Veritas
This case study involves the ethical concerns of Direct-to-Consumer (DTC) genetic testing at Veritas Diagnostics, Inc. (VDI) from the perspective of an Ethics Officer. There are a number of recommendations that I have for VDI that will serve to protect its standing as a reputable, quality, and ethical company with this roll-out of DTC genetic testing, all of which I will discuss independently starting with legal requirements surrounding this industry.
There are some federal, international, and state laws that address DTC genetic testing that we must review and adhere to where applicable. None of these laws are “crystal clear”, but nonetheless do provide some guidance as to how DTC genetic testing should be offered to the public. The Federal Trade Commission (FTC) is responsible on a federal level to protect consumers from deceptive marketing and advertising, but have not thus far enacted any public policy on DTC genetic testing kits other than regulating lab created kits (what they call medical devices) insofar as the DTC company must undergo premarket review prior to the product being marketed. The United States and Europe both have laws in place that prevent false advertisements on a variety of consumer products, but there have not yet been any specific laws passed pertaining to DTC genetic tests specifically. On the state level DTC genetic testing is actually illegal in some states, such as New York and California, and they have served cease and desist letters to several DTC companies. Being so, our website must clearly state that consumers from these states and others like them are not permitted to purchase our DTC testing kits, and further to that, we must have measures in place to not mail any kits to addresses in those states. We also must be aware of our advertising campaigns and stay away from making false claims of testing utilities as other companies in our industry have not. An example of this is a DTC company, Myriad, that has been involved in
There are some federal, international, and state laws that address DTC genetic testing that we must review and adhere to where applicable. None of these laws are “crystal clear”, but nonetheless do provide some guidance as to how DTC genetic testing should be offered to the public. The Federal Trade Commission (FTC) is responsible on a federal level to protect consumers from deceptive marketing and advertising, but have not thus far enacted any public policy on DTC genetic testing kits other than regulating lab created kits (what they call medical devices) insofar as the DTC company must undergo premarket review prior to the product being marketed. The United States and Europe both have laws in place that prevent false advertisements on a variety of consumer products, but there have not yet been any specific laws passed pertaining to DTC genetic tests specifically. On the state level DTC genetic testing is actually illegal in some states, such as New York and California, and they have served cease and desist letters to several DTC companies. Being so, our website must clearly state that consumers from these states and others like them are not permitted to purchase our DTC testing kits, and further to that, we must have measures in place to not mail any kits to addresses in those states. We also must be aware of our advertising campaigns and stay away from making false claims of testing utilities as other companies in our industry have not. An example of this is a DTC company, Myriad, that has been involved in