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U.S. Department of Health and Human Services

Medical Devices

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FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs), Date July 19-20, 2010

NOTICE: MEETING LOCATION HAS BEEN CHANGED. The public meeting has been changed to an alternative site in the Washington, DC metro area to accommodate the significant public response received and requests to attend the public meeting. Details on the new meeting site can be found below.



Date, Time and Location

The meeting was held on July 19 (8:00 a.m. to 5:00 p.m.) and July 20 (8:00 a.m. to 5:30 p.m.) at:

The Marriott Inn and Conference Center, UMUC
3501 University Blvd E
Hyattsville, MD 20783
Phone: 301-985-7300
www.marriott.com/wasumExit Disclaimer

Webcast

This meeting was webcast at no charge to participants, and will be available for up to one year following the meeting. No registration is required to attend the meeting via webcast.

To view the meeting via webcast please use the following links:

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Background

Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including being developed and validated, and offered, within a single laboratory. Thus, the FDA has not actively regulated most LDTs.

Initially, laboratories manufactured LDTs that were generally relatively simple, well-understood pathology tests or that diagnosed rare diseases and conditions that were intended to be used by physicians and pathologists within a single institution in which both were actively part of patient care. These tests were ordinarily either well-characterized, low-risk diagnostics or for rare diseases for which adequate validation would not be feasible and the tests were being used to serve the needs of the local patient population. In addition, the components of traditional LDTs were regulated individually by FDA as ASRs or other specific or general reagents, and the tests were (as is still true today) developed and offered in CLIA high-complexity laboratories with extensive experience in using the tests. Today, many LDTs use complex elements that may not be FDA-regulated. Further, these tests are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions and are often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of a patient’s pathologist and treating physician. In addition, even when FDA-approved tests are available for a disease or condition, laboratories often continue to use LDTs that have not been reviewed by the agency. Finally, an increasing number of LDT manufacturers are corporations with publically traded assets rather than hospitals or public health laboratories, which represents a significant shift in the types of tests developed and the business model for developing them.
At the same time, diagnostic tests are playing an increasingly important role in clinical decision making and disease management, particularly in the context of personalized medicine. As a result, LDTs that have not been properly validated for their intended use put patients at risk. Risks include risk of missed diagnosis, wrong diagnosis, and failure to receive appropriate treatment. FDA has the statutory authority to assure that devices, including LDTs, are safe and effective for their intended use. Indeed, in April of 2008, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), in its report entitled "U.S. System of Oversight of Genetic Testing," recommended that "FDA should address all laboratory tests in a manner that takes advantage of its current experience in evaluating laboratory tests."

The FDA recognizes that while the absence of FDA oversight may make it easier for laboratories to develop and offer tests on a rapid timeline, the absence of a level playing field creates a disincentive to innovation by other manufacturers whose tests are approved or cleared by the agency. As a result, diagnostics critical for patient care may not be developed in a manner that provides a reasonable assurance of safety and effectiveness.
In response to these public health risks, the agency has concluded that it should exercise its authority over LDTs. The public would then be assured that the tests used in the provision of healthcare, whether developed by a laboratory or other manufacturer, are safe and effective. However, the FDA recognizes that there are issues unique to the laboratory community that should be taken into consideration when the agency exercises its oversight. The agency also recognizes that the implementation of oversight requires careful consideration so that patients will receive the desired benefits of innovative, yet safe and effective, diagnostic tests, such as tests for rare diseases and conditions. In addition, it is important that the FDA provide a reasonable, predictable, and consistent regulatory policy for ensuring the safety and efficacy of LDTs and provide sufficient time for implementation. This policy should encourage innovation, improve patient outcomes, strengthen patient confidence in the reliability of these products, and may help reduce health care costs.

At this time, the FDA believes that a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health benefits and would like to hear from stakeholders, including laboratory professionals, clinicians, patients, and industry, to define the issues that pose the greatest risk to the public health. The public meeting announced in this notice will serve as a forum to discuss issues and stakeholder concerns surrounding LDT oversight.

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Session Descriptions

Session 1: Oversight of LDTs: Patient and Clinical Considerations

Session Description:
FDA invites the public to present their perspectives on the patient and clinical considerations that should be taken into account when considering oversight of LDTs.

