Precision medicine has touched every aspect of healthcare today, and, evident from President Obama's State of the Union speech for 2015, is also on the federal government's radar, with plans to increase funding for basic research by the NIH and regulation by the FDA. However, while diagnostic tests play a critical role as they guide physician decision-making, particularly in oncology, by generating data that are expected to improve patient outcomes, questions remain on the clinical utility of some of these tests as well as the validity of laboratory-developed tests or LDTs. While next-generation sequencing is on the horizon for the FDA's regulatory perview, assessing the validity and utility of existing FDA-approved tests and LDTs and who pays for the tests are important questions that need to be addressed.
The American Journal of Managed Care invited an expert panel to gain a better understanding of the current status of these issues that have plagued the healthcare world for a while. Led by the managing editor of AJMC's Evidence-Based series, Surabhi Dangi-Garimella, PhD, participants in the discussion included 2 payers and 2 providers:
Francisco J. Esteva, MD, PhD, professor of medicine, director of breast medical oncology, and associate director of clinical investigation, Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center; Daniel F. Hayes, MD, division of Hematology/Oncology, department of Internal Medicine, University of Michigan Medical School; John L. Fox, MD, MHA, associate vice president, medical affairs, Priority Health; and Bryan Loy, MD, MBA, vice president oncology, laboratory and personalized medicine, Humana.