There’s no place like home: how consumer-initiated testing is revolutionizing access to care

The conventional model of clinical laboratory testing, in which tests are ordered by licensed healthcare providers and diagnostic specimens are collected at healthcare facilities, presents significant barriers to access for many patients. More patient-centered models, such as consumer-initiated — wherein individuals collect their own specimens at home and access results virtually — have grown rapidly in tandem with the increased availability of digital technology.

In short, direct-access testing is here to stay. Is the laboratory medicine community ready? Julie Shaw, PhD, FCACB, moderates the Monday afternoon scientific session, “Advances and Limitations of Consumer-Initiated Laboratory Testing,” that will tackle this timely question from practical, clinical, and ethical perspectives.

The session will feature three speakers with expertise in various elements of direct-access testing. At the beginning of the session, Dina Greene, PhD, DABCC, a clinical chemist who has extensively studied home-sample collection to expand testing access, will define direct-access testing, discuss sample collection and quality, and highlight the laboratory’s role. Greene points out that “all laboratory testing can be good or bad,” regardless of where samples are collected or where analysis takes place.

Greene will highlight examples of when patient-centered models work well, such as home collections for creatinine for chronic kidney disease and HPV for cervical cancer screening, two markers with established clinical utility and a documented need to expand access to vulnerable populations. Additionally, she’ll share examples of when such models do not work well, illustrated by an example of cortisol testing performed out of context.

Next, Melissa Budelier, PhD, DABCC, a clinical chemist with expertise in medical ethics, will introduce the four core principles of bioethics: respect for autonomy, beneficence, non-maleficence, and justice. She will then critically evaluate direct-access testing against these principles. For instance, how can we ensure that direct-access testing respects consumer autonomy? She will discuss a blood-based laboratory developed test for Alzheimer’s disease that has recently been removed from the consumer-initiated testing space due to misleading advertising, risk of significant patient harm from misinterpreting results, and the cost of the test.

Avantika Waring, MD, a clinician who delivers diabetes care virtually and regularly incorporates direct-access testing into her practice, will provide clinical commentary on the many real-life scenarios discussed throughout the session.

Attendees will come away from this holistic and dynamic session with a fresh take on the past, present, and future of consumer-initiated testing. There has never been a better time to engage with patient-centered models to expand access to vital laboratory tests and improve the quality of care.