A start-up selling health tests, uBiome confirmed on Monday that it has informed its customers via email, that clinical operations of health tests are being suspended, including SmartJane and SmartGut.
The decision appears to be followed by FBI’s search at the San Francisco offices of the company, as a part of investigation of the billing practices of the start-up.
The company specified Explorer would continue to be sold directly to consumers. The company said that recent SmartJane or SmartGut tests stand cancelled, and refunds would be provided for tests that were paid out of the pocket.
For many months prior to FBI’s search, uBiome often billed insurance more than once for their tests, without obtaining patient consent.
The company said last week that ZacApte and Jessica Richman, founders of the company, have taken ‘administrative leave,’ and the firm’s general counsel John Rakow has been named CEO interim. The company’s board said that it too would conduct an investigation independently into the billing practices of uBiome, following which, as the email stated, they intend to come out as a stronger organization, better equipped to serve healthcare.
In the email, uBiome says their clinical operations have only been temporarily suspended. In the future, they do intend to offer their clinical products, and the suspension should not insinuate the value of their products. Clinical evidence shows the value and utility of their products, and Biome looks forward to continue demonstrating such clinical value and utility.
The email also clearly conveyed that any pending orders for the company’s SmartJane or SmartGut products were cancelled, and any payment made out of the pocket would be refunded in 3-5 days. During this time, uBiome would neither release any clinical reports, process samples or bill health insurance; nor would they ship new collections packets. In case customers preferred any of their pending samples be destroyed, they were to reply to the company’s email in anticipation of it being acted upon expeditiously. uBiome were unwilling to share their comments about the email.