Event Materials

U.S. House Energy and Commerce Subcommittee on Health Hearing on

"21st Century Cures: Examining the Regulation of Laboratory Developed Tests"

September 9, 2014

AdvaMedDx Executive Director Andrew Fish testified before the U.S. House of Representatives Energy and Commerce Committee in support of FDA taking a risk-based approach to the regulation of lab-developed tests (LDTs), which have grown increasingly complex over the last decade and are relied upon by doctors and patients to guide critical health care decisions.

To view the written testimony click here.

The full webcast of the hearing can be found here.

Blood Safety: The Importance of Diagnostics and Devices

June 6, 2014

Rayburn House Office Building B-369

Washington, DC

AdvaMedDx heald a Capitol Hill briefing on the life-saving role of diagnostics and devices to ensure that the U.S. blood supply is safe.

For patients needing transfusions, the U.S. blood supply has never been safer. Thanks to advanced diagnostic testing, innovative devices and other blood safety interventions, it's now rare that someone would ever receive Hepatitis or HIV-infected blood. Health care providers and industry want to apply this same low tolerance for infectious disease risk in blood to another area of transfusions: post-transfusion adverse reaction. This is especially critical for patients that require more frequent transfusions, such as those with Sickle Cell Disease, thalassemia and some patients with cancer. These chronic patients can become highly sensitized to blood transfusions, making it difficult to find the right match. While they can be matched for the two major types of blood groups, there are over a dozen less common blood groups that can also be problematic for them.

Today there are new molecular diagnostic tests that make it possible to quickly and cost-effectively perform extended matching for donors and patients. For patients, this means the possibility of faster access to highly matched blood and a better chance of avoiding adverse transfusion reactions. 

Featured speakers included:

  • Dr. Sukanta Banerjee, Senior Director of R&D, BioArray Solutions (an Immucor Company)
  • Dr. Arthur Bracey, Pathologist, Gulf Coast Pathology, Blood Banking and Transfusion Medicine
  • Dr. Louis Katz, Chief Medical Officer, America’s Blood Centers
  • Joann Moulds PhD, MT(ASCP)SBB, Scientific Director, Grifols Immunohematology Center

To view the videos from the Hill visiting, please click here.

Personalized Medicine in Oncology Practices Event at ASCO Annual Meeting

June 2, 2014

Hyatt Regency Chicago

AdvaMedDx partnered with the American Cancer Society Cancer Action Network (ACS CAN), the Association of Community Cancer Centers (ACCC), and the Ovarian Cancer National Alliance (OCNA) to organize a diagnostics focused briefing during the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago that was held Monday, June 2 at the Hyatt Regency Chicago. This event featured:

  • Dr. Ed Braud, Past President, Association of Community Cancer Centers
  • Dr. Laura Koontz, Director of Policy, Ovarian Cancer National Alliance
  • Dr. Len Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society
  • Tom McLain, Former President and CEO, Vermillion
  • Mary Lou Smith, JD, MBA, Co-Founder, Research Advocacy Network

Representatives from the patient advocacy community, physicians, and the diagnostics and pharmaceutical industry attended this event.

World Health Assembly Diagnostics Briefing

May 20, 2014

Hotel InterContinental Geneva, Switzerland

AdvaMedDx, the European Diagnostics Manufacturers Association (EDMA), and the Global Medical Technology Alliance (GMTA) held the third annual diagnostics briefing at the World Health Assembly on Tuesday, May 20 in Geneva.  This year's briefing was titled "The Fight Against Antimicrobial Resistance: Are Diagnostics Winning?" and featured the following speakers:

  • Jennifer Cohn, Medical Coordinator, Médecins Sans Frontières Access Campaign
  • Philippe Jacon, Executive Vice President of International Commercial Operations, Cepheid (Moderator)
  • Martha Gyansa Lutterodt, Director of Pharmaceutical Services, Ghana Ministry of Health
  • Robert Matiru, Portfolio Manager HIV/AIDS, UNITAIDFrancis Moussy, Scientist, World Health Organization

Over 60 representatives from health ministries, WHO, and NGOs attended this briefing.

