By Stephanie Murg, Managing Director, G2 Intelligence
With the market and media momentum of direct-to-consumer (DTC) testing showing no signs of slowing, the American Association for Clinical Chemistry (AACC; Washington, D.C.) issued a position statement on direct-to-consumer laboratory testing. Released to coincide with the organization’s annual meeting, held July 26-30 in Atlanta, the statement calls for accuracy and transparency in DTC testing, emphasizing the need to ensure that results are easily understood.
As a result of the Patient Access Rule, effective October 2014, clinical laboratories are now required to provide patients or their authorized representatives with access to their completed test reports upon request. The rule preempts more restrictive laws in some states that previously limited patient access. Additionally, 37 states and the District of Columbia currently permit consumers to order some or all of their laboratory tests without the involvement of a physician.
Although DTC lab tests can provide valuable, timely information to individuals about their health status, many healthcare providers and policymakers are concerned that some of these tests may be of questionable quality and value, or that consumers might lack the background knowledge necessary to make sound decisions based on their test results.
In its position statement, AACC urges the Centers for Medicare and Medicaid Services and the Food and Drug Administration to require that DTC testing providers disclose sufficient information about their products and services, including user-friendly descriptions of risks, benefits, and limitations of all tests offered; clear and understandable reports of test results, with enough information to assist in decision-making; prominent instructions to contact a qualified healthcare provider with questions or concerns; and a comprehensive, public listing of tests offered and prices charged.
AACC also encourages lab professionals to collaborate with federal agencies to inform the public about the costs, benefits, interpretation, and limitations of direct-to-consumer tests. Likewise, consumers should consult qualified healthcare professionals about test results and when making decisions about their healthcare. According to AACC CEO Janet B. Kreizman, “Direct-to-consumer laboratory testing is a key element of ongoing efforts to empower people in decisions affecting their healthcare.”