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uBiome, Inc.
Company typePrivate
IndustryBiotechnology
Founded2012
FounderZachary Apte, Jessica Richman
Defunct2019
FateBankruptcy in 2019 after federal fraud charges in 2021. Founders are FBI fugitives.
Headquarters
San Francisco, California
,
United States
Products
  • SmartGut
  • SmartJane
  • Explorer
Websiteubiome.com (archived link)

uBiome, Inc. was a biotechnology company based in San Francisco that developed technology to sequence the human microbiome. Founded in 2012, the company filed for bankruptcy in 2019 following an FBI raid in an investigation over possible insurance fraud[1][2] involving the US health insurance program Medicare.[3]

In 2021, the Securities and Exchange Commission charged two of the cofounders (Richman and Apte) with defrauding investors.[4][5] The couple were also charged with federal crimes including conspiracy to commit fraud and money laundering.[6] Since 2021, the FBI has considered the founders to be fugitives.[7][8]

History

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Founding

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The company was founded by Jessica Richman, Zachary Apte, and Will Ludington who were scientists in the California Institute for Quantitative Biosciences.[9] In November 2012, uBiome generated $350,000 through a crowdfunding campaign.[10] The founders received mentoring and funding from Y Combinator and further funding from Andreessen Horowitz and 8VC.[11][12][13]

Jessica Richman was also found to have lied about her age to get on tech lists such as Forbes 30 under 30. She was in her forties at the time.

Insurance fraud investigation and liquidation

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In April 2019, FBI agents raided the uBiome office in an investigation over possible insurance fraud[1][2] involving the US health insurance program Medicare.[3] According to company insiders, the company often repeatedly billed patients without their consent and pressured doctors to approve tests.[14]

Cofounders Apte and Richman were put on administrative leave pending an investigation by the company's board.[15]

The company filed for Chapter 11 bankruptcy (reorganization of debt) in September 2019, amidst the investigation,[16] and less than a month later it filed for a Chapter 7 bankruptcy (liquidation) and shut down.[3]

In 2021, the Securities and Exchange Commission charged two of the cofounders (Richman and Apte) with defrauding investors.[4][5] The couple were also charged with federal crimes including conspiracy to commit fraud and money laundering.[6] Richman and Apte married in 2019 and relocated to Germany in June 2020. Since 2021, the FBI has considered them to be fugitives.[7]

Products and services

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Customers purchase kits to sample one or more parts of their body, including the gut, genitals, mouth, nose, or skin. After swabbing, a participant takes a survey which is used to make correlations with microbiome data. The participant sends the kit to the company in the mail and receives data in a few weeks; they can compare their data with that of uBiome's data set.[17][18] In 2015 uBiome received Clinical Laboratory Improvement Amendments (CLIA) certification from the State of California.[19] In 2016, uBiome received accreditation from the College of American Pathologists.[20]

Technology

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As of 2015, the company first amplified a portion of the bacterial gene that encodes 16S ribosomal RNA using PCR, then sequenced the amplified 16S ribosomal RNA gene, in order to categorize the bacteria at the genus level.[21] The company had proprietary machine learning algorithms that analyzed the sequence data and compared it with the company's proprietary database of microbiomes, built from the samples that partners[clarification needed] and single[clarification needed] customers sent to them, and web-based software that allowed individuals to view their microbiome and make certain comparisons.[22][23] A 2014 report in Xconomy said the company outsourced the sequencing.[23] The sequencing was done on the Illumina NextSeq500 sequencer.[24][25]

In October 2015 the company introduced an app on iOS using ResearchKit that allowed customers to view their results on mobile devices.[26]

uBiome has been compared with Theranos and 23andMe, each of which was also a biotechnology company influenced by Silicon Valley.[27][28]

Citizen science

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Amy Dockser Marcus noted in a 2014 essay in The Wall Street Journal that when uBiome raised its initial round of crowdfunding in early 2013, many questions were raised by bioethicists about the company's citizen science business model — namely whether it had actually obtained informed consent from its customers, and whether direct to consumer genetic testing initiatives could be ethically conducted at all, and its lack of institutional review board (IRB) approval.[29][30][31] The Wall Street Journal essay also noted that questions were raised about the quality of data obtained in citizen science initiatives, with regard to self-selection and other issues.[29][32]

The company obtained an institutional review board approval in July 2013.[29][33][34]

In 2014, people experienced in biotechnology entrepreneurship also raised questions about the ethics of crowdfunding a biotech company, as the risks of such ventures are high even for people with scientific and business sophistication.[29][35]

As of 2015, uBiome offered a $1 million grant program to researchers and citizen scientists for microbiome sampling and related analysis.[36] One winner of the first round of such grants was the Centers for Disease Control and Prevention.[27]

Awards and recognition

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In March 2018, uBiome made Fast Company's list for The World's Most Innovative Companies in Data Science, acknowledging uBiome's work collecting data to develop tests for HPV and STIs.[37]