Potential topics to be addressed through the public presentations:

  • What would patients and clinicians like to see done by the FDA with respect to LDTs? What is ideal? What is practical?
  • How might increased FDA oversight of LDTs affect patients and clinicians? What might be the benefits?
  • What are patient’s expectations with regard to results obtained by an LDT? How might increased oversight of LDTs affect these expectations?
  • What is the patient’s perspective regarding tests that are non-regulated versus regulated by the FDA?
  • Are physicians aware that a given diagnostic test may not have been cleared or approved by FDA? How might this knowledge affect clinical practice?
  • What are the reasons that a patient or physician might choose an LDT over an FDA cleared/approved IVD?
  • What are patient’s and clinician’s expectations regarding clinical validation of LDTs?
  • Examples or case studies related to LDTs

Panel Members: TBD

Session 2: Oversight of LDTs: Clinical Laboratory Challenges

Session Description:

FDA invites the public to present their perspectives on the potential challenges faced by clinical laboratories under greater oversight of LDTs.

Potential topics to be addressed through the public presentations:

  • What are the potential benefits of increased FDA oversight of LDTs?
  • What would you like to see done with respect to FDA oversight of LDTs? What is ideal? What is practical?
  • Suggested approaches of risk stratification of LDTs
  • What might be some of the specific challenges faced by clinical laboratories in meeting FDA regulations?
  • How might increased oversight of LDTs affect diagnostic test innovation?
  • How could increased oversight of LDTs affect diagnostics used for rare conditions?
  • How might increased oversight of LDTs affect reimbursement and/or the cost of diagnostic tests for the consumer?
  • What are the challenges associated with validation of LDTs for clinical laboratories?
  • What will the challenges be to clinical labs with respect to diagnostic test change control under greater oversight of LDTs?
  • Should the clinical and analytical validation requirements be different between FDA regulated and non-FDA regulated diagnostic tests?

Panel Members: TBD

Session 3: Direct to Consumer (DTC) Testing

Session Description:

FDA invites the public to present their perspectives on direct to consumer testing.

Potential topics to be addressed through the public presentations:

  • What are the major concerns associated with DTC testing?
  • What is the benefit of DTC testing? What are the risks? What is the cost?
  • Are there concerns that DTC testing could lead to consumer fraud?
  • Are patients taking medical action based upon preliminary diagnostic test claims? What are the risks and benefits?

Panel Members: TBD

Session 4: Oversight of LDTs: Education and Outreach

Session Description:  

FDA invites the public to present their perspectives on the education and outreach activities needed by clinical laboratories under greater oversight of LDTs.

Potential topics to be addressed through the public presentations:

  • What resources or educational opportunities are currently available to assist clinical laboratories in meeting FDA regulations? What would be needed?
  • What specific support will be needed by clinical laboratories from the FDA given greater LDT oversight?
  • How can physicians use new genetic information? Whose responsibility is it to ensure that physicians can use the information provided to them by LDTs?

Panel Members: TBD

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Agenda

DAY 1: Monday, July 19, 2010

8:00 a.m.Welcome and Announcements
Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
8:15 a.m.Opening Remarks
Joshua M. Sharfstein, MD., Principal Deputy Commissioner, Food and Drug Administration
8:30 a.m.FDA’s History with Laboratory Developed Tests (LDTs)
Courtney Harper, Ph.D., Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health
9:15 a.m.FDA/CDRH 101
Katherine Serrano, Office of in Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health
10:15 a.m.Break
10:45 a.m.FDA Considerations
Elizabeth Mansfield, Ph.D., Director for Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health
11:30 a.m.Lunch

Session 1: Oversight of LDTs: Patient and Clinical Considerations

1:00 p.m.

