Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 3222 DIAGNOSTICSFOR THE RIGHT CARE A D VA M E D D X Kathy Hudson, deputy director for science, outreach and policy at the National Institutes of Health, addresses an AdvaMedDx Capitol Hill briefing on precision medicine, adjacent Andy Fish, executive director of AdvaMedDx. Operating as a division of AdvaMed, AdvaMedDx advocates on behalf of the world’s leading diagnostic manufacturers to promote the value of diagnostic tests for better health and better care. Diagnostics guide the delivery of the right treatment to the right patient at the right time, improving outcomes for people around the world while, in many cases, lowering overall health care costs. In 2015, AdvaMedDx continued proactive initiatives to support diagnostics developers and bring about major payment and policy reforms. These efforts included: •  Working closely with the Centers for Medicare and Medicaid Services (CMS) and other key stakeholders to ensure effective implementation of diagnostics payment reform provisions of the Protecting Access to Medicare Act, including assign- ment of unique identifiers to existing and new tests, and use of temporary codes to expedite coverage decisions and facilitate payment. •  Developing comprehensive policy on reforming diagnostics oversight and working closely with FDA, key congressional committees and other stakeholders to advance reform legislation. AdvaMedDx also supported a number of innovation provisions included in 21st Century Cures legislation in the House. AdvaMedDx continued its high visibility advocacy and public affairs activities in the U.S. and abroad by partnering with stake- holder organizations. In 2015, AdvaMedDx focused on areas of critical importance to patient and public health, including the threat of infectious diseases and antibiotic resistance, as well as developments in precision medicine, in which diagnostics play a cornerstone role in dramatic advances in care and treatment. Specific initiatives included: •  Partnering with the administration on the Combating Antibiotic-Resistant Bacteria initiative, including participating in the White House Forum on Antibiotic Stewardship, to help educate policymakers on the critical role of diagnostics in fighting antibiotic resistance. •  Organizing a diagnostics day at the Centers for Disease Control and Prevention to forecast the future development of diagnostic tests that can contribute to the fight against antibiotic resistance and better understand how to overcome barriers to development and utilization of such tests. •  Partnering with the American Cancer Society Cancer Action Network on a series of roundtables on personalized medicine in Ohio, California, Pennsylvania, North Carolina and Florida. •  Supporting two U.S.-based briefings in partnership with leading cancer organizations focused on precision medicine and how patients, physicians, the diagnostics industry, and others can work together to give health care providers the tools and information they need to make personalized treatment decisions for their patients. •  Conducting the fourth annual diagnostics briefing at the World Health Assembly focused on the role of diagnostics in global infectious disease outbreaks. Arnd Kaldowski, president of Beckman Coulter Diagnostics at Danaher (at right), and John Hertia, Bio-Rad executive vice president and president, clinical diagnostics, participate in an AdvaMedDx Board meeting in San Diego. Vital Insights Transforming Care A D V A M E D 2 0 1 5 A N N U A L R E P O R T