The FBI recently raided the offices of uBiome Inc. in San Francisco, US. Since then, the company’s co-founders have been placed on administrative leave and uBiome has temporarily suspended their clinical operations.

The FBI raid of uBiome’s offices is reportedly due to an ongoing investigation into their billing practices, with customers complaining that uBiome overbilled their insurance company without their consent. Additionally, there are also reports that uBiome pressured doctors into approving its tests in order to drive aggressive growth in their number of billable samples.

Microbiome home testing

The concept behind uBiome’s SmartGut product is an intriguing one. The company uses sequencing technology coupled with machine learning and artificial intelligence to identify which micro-organisms are present in a patient’s gut. SmartGut is designed to help patients suffering from gut-related conditions such as irritable bowel syndrome (IBS), ulcerative colitis, and Crohn’s disease.

While the SmartGut test is not approved by the US Food and Drug Administration (FDA), it is able to be used for clinical purposes in the US due to the fact that it is performed by a CLIA-licensed and College of American Pathologists-accredited laboratory.

The SmartGut test is provided via an in-home testing kit, making it easy to use. Until recently, this test could be prescribed by physicians and was also sold online directly to consumers. Kits sold direct-to-consumer still need to be signed off by a doctor and uBiome works with a network of physicians to enable this process.

It has been suggested that identifying and characterising the micro-organisms present in a patient’s gut may provide insights into a patient’s health, as well as underlying causes of gastrointestinal symptoms. Currently, however, there is insufficient scientific evidence to prove that the SmartGut test provides patients with real clinical benefit. US health insurers have also noted a lack of clinical outcome studies using the SmartGut product and are thus labelling this device “experimental” or “investigational.”

Another concern that has been raised is the fact that these types of microbiome tests are not standardised, meaning test results can be heavily skewed by differences in key steps of the sample preparation, such as DNA extraction, or data analysis. As a result, individuals may receive dramatically different results depending on the provider from whom they have purchased their test.

While the future of uBiome’s SmartGut product currently appears uncertain, there is clearly a demand for microbiome testing among the general population.

The rising popularity of direct-to-consumer genetic testing means that an increasing number of health-based startups are being formed, especially in the US. It, therefore, seems likely that some form of microbiome testing will remain on the market, although whether these tests will continue to be reimbursed remains to be seen. Rather, it may well be that future customers are forced to pay for these tests out of pocket.