 

DxMA Webinar - U.S. Market Statistics Survey: A New Source of IVD Sales Data
January 30, 2014

As part of its service to members, AdvaMedDx launched the U.S. Market Statistics Survey in 2013. The survey complements the Global Diagnostic Market Statistics program developed by the European Diagnostic Manufacturers Association (EDMA).  After many years, EDMA’s program now covers over 85% of IVD market sales in 14 European countries.

The AdvaMedDx program, based on confidential shared sales data from 16 founding member companies, provides detailed insights on market size, market share and market evolution in the United States.

To view the slides from the webinar, please click here.

 

AdvaMedDx - CDC Capitol Hill Briefing & Product Showcase

December 5, 2013

Rayburn House Office Building

AdvaMedDx and the Centers for Disease Control and Prevention (CDC) collaborated on an infectious disease briefing on Capitol Hill.

Speakers:

  • Beth Bell, MD, MPH, Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

  • Douglas Bryant, President and Chief Executive Officer, Quidel

  • John Hackett, Jr., PhD, Director of Diagnostics Infectious Disease Research, Abbott

  • Thomas Kenyon, MD, MPH, Director, Center for Global Health, Centers for Disease Control and Prevention

  • Todd Summers, Senior Adviser at Global Health Policy Center, Center for Strategic and International Studies (Moderator)

 

The videos from this briefing can be viewed here.

AdvaMedDx - AACR Cancer Diagnostics Symposium

October 29, 2013

Washington, DC - The Grand Hyatt Hotel

AdvaMedDx partnered with the American Association for Cancer Research to organize a day-long symposium focused on cancer diagnostics. "Transforming Cancer Care Through Diagnostics and Personalized Medicine" was held on Tuesday, October 29th at the Grand Hyatt Hotel in Washington, DC.

Over 250 individuals attended the symposium. Speakers included Dr. Francis Collins, Director of the National Institutes of Health; Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration; Dr. Harold Varmus, Director of the National Cancer Institute; and a number of diagnostics experts from academia, industry, government, and industry. 

At the symposium, Commissioner Hamburg announced the releasethe report Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development which describes many of the developments and advances in personalized medicine.

The agenda from this event can be found here.

To view the videos of the presentations and panel discussions, please click here.

The slide presentation from the event can be downloaded here.

 

Webinar on Essentials of Diagnostics: Introduction to Molecular Diagnostics Report

July 9, 2013

12:00 pm EDT

Dx Insights and AdvaMedDx hosted a webinar on the “Essentials of Diagnostics: Introduction to Molecular Diagnostics” report which highlights the evolution of molecular diagnostics, current trends in advancing technologies, and opportunities for the future.

The webinar was led by Kristin Pothier, Partner at Health Advances and a Founder of DxInsights, and Andrew Fish, Executive Director of AdvaMedDx.

To view the presentation from the webinar, please click here.

Hill Briefing: Fighting Antibiotic Resistance through Innovation

June 3, 2013

B-339 Rayburn House Office Building

AdvaMedDx hosted a Capitol Hill briefing on the topic of antibiotic resistance on Monday, June 3rd. Antibiotic resistance is quickly becoming one of the world's most pressing health problems. Drug resistant bacteria and other microbes are associated with a variety of illnesses that threaten to make commonly treatable infections untreatable.

Diagnostic manufacturers are developing critical tools to help physicians and patients make the most informed treatment decisions possible and reduce the threat of antibiotic resistance.  The effort to reduce antibiotic resistance will require a multi-faceted effort on all levels involving researchers, health care providers and government agencies.

The panel discussion featured:

  • Regina Davis Moss, PhD, MPH, MCHES, Associate Executive Director of Public Health Policy and Practice, American Public Health Association
  • Mike Musgnug, Vice President of Respiratory and Healthcare Associated Infections, Alere
  • Lance R. Peterson, MD, Director of Microbiology and Infectious Diseases Research, NorthShore
  • Dr. Teresa Raich, Vice President of Clinical and Scientific Affairs, Nanosphere
  • Cynthia L. Sears, MD, FIDSA, Treasurer, Infectious Diseases Society of America, Professor of Medicine and Oncology, Johns Hopkins University School of Medicine

To view the presentation, please click here.