Public Presentations Session 1

Presenter 1: Roger Klein, M.D., Blood Center of Wisconsin, Medical College of Wisconsin
Presenter 2: Cara Tenenbaum, Ovarian Cancer National Alliance
Presenter 3: Richard Hockett, M.D., Affymetrix
Presenter 4: Sharon Terry, M.A., Genetic Alliance
Presenter 5: Benjamin Salisbury, Ph.D., PGxHealth, LLC
Presenter 6: Eric Lawson, Voisin Life Sciences
Presenter 7: Dan O’Leary, Ombu Enterprises, LLC
Presenter 8: Elizabeth Kearney, National Society of Genetic Counselors
Presenter 9: Daniel Poscover, Posky LLC
Presenter 10: Michael Stocum, Personalized Medicine Partners
Presenter 11: Deirdre Astin, New York State Department of Health, Wadsworth Center
Presenter 12: Mary Pendergast, Pendergast Consulting

2:15 pmBreak

2:45 pm

Public Presentations Session 1

Presenter 14: Judith Wilber, Ph.D., XDx
Presenter 15: Steve Williams, M.D., SomaLogic
Presenter 16: Winton Gibbons, Nanosphere, Inc.
Presenter 17: John G. Bartlett, M.D., Infectious Diseases Society of America
Presenter 18: Mark Linder, Ph.D., PGxl Laboratories
Presenter 19: Janet Trunzo, Advanced Medical Technology Association (AdvaMed)
Presenter 20: Sara Kenkare-Mitra, Ph.D., Genentech
Presenter 21: Saurabh Aggarwal, Parexel

3:45 p.m.

Session 1 Discussion
Session 1 Moderator: Brenda Evelyn, SBB (ASCP), Office of Special Health Issues, Food and Drug Administration

Session 1 Invited Commentators:
Steve Gutman, M.D., M.B.A., Blue Cross and Blue Shield Association
Col. Alan J. Magill, M.D., F.A.C.P., F.I.D.S.A, Walter Reed Army Institute of Research
Paul Radensky, M.D., J.D., McDermott Will Emery LLP
Cara Tenenbaum, Esq., Ovarian Cancer National Alliance

4:45 pm

Day 1 Wrap Up
Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health

DAY 2: Tuesday, July 20, 2010

8:00 a.m.

Day II Welcome, Announcements
Alberto Gutierrez, Ph.D.

Session 2: Oversight of LDTs: Clinical Laboratory Challenges

8:15 a.m.

Public Presentations Session 2:

Presenter 1: Victoria Pratt, Ph.D., Quest Diagnostics, Nichols Institute
Presenter 2: David Mongillo, American Clinical Laboratory Association
Presenter 3: Diane Allingham-Hawkins, Ph.D., Hayes, Inc.
Presenter 4: Michael Murphy, M.Sc., Conatus Consulting, LLC
Presenter 5: Elaine Lyon, Ph.D., Association for Molecular Pathology
Presenter 6: Richard Hodinka, Ph.D., Children’s Hospital of Philadelphia
Presenter 7: Mitch Nelles, Ph.D., XDx
Presenter 8: Anna Longwell, Longwell and Associates
Presenter 9: Kathy Hibbs, Genomic Health
Presenter 10: William Clarke, Ph.D., American Association for Clinical Chemistry
Presenter 11: Liz Lison, Advocea, LLC
Presenter 12: Klaus Schafer, M.D., TessArae, LLC
Presenter 13: Frank Cockerill, M.D., Mayo Clinic
Presenter 14: Paula Revell, Ph.D., American Society for Microbiology
Presenter 15: Pheobe Mounts, Morgan Lewis
Presenter 16: Michael P. Ryan, Ph.D., Wadsworth Center New York State Department of Health
Presenter 17: Elissa Passiment, American Society for Clinical Laboratory Science
Presenter 18: Bruce Davis, M.D., Clinical Cytometry Society, International Council for Standardization in Haematology and Trillium Diagnostics

 

10:00 a.m.

Break

10:15 a.m.

Public Presentations Session 2:

