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www.fdanews.com/articles/212934-social-emotional-risks-associated-with-multi-cancer-screening-discussed-by-adcomm

Social, Emotional Risks Associated With Multi-Cancer Screening Discussed by Adcomm

December 4, 2023

Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the social and emotional risks the technology might carry.

The panel met to discuss several topics, including the risk and benefits associated with MCDs when used to screen asymptomatic individuals who may benefit from earlier detection. While traditional cancer screening tests have been specific to a single cancer indication, these technologies are intended to detect multiple cancers at once.

One overriding risk associated with the tests is the chance of false positive and false negative results. Committee members, as well as patient representatives cited the need to manage the patient’s expectations.

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