Bankrupt poop-testing startup uBiome just lost the government approval that's required to run key tests
Silicon Valley microbiome-testing startup uBiome filed for bankruptcy earlier this month after months of challenges and setbacks. Now, a uBiome spokesperson confirmed that uBiome no longer has the lab certification required to run clinical tests. uBiome once convinced Silicon Valley that testing poop was worth $600 million, but insiders previously told Business Insider they questioned the validity of the science behind its products. Click here for more BI Prime stories.
uBiome, the poop-testing startup under a federal probe that filed for bankruptcy earlier this month, no longer has the lab certification required to run clinical tests. Those tests previously made up two of its three tests. The company suspended them on the heels of an FBI investigation. Then, uBiome filed for bankruptcy and said it would focus on its last remaining test, a consumer product called Explorer. uBiome once convinced Silicon Valley that testing poop was a $600 million business. The company focuses on the the diverse community of bacteria in our bodies known as the microbiome. uBiome's valuation depended heavily on the idea that its products could be considered health tools and could be used to guide medical decisions. Its last remaining test, the Explorer, is instead pitched as a fun way to get a better understanding of what's going on in your gut, but uBiome says it shouldn't be used to make medical decisions. Read more: uBiome convinced Silicon Valley that testing poop was worth $600 million. Then the FBI came knocking. Here's the inside story. A spokesperson from the Centers for Medicare and Medicaid Services, which governs laboratories, and a spokesperson from uBiome each confirmed to Business Insider that the company no longer maintained the certificate. uBiome continues to display the certificate for the program, known as CLIA, on its website. The CLIA rules stand for Clinical Laboratory Improvement Amendments and are designed to ensure that laboratories meet standards of cleanliness and reliability appropriate for healthcare. The uBiome spokesperson said uBiome's CLIA license was removed automatically after uBiome suspended sales of its clinical tests, and added that the company will also be automatically withdrawn from its other lab certificate program, which is with the College of American Pathologists, or CAP. The spokesperson said uBiome planned to remove both icons from its website this week. Mounting challenges for a startup that once convinced Silicon Valley that testing poop was a $600 million business uBiome has faced a rocky and challenging few months, kicked off by an FBI raid that was reportedly related to its billing practices. As that probe has continued, uBiome has lost all of its top executives, laid off half of its staff, and faced serious questions about the scientific validity of its products. Most recently, the company filed for bankruptcy. This latest setback suggests that things are continuing to get worse for uBiome. Out of an initial offering of three products, the company has only one remaining. All three products, however, were built on a scientific dataset that insiders previously told Business Insider was flawed. That dataset was used as a reference for all of the health insights that uBiome provided. It was meant to reflect a healthy, adult microbiome. But it contained data gleaned from poop samples that were taken from 45 minors and at least one non-human, company representatives confirmed to Business Insider in August. Read more: uBiome insiders say key science at the buzzy startup was flawed from the start. Now, the company and a top science journal are investigating. Outside experts told Business Insider there were other problems with uBiome's tests as well. For example, one-time poop samples like the kind uBiome analyzed simply are not comprehensive enough to provide people with real health insights, they said. Plus, the patient history that uBiome collected was based on the honor system, meaning some people in uBiome's dataset that were assumed to be healthy may have, in fact, been sick. That could throw off uBiome's analysis and render its insights less meaningful, the experts said.DON'T MISS: uBiome convinced Silicon Valley that testing poop was worth $600 million. Then the FBI came knocking. Here's the inside story. SEE ALSO: uBiome insiders say key science at the buzzy startup was flawed from the start. Now, the company and a top science journal are investigating. Join the conversation about this story » NOW WATCH: If humans gave birth in space, babies would have giant, alien-shaped heads
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