To watch the briefing video, please click here.

 

Diagnostics Briefing at the World Health Assemby

May 21, 2013

Intercontinental Hotel

Geneva, Switzerland

AdvaMedDx, the European Diagnostics Manufacturers Association (EDMA), and the Global Medical Technology Alliance (GMTA) held our second annual diagnostics briefing at the World Health Assembly. This year's briefing focused on the "Early Detection and Treatment of Noncommunicable Diseases."

The panel briefing featured:

Christian Fischer, Senior Medical Director for Europe, Abbott
Prof. Fred Harms, Vice President, European Health Care Federation
Phillippe Jacon, Executive Vice President of Emerging Markets, Cepheid (Moderator)
Francis Moussy, Ph.D., Leader of Initiative on Innovation for Ageing Populations, WHO
Johanna Ralston, Chief Executive Officer, World Heart Federation
Victor Shi, Asia Pacific President, QIAGEN

A cocktail reception and product showcase followed the panel discussion.

To view the agenda, please click here.

To view the speaker bios, please click here.

 

The Role of Diagnostics in Protecting and Promoting Women’s Health

December 12, 2012

AdvaMedDx held its third briefing on Capitol Hill "The Role of Diagnostics in Protecting and Promoting Women’s Health", on December 12th.

The briefing featured Carl Hull, SVP and General Manager of Diagnostics at Hologic Gen-Probe, and Bonnie Rib, VP and General Manager of Women’s Health and Cancer at BD, who discussed how diagnostic tests are used to screen and treat sexually transmitted diseases and cervical cancer. Patient advocates Lisa Hill, a breast cancer survivor, and Jennie McGihon, an ovarian and uterine cancer survivor, shared their experience with fighting cancer and the importance of diagnostics in their treatment.  

Representative Erik Paulsen (R-MN), Co-Chair of the House Medical Technology Caucus, opened the briefing by remarking on how diagnostics are an essential component in treatment and health care.

To view the presentation, please click here.

To watch the briefing video, please click here.

The Role of Advanced Diagnostics in Cancer

September 20, 2012

AdvaMedDx held a second briefing on Capitol Hill, "The Role of Advanced Diagnostics in Cancer Care", on September 20th. The briefing featured speakers who discussed how advanced diagnostics are delivering on the promise of personalized medicine by improving the ways we detect and treat cancer. The briefing drew over 70 attendees from Congressional offices, advocacy associations, provider groups, and press.

  • Amalia M. Issa, PhD, MPH, Chair of the Department of Health Policy and Public Health and Director of the Program in Personalized Medicine and Targeted Therapeutics, University of the Sciences, gave a presentation on the science and application of personalized medicine in clinical practice, with regard to genomic medicine and how new molecular diagnostic tests are transforming cancer care.

  • Cesar Garcia, President and CEO of IRIS International, presented a background on the NADIA ProsVue test.  This innovative molecular prostate test was approved by the FDA in 2011.  Mr. Garcia detailed how ProsVue is positively influencing decisions on follow-up care for the post-prostatectomy population (95,000 people a year in the United States), and noted that improvements to the regulatory and reimbursement systems are necessary to support and expedite the implementation of this kind of innovation throughout the diagnostics industry.
  • Walter Koch, PhD, Vice President and Head of Global Research, Roche Diagnostics, presented on Roche's  ZELBORAF™ and cobas® BRAF test co-development for late-stage melanoma patients.  He discussed the improved value proposition molecular diagnostics offered to all involved stakeholder groups, as well as the challenges created by inconsistent regulatory requirements and oversight for manufacturers and investors.
  • Marcia Horn, President & CEO of the International Cancer Advocacy Network, wrapped up the briefing with remarks on how molecular diagnostics are benefitting cancer patients.

The panel discussion was moderated by AdvaMedDx Executive Director Andrew Fish. 

To view the presentation, please click here.

To watch the briefing video, please view below or click here.

