News — WASHINGTON – The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released a position statement today supporting consumers’ efforts to play active roles in their healthcare by ordering their own laboratory tests. The statement emphasizes that such direct-to-consumer testing should be performed only by reputable laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) and that are committed to providing clear information and guidance to help consumers interpret the results.
Read the position statement here:
The new statement replaces a on this topic from 2019, noting the recent growth in the availability of direct-to-consumer testing due to technological advances and a surge in consumer interest. By 2030, the global market for these tests is likely to exceed $20 billion, according to the statement.
Today’s testing landscape offers consumers many options for accessing health information and taking part in their own healthcare. Unlike traditional lab tests that require a doctor’s order, direct-to-consumer testing allows people to directly order lab tests that can detect certain diseases, provide information about existing conditions, or shed light on how genetic or environmental factors affect their personal health. Moreover, results are often available quickly, adding to the tests’ appeal. At the same time, some tests may be of questionable value and quality, making it essential to improve consumer access to products that are accurate and reliable.
Laboratory professionals are committed to safeguarding consumers by ensuring the appropriate use of clinically relevant direct-to-consumer tests. ADLM calls on labs performing direct-to-consumer tests to explain the purpose of each test in an accessible and easily understandable way, detailing appropriate use, specimen-collection methods, risks, results interpretation, and cost to consumers. In particular, labs should provide prominent instructions for consumers to contact a qualified healthcare provider with any questions or concerns. Labs must also ensure customers’ data is handled safely and confidentially, while validating all sample collection, sample processing, and testing practices in accordance with CLIA regulations or guidance from the Food and Drug Administration.
The statement lays out additional guidance for healthcare providers, regulators, and policymakers, highlighting the need for all of these parties to consult with laboratory medicine experts on direct-to-consumer testing-related issues. Of special note, ADLM urges the Federal Trade Commission to vigorously prosecute direct-to-consumer testing providers that engage in misleading or fraudulent marketing and testing practices. The association also asks the Agency for Healthcare Research and Quality to encourage further research on outcomes associated with consumer-initiated versus conventional testing practices.
“Consumer-directed laboratory testing can provide valuable information to individuals about their health status in a timely and convenient manner,” said ADLM President Dr. Anthony Killeen. “Laboratory professionals are essential to empowering consumers to understand and manage their health through the appropriate use of these tests.”
About the Association for Diagnostics & Laboratory Medicine (ADLM)
Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit .
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