Carrier screening · De Novo DEN140044
23andMe: Bloom syndrome carrier status
FDA record DEN140044: De Novo request granted on February 19, 2015 for 23andMe. It is one of the four tests on FDA's own Direct-to-Consumer Tests table.
- FDA device name
- 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
- Applicant (as FDA lists it)
- 23AndMe
- FDA decision
- De Novo request granted
- Decision date
- February 19, 2015
- Product code
- PKB
- Regulation
- 21 CFR 866.5940
FDA database entry · FDA decision summary (PDF) · openFDA record
What the authorization says it may report
This test can be used to determine carrier status for Bloom syndrome in adults of reproductive age, but cannot determine if a person has two copies of the BLMAsh variant.
The test is most relevant for people of Ashkenazi Jewish descent.
Stated limitations
This test is not intended to diagnose a disease, to tell you anything about the health of your fetus, or your risk or your new born child’s risk of developing a particular disease later on in life.
The probability that the laboratory cannot process the sample can be up to 7.6%.
FDA classifies this test type under 21 CFR 866.5940, which says: “Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.” (21 CFR 866.5940)
What this record doesn't tell you
An FDA record says what a test was authorized to report on the decision date. It doesn't say whether the product is still sold, what it costs, or which version a kit in a store uses. Check the company's own label and report for the current claims.
FDA's general advice on direct-to-consumer tests: “Do not make any dietary or health-related decisions without first discussing your test results with your health care provider.” (U.S. Food and Drug Administration)