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

Wed, 06/16/2010 - 5:35am
U.S. Food & Drug Administration

The meeting will be 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 Crowne Plaza Rockville. The hotel is at the following location:

Crowne Plaza Rockville, Maryland/Washington, DC

3 Research Court

Rockville, MD 20850

Hotel Phone: (301) 840-0200

Hotel Website:


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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 patientâ??s health care setting under the supervision of a patientâ??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 Secretaryâ??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 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 patientâ??s expectations with regard to results obtained by an LDT? How might increased oversight of LDTs affect these expectations?
  • What is the patientâ??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 patientâ??s and clinicianâ??s expectations regarding clinical validation of LDTs?
  • Examples or case studies related to LDTs

 Panel Members: TBD

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 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 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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Day 1 Agenda

July 19, 2010

8:00 â?? 8:15 Welcome and Introduction
8:15 â?? 9:00 FDAâ??s history with Laboratory Developed Tests
9:00â?? 10:00 FDA 101
  • Description of our regulatory structure including overview of device classification, premarket applications, quality systems regulation
10:00â?? 10:30 Break
10:30 â?? 11:30 FDAâ??s expectations for the meeting, intentions toward regulation of LDTs (broad overview)
11:30 â?? 1:00 Lunch

Session 1: Oversight of LDTs: Patient and Clinical Considerations

1:00 â?? 3:00 Public Presentations Session 1
3:00 â?? 3:30 Break
3:30 - 4:30 Panel Discussion Session 1
  • Panel consisting of FDA staff and industry, laboratory, clinical, academic experts.
4:00 â?? 4:45 Day 1 Wrap Up

Day 2 Agenda

July 20, 2010

8:00 â?? 8:10 Day II Welcome, Announcements

Session 2: Oversight of LDTs: Clinical Laboratory Challenges

8:10 â?? 10:00 Public Presentations
10:00â?? 10:15 Break
10:15â?? 10:00 Public Presentations
11:00 â?? 12:15 Panel Discussion Session 2
  • Panel consisting of FDA staff and industry, laboratory, clinical, academic experts.
12:15 â?? 1:30 Lunch

Session 3: Direct to Consumer Testing

1:30 â?? 2:30 Public Presentations Session 3 Cont
2:30 â?? 3:15 Panel Discussion Session 3
  • Panel consisting of FDA staff and industry, laboratory, clinical, academic experts.
3:15 â?? 3:30 Break

Session 4: Oversight of LDTs: Education and Outreach

3:30 â?? 4:30 Public Presentations Session 4
4:30 â?? 5:30 Panel Discussion Session 4
  • Panel consisting of FDA staff and industry, laboratory, clinical, academic experts.

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Online registeration for the conference is available.

There is no registration fee to attend the meeting, but attendees must register in advance. Please submit registration early in order to reserve a space, as space is limited. You may register on-line until  July 12, 2010; however, on-site registration will be permitted if space remains. If you require special accommodations due to a disability, please contact the hotel at (301) 840-0200, at least 7 days prior to the meeting.

FDA welcomes the attendance of the public at this meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you need special accommodations due to a disability, please contact the Crowne Plaza, Rockville, MD/Washington, DC at (301) 840-0200 at least 7 days in advance of the meeting.

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If presenting, please do the following:

  1. Indicate the session(s) in which you would like to present in rank order. (See session descriptions.)
  2. Please provide an electronic copy of your presentation by July 12, 2010 to Katherine Serrano at:

Please note that you will initially be assigned to present in the session you have ranked as your highest priority. You may also be allowed to present in additional sessions should space permit.

All requests to present will be on the first come first serve basis and will be confirmed by phone or e-mail by July 1, 2010.

If you only wish to attend and not present, you can ignore these selections and submit your registration.

Rank #1:

Rank #2:

Rank #3:

Rank #4:


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





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