SC1: Trends and Factors Impacting the Genetic Testing Landscape
SUNDAY, MARCH 1 | 2:00 - 5:00 PM
ABOUT THIS COURSE:
There are >75,000 health-related genetic tests on the market, sold by dozens of companies. The testing landscape is shifting with different players, delivery models and markets. The landscape is influenced by regulatory, reimbursement and ethical issues. Learn about the factors impacting this fast-growing market.
COURSE AGENDA:
2:00 pm Part I: Genetic Testing History and Current Landscape
Jeanette McCarthy, MPH, PhD, Adjunct Associate Professor, Duke University; Founder, Precision Medicine Advisors
The genetic testing market has exploded in the past five years with testing available across many clinical specialties including prenatal, pediatric and rare diseases, oncology, cardiology and others. What scientific and technological advances led us here and how has our understanding of the genetic basis of disease changed?
2:45 Part II: Evaluating the Validity and Utility of Genetic Tests
Jeanette McCarthy, MPH, PhD, Adjunct Associate Professor, Duke University; Founder, Precision Medicine Advisors
Evaluating the performance of genetics tests is key to ensuring their safety and efficacy. Healthcare providers deciding which genetic test to order, regulators assessing the safety and efficacy of a test and payors making coverage determinations would all benefit from having a coherent framework for evaluating genetic tests. In this module, we’ll take a closer look at how we measure analytical validity, clinical validity and clinical utility of genetic tests.
3:15 Refreshment Break
3:45 Part III: Regulatory, Reimbursement, Legal and Ethical Issues Impacting Uptake of Genetic Testing
Jeanette McCarthy, MPH, PhD, Adjunct Associate Professor, Duke University; Founder, Precision Medicine Advisors
The FDA has begun regulating pharmacogenomic tests while their overall strategy for regulating laboratory developed tests is in Congress’s hands. Cost and reimbursement remain formidable challenges, along with consumers’ concerns about privacy. On the backdrop of this, healthcare providers are reluctant to order tests, but failure to order a test may expose liability. In this module, we’ll discuss the various factors impacting uptake of genetic testing.
4:00 Part IV: Trends and Evolving Models of Delivery of Genetic Testing
Jeanette McCarthy, MPH, PhD, Adjunct Associate Professor, Duke University; Founder, Precision Medicine Advisors
Health-related genetic tests are generally ordered and delivered through the patient’s healthcare provider, a so-called physician-initiated testing model. Increasingly, patients and consumers are initiating genetic health tests on their own through alternative patient-initiated or direct-to-consumer models. The companies offering genetic testing are experimenting with different models to reach new customers. What are some of the creative models used and what are the implications for moving away from physician-initiated testing?
4:45 Q&A with Attendees/Speakers
5:00 Course Ends
INSTRUCTOR:
Jeanette McCarthy, MPH, PhD, Adjunct Associate Professor, Duke University; Founder, Precision Medicine Advisors
Jeanette McCarthy is a UC Berkeley trained genetic epidemiologist and spent the early part of her career in industry at Millennium Pharmaceuticals before transitioning to academia. She currently holds adjunct faculty positions at Duke University and UCSF. Her previous research had focused on the genetic underpinnings of complex diseases, both infectious and chronic. More recently, she has become a leading educator in the field of genomic and precision medicine involved in demystifying genomics for non-technical audiences, including health care providers, patients and other stakeholders. In 2014 she helped launch the first consumer-facing magazine in this field, Genome, where she served as editor-in-chief until 2016. She teaches genomic and precision medicine through UCSF and UC Berkeley Extension and online through the Precision Medicine Academy (precisionmedicineacademy.org). She also designs and delivers custom workshops and courses to international audiences and advises companies on strategic and technical aspects of precision medicine. Jeanette is coauthor of the book, Precision Medicine: A Guide to Genomics in Clinical Practice (2016, McGraw Hill Education).
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