Pitfalls and perils from FDA-approved germ-line cancer predisposition tests.

The FDA approval on September 29, 2023, for "class III de novo" blood tests to assess hereditary cancer risk make widely available tests that may be obtained through a Direct to Consumer (DTC) path. There is concern that germ-line predisposition tests may not be reimbursed by insurance adding financial burdens to individuals and families. It is generally agreed in the fields of oncology and genetics that germ-line testing for disease susceptibility including cancer is best performed under care of a healthcare provider with genetic counseling. Our recommended cautions and call for change may seem paternalistic to some and may appear to infringe upon constitutional rights as they may relate to DTC, but there is a real concern with harm from germ-line testing of both adults and minors that can occur through DTC tests. The DTC option of germ-line testing for cancer susceptibility should be discouraged given the risks of anxiety, lack of adequate interpretation for variants not strongly associated with cancer, potential for minors to be tested outside the healthcare system and potential for loss of follow-up if test results are not shared with health care professionals or never make it into the medical record. The FDA should consider clear unambiguous guidance when it comes to germ-line DTC testing for cancer susceptibility for adults and especially for minors.