 

When Minutes Matter: Critical Care Diagnostics

June 21, 2012

AdvaMedDx held a briefing on Capitol Hill, When Minutes Matter: Critical Care Diagnostics, on June 21, 2012. The briefing featured speakers who discussed the essential role of diagnostics in critical care settings from the battlefield to the emergency room.

Frank Peacock, MD, Emergency Medicine Research Director at the Baylor College of Medicine, shared an emergency room physician’s perspective on point of care tests. He discussed how point of care tests in the emergency room help effectively diagnose heart failure and other conditions in a matter of minutes. Dr. Peacock reviewed key studies to underscore his message that point of care tests get patients better care faster, , reducing the length of stay in emergency rooms and resulting in better outcomes.

Jackson Streeter, MD, Chief Executive Officer of Banyan Biomarkers, Inc., discussed a point of care test that his company is developing for the diagnosis of mild, moderate, and severe Traumatic Brain Injury (TBI). This first of its kind test will help emergency physicians and EMTs quickly detect and quantify TBI, which is a factor in approximately 1.7 million ER visits and affects 30,000 military personnel. Dr. Streeter is developing this test to work on a hand-held device ready for battlefield and EMT use.

The panel discussion was moderated by AdvaMedDx Executive Director Andrew Fish.

The briefing drew over 60 attendees from Congressional offices, advocacy associations, provider groups, and trade press.

To view the presentation, please click here.

Capitol Hill Briefing Videos

 

World Health Assembly Diagnostics Briefing and Reception

May 23, 2012

AdvaMedDx, the European Diagnostics Manufacturers Association (EDMA), and the Global Medical Technology Alliance (GMTA) hosted a first-of-its kind briefing on the occasion of the 65th World Health Assembly (WHA) in Geneva titled “Innovation for Infectious Disease Diagnostics in Low Resource Settings - Influenza Preparedness and Beyond.”

The briefing, held on May 23, 2012, was successful in raising the awareness among key stakeholders of the value that diagnostics provide in advancing global public health and some of the key distinguishing factors of the diagnostics sector that impact policy development. The briefing was intended to enhance the dialogue between the diagnostics industry and Geneva-based stakeholders and that AdvaMedDx, EDMA and GMTA are seeking to have ongoing robust and constructive discussions to help advance participants’ shared goals of preventing and managing disease around the world by improving health systems and harnessing diagnostic technology.

The keynote speech was delivered by Foundation for Innovative New Diagnostics (FIND) CEO Philippe Jacon. Mr. Jacon emphasized the importance of diagnostic tests in health care and the need for more tests in low resource settings. He emphasized that accurate diagnosis is essential to ensure treatments are used appropriately in order to avoid mistakes of misuse of drugs that have contributed to antibiotic resistant pathogens.

Speakers from the diagnostics industry included Anthony Lakavage, Worldwide Vice President of Public Affairs from BD, Véronique Baron-Wunderle, Global Marketing Director from bioMerieux, and Knut Seifert, Country Manager from Roche Diagnostics South Africa. Speakers described the complementary role of point of care diagnostics and laboratory-based diagnostics in addressing the healthcare needs of developing countries. Speakers also described ways in which industry to partnering with other stakeholders to overcome barriers to access to diagnostic technologies in developing countries. Examples include innovative business models and public-private-partnerships (such as with FIND), to develop and make available diagnostic technologies suitable for low-resource settings. 

Lorenzo Llewellyn Witherspoon, Head of Procurement at UNITAID, provided remarks that included an overview of UNITAID funding for lab structures and emphasized the role diagnostic tests play in preventing the public from getting sicker. “We must be as innovative as the diseases themselves and build partnerships to diagnose patients early, and put them on the right treatment at the right time so we can stop the diseases in their tracks,” Witherspoon said.

AdvaMedDx and EDMA member companies Alere, BD, bioMerieux, Cepheid, HemoCue AB and Roche contributed to the success of this event by showcasing their diagnostic tests for HIV, TB, influenza, cervical cancer, glucose, and hemoglobin.

  • To view the agenda, please click here.
  • To view the speaker bios, please click here.