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

cacy/ldt/oversight_model.pdf">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 '/>"/>

SOURCE College of American Pathologists
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