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

ss="xn-chron">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
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SOURCE College of American Pathologists
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