The FDA issued a safety communication today on the risk that biotin supplements “can significantly interfere with certain lab tests and cause incorrect test results”. The FDA communiqué mentions an increase in reported adverse events, and even one death, because of Biotin interference.
Biotin interferes with some lab tests and the FDA highlight the case where a patient died as a powerful warning – the individual was taking high dose Biotin and failed a blood test for cardiac troponin to diagnose heart attack. There are many Biotin containing supplements on the market and anyone who’s done a hybrid capture recently knows the importance of the biotin pull down! Although I should be clear that this is not a test type that the FDA mentions in their communication.
Biotin health supplements:
Why take Biotin and what is the clinical evidence? There are hundreds of dietary supplements promoted for hair, skin, and nailbenefits contain biotin levels up to 650 times the recommended daily intake of biotin. WebMD has some information suggesting an RDA of 6-35ug. A PubMed search for “biotin+health+supplement” returns just 47 results. However a Google search for the same terms returns 250,000 hits, loads of products available on the shopping pages and you can buy 12,000ug biotin supplements on Amazon for £10-15. Physicians may prescribe up to 300mg per day for multiple sclerosis.
Evidence is scant. The NaturallyCurly website has some anecdotes from users and there’s a whole load written on blogs and websites of people or companies selling Biotin supplements. But I found just one paper that went into much detail about the biological role of biotin and it’s potential benefits for TypeII diabetes.
A possible impact on ctDNA diagnostic testing?
Probably not…but the FDA ask labs developing tests that are using biotin to empirically determine the impact of biotin interference in their assays. As so many oncology tests are focussed on ctDNA hybrid capture using biotinylated probes there is a risk that high-level supplements could interfere but only if the biotin is carried through the DNA prep and downstream steps. This is most likely a very low risk…but something that it would be good for someone to prove!