Navigation Links
CAP Leaders Stress Need for Oversight of Direct-to-Consumer and Laboratory Developed Tests
Date:7/20/2010

College of American Pathologists Outlines Recommendations at Food and Drug Administration Meeting

WASHINGTON, July 20 /PRNewswire-USNewswire/ -- With the increasing importance of laboratory tests in diagnosing and treating disease, representatives of the College of American Pathologists (CAP) today presented recommendations to the Food and Drug Administration (FDA) urging increased oversight of laboratory developed tests (LDTs) and "direct-to-consumer" tests. Most genetic tests fall into one or both of these testing categories.

"As physicians responsible for ensuring laboratory quality and rendering diagnoses based on laboratory tests, the CAP believes there is a need for FDA to increase its oversight of certain laboratory developed tests, including high-risk and direct-to-consumer tests," said Gail Habegger Vance, MD, professor of Medical and Molecular Genetics at the Indiana University School of Medicine (IUSM) in Indianapolis and a member of the CAP Board of Governors.  

Since the implementation of the 1976 Medical Device Amendments, the FDA has generally not used its oversight authority to enforce applicable regulations with respect to LDTs.  The FDA convened today's meeting to hear testimony about key issues that it will consider as it develops new regulations that would apply risk-based oversight of LDTs.

Late last year, the College introduced its own model for increased oversight of LDTs, and shared it with the FDA at that time. The CAP's proposed model for increased oversight of LDTs is featured on the College's Advocacy site.

In regards to the FDA panel on "direct-to-consumer" or DTC testing,  Paul N. Valenstein, MD, CAP governor and president of Pathology and Laboratory Management Associates in Ann Arbor, Mich., presented on behalf of the CAP. Patients deserve to be gatekeepers of their health information, but they also may need a medical professional to interpret the test results and recommend next steps, according to Valenstein.

"DTC testing is clinical laboratory testing and should be subject to appropriate safeguards," he added.  "We need to protect patients from deceptive or unscrupulous marketing or promotion of DTC testing.  This also includes relevant protections under the Health Insurance Portability and Accountability Act (HIPAA) and relevant state privacy laws."

DTC tests have recently come under scrutiny as several companies are poised to sell genetic test kits to consumers through pharmacies, without requiring the consultation of an ordering physician. Valenstein highlighted a number of areas where problems can arise when tests are administered by lay people outside a medical laboratory. These include ensuring the competency of testing personnel, software and document controls, and other good laboratory practices required to produce accurate results.

CAP's Proposed Model for LDT Oversight

Addressing the larger issue of LDTs, Vance noted that LDTs reside in a grey area between the FDA's regulation of test manufacturers and the Center for Medicare and Medicaid Services' (CMS) regulation of clinical laboratories under CLIA.  She then presented the CAP's proposed three-tier, risked-based classification system, announced in September 2009, to address how LDTs could be regulated.  

Under the CAP recommendations, tests are classified in the following manner and with the corresponding FDA oversight:

  • Low Risk:  The consequence of an incorrect result or incorrect interpretation is unlikely to lead to serious morbidity/mortality.  The laboratory performs analytical validation and determines adequacy of clinical validation prior to offering clinical testing.  The accreditor during the normally scheduled inspections verifies that the laboratory performed appropriate validation studies.
  • Moderate Risk:  The consequence of an incorrect result or incorrect interpretation may lead to serious morbidity/mortality and the test methodology is well understood and independently verifiable.  The laboratory must submit validation studies to the CMS-deemed accreditor for review and the accreditor must make a determination that there is adequate evidence of analytical and clinical validity before the laboratory may offer the test clinically.
  • High Risk: The consequence of incorrect result or incorrect interpretation could lead to serious morbidity/mortality is not well understood or is not independently verifiable.  The laboratory must submit the test to the FDA for review prior to offering the test clinically.  CMS and the accreditor must determine compliance.

"The CAP believes the FDA should adopt a classification system that will preserve safety while allowing ongoing innovation," said Vance.  "We believe this system, which would establish standards for classifying LDTs as low, moderate and high risk, will result in clear standards that laboratories can execute independently."

Vance thanked the FDA for hosting a public forum where these issues could be addressed, and urged FDA to continue to follow the standard rulemaking process in developing new oversight guidelines.

The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of board-certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care.


'/>"/>
SOURCE College of American Pathologists
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Hospital to Hold MRSA Briefing for Media and Community Leaders
2. AIDS Action Council Statement on World AIDS Day 2007: Leadership Needed for a National Strategy to Stop the AIDS Epidemic
3. SpineMark Partners With Regional Spine Leaders to Launch Its First Multisite Spine Research Organizations in Los Angeles, Denver
4. Intercell AG to Acquire Iomai Corporation to Expand Late Stage Product Pipeline and Strengthen Leadership in Vaccine Innovation
5. Stereotaxis Market Leadership Reinforced in Core Curriculum and Symposium Presentations at Heart Rhythm 2008
6. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
7. BBK Worldwide Celebrates 25th Anniversary of Industry Leadership Through Innovation in Patient Enrollment
8. Nations Foremost Health Care Leaders Kick Off Summit Focused on Zero-Tolerance Approach to Hospital-Acquired Infections
9. Evalve Expands Executive Leadership Team
10. Faith and Civil Society Leaders Call for Truth and Leadership in U.S. HIV Prevention Efforts
11. NewCardio Leadership to Present Two Abstracts at ISCE Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating ... many ways they remain in the eye of the beholder, according to experts who ... of The American Journal of Managed Care. For the full issue, click here ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
(Date:6/25/2016)... D.C. (PRWEB) , ... June 25, 2016 , ... ... discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, ... their work on several important health care topics including advance care planning, healthcare ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
Breaking Medicine News(10 mins):