Microbiome-testing company uBiome has suspended its medical tests following an FBI raid

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Microbiome-testing company uBiome has suspended its clinical tests, the company told customers on Monday.
The suspension comes following an FBI raid of the company’s offices in San Francisco. UBiome’s co-CEOs Jessica Richman and Zac Apte were placed on administrative leave as well.
The company has stopped selling its SmartGut and SmartJane tests.
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Microbiome-testing company uBiome told customers on Monday that it had suspended the sale and testing of two of its main tests, after an FBI raid on the company’s headquarters.

In late April, the FBI reportedly raided the company’s offices in San Francisco as part of an investigation into uBiome’s billing practices. Following the raid, uBiome’s cofounders and co-CEOs Jessica Richman and Zac Apte were placed on administrative leave.

UBiome sells tests that sequence the microbiome, which is the assortment of bacteria and other microbes that live in our bodies. To date, the company has raised $105 million from investors.

The company’s offerings include doctor-ordered tests called SmartJane, which looks at the vaginal microbiome to test for sexually transmitted diseases and chronic vaginal infections, and SmartGut, which looks at the gut microbiome to test for gut conditions and metabolic disorders. The company stopped selling those tests, and won’t evaluate any that have been sent in recently. UBiome also said it would refund customers’ for canceled tests.

"At this time and until further notice, uBiome will not be offering SmartGut or SmartJane," the company said in an email to customers. "We will not be releasing clinical reports, processing samples, billing health insurance, or shipping new collections kits."

UBiome also sells a direct-to-consumer test that doesn’t require a prescription called the "Explorer" test. That test is still offered.

UBiome did not immediately return a request for comment.

The company named John Rakow, its general counsel, as interim CEO and said in a news release on Wednesday that it plans to undertake an independent investigation overseen by its board into the company’s billing practices.

Here’s the full email, which Business Insider received because we’ve taken the Explorer test:

On Friday, April 26, 2019, federal authorities, pursuant to a search warrant, searched uBiome’s facilities in San Francisco. We are cooperating fully with federal authorities on this matter.

Our Board of Directors has appointed John Rakow, our General Counsel, as Interim CEO of uBiome, effective immediately.

Our Co-CEOs, Jessica Richman and Zac Apte, are currently on administrative leave as we conduct an independent investigation into the company’s billing practices, to be overseen by a Special Committee of the Board. Once complete, we will take any corrective actions that are needed to ensure we can become a stronger company better able to serve patients and healthcare providers.

We will also be temporarily suspending clinical operations. At this time and until further notice, uBiome will not be offering SmartGut or SmartJane. We will continue to offer and process our Explorer product.

It is important to reiterate that this is a suspension. This does not mean we will not offer clinical products in the future, nor does this insinuate a lack of value or utility in our products. There is significant clinical evidence that demonstrates the utility and value of uBiome’s products as important tools for patients, healthcare providers, and our commercial partners. We look forward to continuing to demonstrate this clinical utility and value.

Any SmartGut or SmartJane request or order that is pending on your account has been canceled. If you made any out of pocket payment upfront, this will be refunded to you within 3-5 business days. We will not be releasing clinical reports, processing samples, billing health insurance, or shipping new collections kits, at this time. If you would prefer that any of your pending samples be destroyed, simply reply to this email. Our team will ensure this is taken care of for you expeditiously.

Thank you for your interest in our clinical products and your support of our company. If you have any further questions or concerns, contact us at support@ubiome.com or reply to this email.

The uBiome Team

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