Test type

Cancer predisposition tests: what FDA reviews

For people who want to know: my inherited cancer risk.

What FDA says

FDA reviews before sale

FDA: “These tests provide information about an individual's risk of getting certain types of cancer.” (U.S. Food and Drug Administration)

FDA's database shows four decisions under this product code, listed below. Two concern the same BRCA1/BRCA2 report: a 2018 De Novo grant for three variants and a 2023 510(k) clearance for 44.

FDA's page on review:

These tests are considered moderate to high risk and are required to come to FDA for premarket review and clearance.

FDA records under product code QAZ: four.

• 23andMe: BRCA1/BRCA2, three selected variants

  DEN170046 · De Novo request granted Mar 6, 2018 · 23andMe

  Breast cancer risk (BRCA1/BRCA2); Ovarian cancer risk (BRCA1/BRCA2); Prostate cancer risk (BRCA1/BRCA2)

• 23andMe: MUTYH-associated polyposis

  K182784 · 510(k) cleared Jan 18, 2019 · 23andMe

  Colorectal cancer risk (MUTYH-associated polyposis)

• 23andMe: Hereditary prostate cancer (HOXB13)

  K211499 · 510(k) cleared Jan 6, 2022 · 23andMe

  Prostate cancer risk (HOXB13)

• 23andMe: BRCA1/BRCA2, 44 selected variants

  K223597 · 510(k) cleared Aug 31, 2023 · 23andMe

  Breast cancer risk (BRCA1/BRCA2); Ovarian cancer risk (BRCA1/BRCA2); Prostate cancer risk (BRCA1/BRCA2); Pancreatic cancer risk (BRCA1/BRCA2)

The federal rule

FDA classifies these tests under 21 CFR 866.6090, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing any types of cancer.” (21 CFR 866.6090)

What every home DNA result has in common

FDA: “No test is 100% accurate.” (U.S. Food and Drug Administration) MedlinePlus adds that “additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions.” (MedlinePlus)

Federal rules for genetic health risk tests note that “some people may feel anxious about getting genetic test health results. This is normal.” (21 CFR 866.5950)

Other test types

• Carrier screening: exempt from premarket notification, with conditions (FDA's wording and conditions are on that page)
• Genetic health risk: first test reviewed; later tests exempt, with conditions (FDA's wording and conditions are on that page)
• Pharmacogenetics: FDA reviews before sale (FDA's wording and conditions are on that page)
• Ancestry: not reviewed by FDA (FDA's wording and conditions are on that page)
• Wellness and traits: generally not reviewed by FDA (FDA's wording and conditions are on that page)