Notes
1. Some terminological clarity is required. The term “direct-to-consumer” has been used describe two distinct models: firstly, where a firm advertises direct to the public, but the test must still be ordered by (and the results delivered to) a healthcare professional; and secondly, the more common model where a consumer buys directly from a firm, without the involvement of the consumer’s healthcare provider (in some instances the test may, in strict legal terms, be “ordered” by a healthcare professional employed by the firm solely for this purpose, but this does not establish a doctor–patient relationship with the consumer).