Direct-to-consumer (DTC) genetic testing is a
type of genetic test that is accessible directly to the consumer without having
to go through a health care professional. In clinical practice, the health care
professionals are the ones requesting for genetic testing and obtain informed
consent of the patient. However, for some genetic tests, consumers can obtain
such a test themselves. They only have to collect a sample of their saliva in the
provided test tube and send it to the DTC-GT company where the laboratory will
analyze their DNA. There are a variety of DTC tests, including testing for
breast cancer alleles to mutations linked to cystic fibrosis. Although the
companies who develop and sell the DTC-GTs promote these tests with slogans
like ‘to empower you with genetic insights to
help motivate you to improve your health’, it is not expected that consumers
themselves can correctly interpret the complex results. In genetic testing, the
results are usually expresses as ‘risks’ to certain diseases or disorders and
not a simple ‘yes or no’ outcome. In addition, these GT should be fully
validated so as not to provide false-positive or false-negative results.
It is therefore not strange that consumers
who have bought a DTC-GT then consult their physician for her/him to interpret the
results. This provides the primary-health care physicians with quite a few dilemmas.
First of all they themselves should be able to understand the type of test
performed, the presented outcome and any possible consequences for the patient,
which is not usual for non-geneticists. Secondly, they have to make sure the
test results are valid and might have to order additional tests though the
regular health care system. Thirdly, if the results indicate a high risk for a
certain disease but possibly also for other diseases, is the physician obliged
to report this to the patient who might not wanted to know this. So DTC-GT also
put a burden on the physicians who have the moral obligation to inform
patients, to treat them and to protect patient confidentiality.
As the prices of these DTC-GTs are
expected to drop (DNA test are currently available for $99), physicians can
expect an increase in patients who not only googled their symptoms, but might
have gone an extra step and requested genetic testing. Canadian researcher Gillian Bartlett
of the Department of Family Medicine of the McGill University in Montreal
therefore urgently asks to develop best practice recommendations and identify
the ethical, legal and social implications of DTC-GT.
The FDA has recently requested that
several companies refrain
from providing direct to consumer tests with health-related results, as
they have not approved these tests yet.
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