Direct-to-consumer testing - benefits for consumers, people with disease and public health.

Direct-to-consumer (DTC) tests can be defined as any in-vitro diagnostic (IVD) test or, more broadly, any medical test using an IVD or medical device, that is marketed directly to consumers without involvement of a health care provider (HCP). Examples are pregnancy tests, alcohol breath tests, blood pressure measurements (medical device), coagulation tests (INR), self-monitoring of blood glucose, continuous glucose monitoring (medical device), HIV tests, HPV tests, SARS-CoV-2 antigen tests, or genetic tests. DTC tests fulfil various customer needs such as making rapid decisions (e.g. glucose monitoring for insulin dosing, SARS-CoV-2 antigen test, hormone test identifying fertile days, alcohol test), monitoring chronic conditions between consultations (e.g. diabetes, lipidaemia, hypertension), saving time and reducing consultations (e.g. INR, SARS-CoV-2 antigen test, blood pressure monitoring), screening for disease when no symptoms are present (e.g. occult blood, cholesterol, triglycerides, SARS-CoV2 antigen test), or maintaining privacy (e.g. pregnancy test, HIV test, HPV test, certain genetic tests). Further, DTC tests can reduce cost and expand access to care in countries with limited resources and can support healthcare systems in extraordinary circumstances such as a pandemic. Valid concerns about DTC testing need to be described, addressed and resolved with the help of authorities and regulators in collaboration with HCP and should not detract from the advantages DTC tests can provide. HCP should play a more prominent role in educating the public through mass media and social media on the proper use of DTC tests and help to pinpoint problem areas.

Online seminars as an information source for direct-to-consumer stem cell therapy.

Aim: To attend stem cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online 'webinars' to determine accuracy and regulatory oversight of the advertised SC therapies. Methods: The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion: None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.