College of American Pathologists

  Laboratory Developed Test
  Oversight Should be


Published September 24, 2009


The College of American Pathologists today announced new recommendations for strengthening oversight of laboratory-developed tests (LDTs), proposing a three-tier ‘risk based’ system that would protect patients by ensuring every laboratory developed test is reported to an oversight body, and instituting a graduated system of review based on a test’s potential risk to patients.

CAP’s proposed changes would incorporate oversight of claims of clinical validity, and specify scientific and regulatory standards to be applied to all LDTs. Risk would be determined based on claims made, potential risk to patients, and the extent to which a test’s results could be used in the determination of diagnosis or treatment.

CAP believes optimum oversight would be achieved by applying a risk-based classification (low-, moderate-, or high-) to each LDT; strengthening CLIA accreditation standards on labs using low- and moderate-risk LDTs, and requiring Food and Drug Administration (FDA) review of all high-risk LDTs.

LDTs are defined as medical tests performed by the laboratory in which the test was developed, and the test is neither FDA-cleared nor FDA-approved. The quality of LDTs is currently assured by the Center for Medicare and Medicaid Services (CMS) through the authority of the Clinical Laboratory Improvement Amendments (CLIA); FDA has claimed jurisdiction but exercised enforcement discretion with regard to LDTs. Due to the growth in the quantity and complexity of LDTs, the College believes updates to existing LDT oversight procedures have become necessary.

“While the preponderance of laboratory developed tests present relatively low risk to patients, the increasing use and complexity of some LDTs underscores the need for increased oversight,” said Jared N Schwartz, MD, PhD, FCAP, president of the College of American Pathologists. “CAP’s risk-based model employs a public private partnership to address oversight of these tests in an inclusive, systematic way.”

CAP believes FDA should continue to exercise enforcement discretion in regulating LDTs, asserting authority only in specific instances where FDA regulators believe implementation of an LDT without direct FDA oversight is not appropriate.

The College will continue to work with federal agencies and stakeholders to ensure that the quality standards and safeguards applied to LDTs evolve in step with the technological advances that have made them so effective in the diagnosis and treatment of disease.

Comments and questions are being accepted by Helena Duncan.


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