Pitfalls of FDA-approved germline 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”
2024-12-30
(Press-News.org)
“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.”
BUFFALO, NY – December 30, 2024 – A new editorial was published in Oncotarget’s Volume 15 on December 24, 2024, titled “Pitfalls and perils from FDA-approved germ-line cancer predisposition tests.“
Authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi from Brown University, the article highlights concerns about the risks of a newly approved genetic test for cancer risk. This test, called the “Invitae Common Hereditary Cancers Panel,” was approved in 2023 and examines 48 genes linked to inherited cancers, including breast, ovarian, and Lynch syndrome-related cancers. Although the test increases access to genetic information, the authors warn that using it without professional guidance may lead to confusion, stress, and potential harm.
One concern is that people can order this test online without consulting healthcare professionals or genetic counselors. Without expert help, users might struggle to understand their results especially if they indicate risks that are unclear or difficult to act on. This can cause unnecessary anxiety and confusion.
“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 editorial also points out ethical and medical issues when minors use these tests. If a child’s test is done without medical oversight, results might not be added to their health records, making follow-up care harder to manage and potentially risking their long-term health.
Cost is another issue. These tests are often not covered by insurance, which can place a financial burden on families who might need additional testing or medical advice.
The researchers emphasize that genetic testing for cancer risk should always include healthcare providers and genetic counseling. This ensures users fully understand their results and receive proper guidance. The authors also call on the US Food and Drug Administration (FDA) to provide clear rules for using these tests, particularly for minors.
In conclusion, while genetic testing holds great potential for improving cancer prevention and care, its benefits must not come at the cost of safety and public health. Responsible use of these tests will require collaboration between regulators, healthcare professionals, and testing companies to address the risks and ensure these tools are used effectively.
Continue reading: DOI: https://doi.org/10.18632/oncotarget.28677
Correspondence to: Wafik S. El-Deiry – wafik@brown.edu
Keywords: cancer, cancer predisposition, germline, marketing authorization, hereditary cancer, direct to consumer
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About Oncotarget:
Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science.
Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science).
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[Press-News.org] Pitfalls of FDA-approved germline 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”
