In recent weeks, the FDA has sent warning letters to other companies regarding their direct-to-consumer testing, including DNA4Life on their Pharmacogentic Report that analyzes a patient’s gene to assess the risk of known potential ADRs and drug efficacy,11 which the FDA has declared to meet the definition of a Class I medical device. The Agency has also released a report of 20 case studies of laboratory developed tests (LDTs) and direct-to-consumer tests with known or potential false-positives, false-negatives, false-positives and false-negatives, tests linked to treatments based on disproven scientific concepts, and tests that undermine drug approval or drug treatment selection for tumor HER2 receptors, human papillomavirus, immune cytokine markers in fibromyalgia, KIF6 variant for heart disease risk and statin response, a mouse virus with a reported link to chronic fatigue syndrome, autism spectrum disorder (ASD), heavy metals, gene mutation in cancerous cells, chronic myelogenous leukemia (CML), or vitamin D, among others.12


As diagnostic technology becomes more refined and precision medicine moves into the forefront of healthcare, the role of these and other direct-to-consumer tests will become increasingly prominent and scrutinized by government regulatory agencies. As of now, the efficacy and benefits to patients are largely unknown and may actually lead to worse care if interpreted outside of a clinical setting. Until these services have been more thoroughly vetted and analyzed, clinicians are advised to be cautious of these products.

Continue Reading