CLN Daily
Allowing patients to order their own laboratory testing is a tricky proposition, one that comes with unique challenges and considerations. This transformation of patients into “consumers” was the subject of the interactive session “Direct-to-Consumer and Direct Access Testing: A Discussion from Clinical, Laboratory, and Informatics Viewpoints,” which featured an international panel of speakers from Canada, Germany, and the United States.
Session moderator and speaker Julie Shaw, PhD, stressed that terminology is important. Direct access testing (DAT) is medical-grade laboratory testing ordered by a consumer and performed in a clinical laboratory. Direct-to-consumer testing (DTC) is also ordered by the consumer but is typically performed using non-medical grade laboratory testing and may be tested in non-accredited laboratories.
Shaw, who oversees clinical testing in at her institution in Canada, cited affordability, ease of access, and anonymity as key drivers for the use of DAT/DTC among consumers worldwide. The utility of DAT/DTC has thus far been best demonstrated in sexually transmitted infection testing, reaching people who otherwise would be reluctant or unable to get access to testing.
However, not all DAT/DTC testing has shared this success story. Perhaps the most public example in recent years has been the controversy of DTC genetic testing. Shaw warned that the presence of a genetic variant does not always equate to clinical meaning and that clinical support is critical for interpretation of test results.
This holds true for all DAT/DTC testing, genetic or otherwise. DAT/DTC testing should always have demonstrated clinical utility, but Shaw also emphasized that the labs must be accredited and clinical support is required.
Matthias Orth, MD, PhD, provided a European view of the health data space involving DTC. Orth said that in Germany, DTC results are problematic, siting European laws that require clinician follow-up of any abnormal results, regardless of the quality or accuracy of the testing. There is also a concern about potential invalidation of patient medical records when inaccurate test values are identified. This issue has created a significant burden on the healthcare system there, he noted.
“The more we test, the more positives we see,” Orth said. “This is creating over-medicalization, non-existent disease and marketing-created health needs.”
As a chief medical information officer and a medical director of informatics in the United States, Michelle Stoffel, MD, PhD, MSc, is interested in the health informatics of DAT testing. In her talk she outlined the unique informatics needs of a DAT program in which there is a complete paradigm shift: the consumer replaces the provider and assumes responsibility for test selection, interpretation, and follow-up.
Interoperability, the exchange of information between two entities, is the main barrier to integration of DAT in healthcare, Stoffel said. Health institutions have been reluctant to incorporate DAT results into the health record. One hesitation is that there is not yet a way to indicate in the health record when a test was patient-initiated.
Stoffel also said that some providers have concerns that chain of custody is not adequately controlled, calling into question the accuracy of the results due to risks for preanalytical error. Stoffel pointed out, however, that some clinician-ordered testing, such as FIT testing for colorectal cancer screening and some urine collections, already are managed by patients outside the clinical setting.
The session concluded with an active discussion among the speakers and attendees. Attendees’ primary concerns were the ethics of DAT/DTC, including test utilization, access to care—especially in rural environments—quality standards, and the regulatory landscape.
Despite some concerns with DAT/DTC, a poll of attendees revealed that 50% have at some point consulted on DAT/DTC results provided by a patient and over 60% had ordered DAT/DTC testing for themselves. So, is DAT/DTC testing friend or foe? The jury is still out, but the right discussions have begun.