Self-Ordering Laboratory Testing: Limitations When a Physician Is not Part of the Model

Abstract

This review discusses considerations related to laboratory diagnostic testing purchased directly by consumers without the care and oversight of a medical doctor. There are necessary tensions between the patient, physician, laboratory medical professional (physician or scientist), laboratory as a corporate entity (where applicable), and manufacturers of diagnostic equipment. When the physician, in particular, the primary care physician, is removed from this relationship, there is a significant opportunity of exploitation of the patient. All downstream investigations following direct-to-consumer testing, including attendant risk, are offloaded onto the traditional medical system, caring physician(s), and patients themselves. This process places patients at risk of iatrogenic harm.

Keywords: CLIA-waived; Direct-to-consumer testing; FDA; Genetics; Genomics; Point of care; US Food and Drug Administration.