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FDA approves at-home test kits for inherited cancer: how useful are they?
https://www.facingourrisk.org/XRAY/fda-approves-dtc-testing
Full article: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm
Genetic testing for health conditions (such as risk for cancer) typically requires a prescription from a doctor. Until recently, direct-to-consumer (DTC) genetic testing has focused on tests to learn your ancestry and find of unknown branches of family trees. A laboratory called 23andMe that provides direct-to-consumer genetic testing has been given FDA approval to report results for 3 mutations found in the BRCA1 and BRCA2 genes. The FDA statement provides details about this approval and warns people about the limitations of the 23andMe test. (03/19/18)
Expert Guidelines
NCCN guidelines recommend genetic counseling and testing for people without cancer who have the following family history:
- A relative who has tested positive for an inherited mutation in a gene that increases cancer risk.
- One or more first- or second-degree relatives with breast cancer and any of the following:
- diagnosed at age 45 or younger
- triple-negative breast cancer
- two separate breast cancers, with the first diagnosis at age 50 or younger
- male breast cancer
- One or more first- or second-degree relatives with:
- colorectal cancer before age 50
- endometrial cancer before age 50
- ovarian, fallopian tube, primary peritoneal cancer
- rare or childhood cancers
- One or more first-degree relatives with:
- metastatic or high-grade prostate cancer
- pancreatic cancer
- Two or more relatives on the same side of the family diagnosed with any combination of the following at any age:
- breast cancer
- pancreatic cancer
- prostate cancer
- melanoma
- sarcoma
- adrenal cancer
- brain tumors
- leukemia
- endometrial cancer
- thyroid cancer
- kidney cancer
- diffuse gastric cancer
- colon cancer
Questions To Ask Your Health Care Provider
- Given my personal and family history, will this test be informative?
- Are there other options for genetic testing? How do they compare to this test?
- If I test negative, should I consider further genetic testing?
- If I test positive, what is my cancer risk? What preventative measures could I consider? Should I consider different treatment options?
- Should I share my 23andMe results with my relatives? Which ones?
- Can you refer me to a genetic counselor?
Open Clinical Trials
Below are clinical trials that include genetic counseling and testing.
Other genetic counseling or testing studies may be found here.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.