Tuesday, October 25, 2016

FOCR Hill Hearing FDA IVD LDT October 13, 2016

http://www.focr.org/events/friends-cancer-research-senate-briefing-future-precision-medicine-patient-care

Friends of Cancer Research Senate Briefing: The Future of Precision Medicine & Patient Care

Senate Briefing

The Future of Precision Medicine & Patient Care:

Current Landscape in Genomic Testing

Thursday, October 13th, 2016 - 12:00pm-1:00pm

430 Dirksen Senate Office Building

Washington, DC

Panelists:

Jonathan Leff, Chairman, Deerfield Institute

Mike Pellini, Chief Executive Officer, Foundation Medicine

Jeff Allen, President and CEO, Friends of Cancer Research

Andrea Ferris, President and Chairman, LUNGevity

John Iafrate, Associate in Pathology, Massachusetts General Hospital

Jeff Shuren, Director, Center for Devices and Radiological Health, FDA

About the issue: Recent years have seen a proliferation in genomic testing options in oncology as more and more treatments are developed to target genetic alterations only present in subsets of the overall population.

Additionally, advances in genomic medicine are taking place within a complex regulatory environment, with oversight split between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

In order to promote progress in genomic testing in the field of oncology, this discussion will address:

The current regulatory landscape for genomic tests
Trends in the use of genomic tests in clinical practice
Strategies to enhance patient safety and access to innovative, high quality tests
Development of new technologies to advance precision medicine

Friends, in partnership with The Deerfield Institute, recently released the results of a comprehensive medical chart audit, which elucidated the trends of genomic testing in oncology. These results were published in the September issue of Personalized Medicine in Oncology, entitled "Use of FDA-Approved and Laboratory-Developed Tests in Advanced Non-Small Cell Lung Cancer: Results of a Retrospective Market Analysis."

Jeff Allen, Friends' President and CEO, also recently testified at the Senate Health, Education, Labor, and Pensions Committee hearing titled, "Laboratory Testing in the Era of Precision Medicine." His full testimony can be read by clicking HERE.