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.
- NCT02665195: Prospective Registry Of MultiPlex Testing (PROMPT). PROMPT is an online research registry. The goal of PROMPT is to help researchers to better understand the risks that are linked to mutations in less well-studied genes.
- NCT04245176: Genetic Testing for All Breast Cancer Patients (GET FACTS). This study looks at the impact of a novel genetic counseling method on surgical decisions in people with newly diagnosed breast cancer. This study involves genetic counseling about contralateral breast cancer risk.
- NCT02620852: WISDOM Study: Women Informed to Screen Depending on Measures of Risk offers women age 40-74 the opportunity to undergo risk assessment and genetic testing in order to determine the best breast screening options based on their situation.
- Enhancing Genetic Risk Assessment in Underserved Blacks and Latinas at Risk of Hereditary Breast Cancer. This study will test how well educational materials increase the use of knowledge about hereditary cancer risk.
- NCT04476654: Improving Uptake of Genetic Cancer Risk Assessment in African American Women-Video. This study looks at the usefulness of intervention with a culturally-tailored video to improve uptake of genetic counseling in Black women who are at increased risk of HBOC.
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.