Presenter 19: Patrick Terry, European Personalized Medicine Coalition
Presenter 20: Gail Vance, M.D., F.C.A.P., College of American Pathologists (CAP)
Presenter 21: Richard Naples, Beckton Dickinson & Co
Presenter 22: Shashikan Kulkarni, Washington University School of Medicine
Presenter 23: Ted Snelgrove, Crescendo Bioscience
Presenter 24: Kathleen Rao, Ph.D., American College of Medical Genetics
Presenter 25: Andrea Zachary, Ph.D., American Society for Histocompatibility & Immunogenetics
Presenter 26: Georgirene Vladutiu, Ph.D., Kaleida Health Laboratories & SUNYAB & Pres., Society for Inherited Metabolic Disorders
Presenter 27: Judith Yost, M.A., M.T. (ASCP), Centers for Medicare and Medicaid Services
Presenter 28: John E. Tomaszewski, M.D., American Society for Clinical Pathology
Presenter 29: Joanne Bartkus, Ph.D., Minnesota Public Health Laboratory
Presenter 30: Bernard Sixt, Ph.D., Agendia
Presenter 31: Salvatore Salamone, Ph.D. Saladax Biomedical Inc.
Presenter 32: MaryDel Brady, CvergenX, Inc.
Presenter 33: Gualberto Ruano, M.D., Ph.D., Hartford Hospital
Presenter 34: Robert Middleberg, Ph.D., NMS Labs

12:00 p.m.

Lunch

1:30 p.m.

Session 2 Discussion:
Session 2 Moderator: Thomas Hearn, Ph.D., Center for Disease Control and Prevention

Session 2 Invited Commentators:
Karen P. Mann, M.D., Ph.D., Association for Molecular Pathology
Alan Mertz, American Clinical Laboratory Association
Richard Naples, Beckton Dickinson & Co, AdvaMed
Timothy O’Leary, M.D., Ph.D., Veterans Health Administration
Gail Vance, M.D., F.C.A.P., College of American Pathologists
Judy Yost, M.A., M.T. (ASCP), Division of Laboratory Services, Centers for Medicare and Medicaid Services

2:30

Break

Session 3: Direct to Consumer Testing

2:45 p.m.

Public Presentations Session 3:

Presenter 1: Anne Wojcicki, 23andMe, Inc.
Presenter 2: Adele Schneider, M.D., Albert Einstein Medical Center
Presenter 3: Edna Garcia, American Society for Clinical Pathology
Presenter 4: Jeremy Gruber, Council for Responsible Genetics
Presenter 5: Katherine Borges, International Society of Genetic Genealogy
Presenter 6: Destry Sulkes, M.D., Medivo, Inc.
Presenter 7: David Becker, Ph.D., Pathway Genomics
Presenter 8: Amy DuRoss, Navigenics
Presenter 9: Kenneth Emancipator, M.D., American Society for Clinical Pathology
Presenter 10: Paul Valenstein, M.D., College of American Pathologists
Presenter 11: Gaia Bernstein, Seton Hall University School of Law

3:45 p.m.

Session 3 Discussion:
Session 3 Moderator: Muin Khoury, M.D., Ph.D., Centers for Disease Control and Prevention

Session 3 Invited Commentators:
Sue Friedman, D.V.M., FORCE: Facing our Risk of Cancer Empowered
Susanne Haga, Ph.D., Duke Institute for Genome Sciences and Policy
Wayne A. Rosenkrans, Jr., Ph.D., Personalized Medicine Coalition
Vance Vanier, M.D., Navigenics
Ann Willey, Ph.D., J.D., Office of Laboratory Policy and Planning New York State Department of Health

Session 4: Oversight of LDTs: Education and Outreach

4:45 p.m.

Public Presentations Session 4:

Presenter 1: Mya Thomae, MyRAQA, Inc.
Presenter 2: Ashley Gould, 23andMe, Inc.

5:00

Session 4 Discussion:
Session 4 Moderator: Joan Scott, M.D., C.G.C., Genetics Public Policy Center, Johns Hopkins University

Session 4 Invited Commentators:
William Castellani, M.D., F.C.A.P., College of American Pathologists
Kathy Hudson, Ph.D., National Institutes of Health
Elisabeth Kato, M.D., M.R.P., Agency for Healthcare Research and Quality
Sharon Terry, M.A., Genetic Alliance

5:45

Meeting Wrap-Up
Alberto Gutierrez, Ph.D.

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Transcripts

 

July 19, 2010 Meeting Transcript [PDF]

July 20, 2010 Meeting Transcript [PDF]

 

Contacts

The workshop organizer may be contacted at:

Katherine Serrano
Center for Devices and Radiological Health
Building 66, Room 5613
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone: (301) 796-6652
E-mail: katherine.serrano@fda.hhs.gov