was a Healthcare Investment Banker with Lehman Brothers in London. Joen has degrees in Molecular Biology & Biochemistry and Economics from Wesleyan University.

Lawrence J. Worden, Founder, Principal, IVD Logix

Larry is the Principal of IVD Logix, a full-service marketing research and consulting business for in vitro diagnostics he founded in 2017. Larry also co-founded and retains and ownership interest in Market Diagnostics International, where he was instrumental in developing the IVD Insights and IVD LabFile syndicated databases on in vitro diagnostic testing. He was also a senior consultant and co-founder at CaseBauer & Associates, an international business development and research firm exclusively focused on in vitro diagnostics and has held senior legislative/regulatory affairs and market research positions with Becton Dickinson and Company, AdvaMed and IMS Health (now IQVia). He has authored numerous regulatory compliance manuals for the diagnostic and medical device industries and is the most recent Past-President of the Diagnostics Marketing Association. He has a Master’s degree in Public Administration from the University of Maine.

Back to Short Courses