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 u A D V A M E D D X DIAGNOSING SOLUTIONS Operating as a division of AdvaMed, AdvaMedDx is focused exclusively on issues facing diagnostics manufacturers, advocating on their behalf and promoting the value of diagnostic tests for better health and better care. Diagnos- tics guide 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 2016, AdvaMedDx advocacy was critical to supporting diagnostics developers and working towards major policy reforms. These efforts included: • Continuing work 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 the 21st Century Cures Act, which was signed into law in December. • Working closely with the Centers for Medicare and Medicaid Services (CMS) and other key stakeholders to ensure effective implementation of clinical diagnostic laboratory test payment reforms under the Protecting Access to Medicare Act and a related final rule issued in June. AdvaMedDx continued its advocacy and public affairs activities in the U.S. by partnering with stakeholder organizations and producing new educational materials. In 2016, AdvaMedDx focused on areas of critical importance to patient and public health, including antibiotic resistance and precision medicine. Specific initiatives included: • Partnering with the American Clinical Laboratory Association to host a one-day diagnostic summit at Hologic’s head- quarters in San Diego that featured leaders from the clinical laboratory and diagnostic manufacturing sectors, government and commercial payers, the investor community, and Rep. Scott Peters. • Organizing a Capitol Hill briefing focused on domestic infectious disease and the critical need for diagnostic tests to protect patients and the public. • Partnering for the second year in a row with the American Cancer Society Cancer Action Network on a series of roundtables on personalized medicine in Utah, Georgia, Oregon, Nevada and Connecticut. • Creating and promoting several new educational materials, including primers on diagnostic test technology and the role of diagnostics in cancer care, as well as fact sheets on infectious disease, antibiotic resistance, and cervical cancer. AdvaMedDx Chairman John Bishop of Cepheid participates in a panel on diagnostics at an American Association for Clinical Chemistry meeting in Philadelphia in August. Vital Insights Transforming Care Beth Bell, director of the National Center for Emerging and Zoonotic Infectious Diseases at the Centers for Disease Control and Prevention, speaks at a March Capitol Hill briefing on infectious disease threats and the value of diagnostics, adjacent AdvaMedDx’s Andy Fish (at right).