Federal Bureau of Investigation (FBI) agents searched uBiome headquarters on 26 April, reportedly investigating questionable billing practices, according to the Wall Street Journal. The California Department of Insurance is also conducting an investigation into billing practices at the microbiome startup. uBiome uses machine learning and high-throughput sequencing of the 16s ribosomal gene in bacterial DNA to profile the gut and vaginal microbiome and provide information with clinical utility. The tests identify microbial species purported to correlate with irritable bowel syndrome, chronic fatigue, diarrhea, weight gain and other conditions. Before the FBI raid, uBiome had already accumulated 28 complaints filed between 2017 and 2019 with the Federal Trade Commission. These complaints, revealed through a Freedom of Information Act request, included a person billed for a test taken by their spouse; after flagging the mistake, the couple were charged about $3,000 more for a test they never took. Another customer was billed over $2,000 after the insurance company covered only part of the costs.
uBiome was founded in 2012 with $350,000 from a crowdfunding campaign and later raised up to $105 million from investors. The biotech launched SmartGut and SmartJane, doctor-ordered sequencing tests for the gut and vaginal microbiomes, respectively, that are intended to be covered by insurance, and a Gut Explorer kit, which is available directly to the public online at $89. On 1 May uBiome founders Zac Apte and Jessica Richman were placed on leave, and five days later uBiome withdrew SmartGut and SmartJane.
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FBI raids Silicon Valley microbiome startup. Nat Biotechnol 37, 574 (2019). https://doi.org/10.1038/s41587-019-0153-8