See also

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References

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  1. ^ a b Shin, Sally (April 26, 2019). "uBiome office in San Francisco getting raided by FBI San Francisco division special agents Video from @ltbatch on the ground pic.twitter.com/GO4Sb2LFMO". @sallyshin. Retrieved April 26, 2019.
  2. ^ a b Mathews, Anna Wilde; Marcus, Amy Dockser (April 26, 2019). "FBI Searches Microbiome Testing Startup in Billing Probe". Wall Street Journal. ISSN 0099-9660. Retrieved April 26, 2019.
  3. ^ a b c "uBiome to Close Doors One Month After Bankruptcy Filing". BioSpace. October 2, 2019. Retrieved March 9, 2021.
  4. ^ a b SFGATE, Katie Dowd (March 21, 2021). "SF couple who ran trendy poop-testing startup charged with fraud". SFGATE. Retrieved March 23, 2021.
  5. ^ a b "SEC.gov | SEC Charges Co-Founders of San Francisco Biotech Company With $60 Million Fraud". www.sec.gov. Retrieved March 23, 2021.
  6. ^ a b Morse, Jack (March 22, 2021). "Turns out that poop-testing startup was full of it". Mashable. Retrieved March 23, 2021.
  7. ^ a b Dockser Marcus, Amy (November 24, 2021). "The Biotech Startup That Became an FBI Target". Wall Street Journal (podcast). Retrieved April 3, 2022.
  8. ^ "Founders of poop-testing uBiome, reportedly on the run, charged by SEC with defrauding investors". Endpoints News. Retrieved February 4, 2023.
  9. ^ Lee, Teresa (April 22, 2013). "Swabbing for Science". The Berkeley Science Review. Archived from the original on October 29, 2016. Retrieved October 29, 2016.
  10. ^ Vachelard, J; Gambarra-Soares, T; Augustini, G; Riul, P; Maracaja-Coutinho, V (February 17, 2016). "A Guide to Scientific Crowdfunding". PLOS Biology. 14 (2): e1002373. doi:10.1371/journal.pbio.1002373. PMC 4757556. PMID 26886064.
  11. ^ Chokkattu, Julian. "uBiome Raises $4.5M From Angel Investors, Andreessen Horowitz To Crowdsource Microbiome Research". TechCrunch.
  12. ^ Dillet, Romain. "Andreessen Horowitz Raises Massive New $1.5 Billion Fund". TechCrunch.
  13. ^ Buhr, Sarah. "Gut health startup uBiome has raised $15.5 million and is launching a DNA test for your poop". TechCrunch.
  14. ^ Farr, Christina (May 2, 2019). "Insiders describe aggressive growth tactics at uBiome, the health start-up raided by the FBI last week". CNBC. Retrieved March 9, 2021.
  15. ^ Farr, Christina (May 6, 2019). "Health tech start-up uBiome suspends clinical operations following FBI raid". CNBC. Retrieved June 18, 2019.
  16. ^ "Everything we know about uBiome, the startup that convinced Silicon Valley that testing poop was worth $600 million, and then filed for bankruptcy amid an FBI investigation". Business Insider. Retrieved May 10, 2020.
  17. ^ Gertner, Jon (January 7, 2015). "What's Lurking In Your Microbiome? Possibly, A Cure For Disease". Fast Company.
  18. ^ Almalki, M; Gray, K; Sanchez, FM (February 24, 2015). "The use of self-quantification systems for personal health information: big data management activities and prospects". Health Information Science and Systems. 3 (Suppl 1 HISA Big Data in Biomedicine and Healthcare 2013 Con): S1. doi:10.1186/2047-2501-3-S1-S1. PMC 4437547. PMID 26019809.
  19. ^ "uBiome Launches CLIA Lab". genomeweb. April 28, 2015.
  20. ^ Taylor, Julie (October 4, 2016). "uBiome's Laboratory Receives Accreditation by College of American Pathologists (CAP)". PRWeb.
  21. ^ Scoles, Sarah (October 7, 2015). "I Sent a Sample of My Poop to uBiome -". The Crux @ Discover Magazine. Archived from the original on October 29, 2016. Retrieved October 29, 2016.
  22. ^ Khamsi, Roxanne (July 17, 2014). "Can Gut DNA Sequencing Actually Tell You Anything About Your Health?". Newsweek. Retrieved March 21, 2015.
  23. ^ a b Tansey, Bernadette (August 18, 2014). "Glowing Plants To Nanodiamonds: Y Combinator's Biotechs Debut". Xconomy.
  24. ^ "ubiome 0.5.8 : Python Package Index". testpypi.python.org. June 17, 2016. Retrieved October 29, 2016.
  25. ^ Mac, Tracy (June 2, 2015). "Interview with Jessica Richman of uBiome". The Power of Poop.
  26. ^ Taylor, Nick Paul (October 11, 2015). "UBiome taps Apple ecosystem to broaden microbiome data-gathering drive". FierceBiotech.
  27. ^ a b Zhang, Sarah. “Microbiome Startup uBiome Will Sequence Poop for the CDC.” Wired. Nov. 30, 2015 Quote: "Recent controversy over the blood testing company Theranos has highlighted the sometimes loose regulations, and the Food and Drug Administration has it wants to regulate lab tests more strictly"
  28. ^ Leonard, Andrew (December 22, 2015). "Silicon Valley Will See You Now". Modern Luxury: Silicon Valley. But a healthy dose of skepticism is also in order, not least because of the difficulties faced by the two most-celebrated digital-health startups, 23andMe and Theranos....In 2013, the FDA banned 23andMe from marketing its Personal Genome Service. The FDA, which had yet to fully sign off on the technology, was concerned "about the public health consequences of inaccurate results from the PGS devices." The lesson for the rest of the digital-health industry was clear: Unless they're expressly permitted by the FDA, companies should not encourage consumers to make medical decisions based on the health data the companies provide. ...Theranos came out of the gate with an unprecedented bang.....Then, in mid-October, an earthquake hit that rocked not just Theranos but the entire digital-health community.
  29. ^ a b c d Marcus, Amy Dockser (October 24, 2014). "The Ethics of Experimenting on Yourself". Wall Street Journal.
  30. ^ DNLee (February 22, 2013). "On Ethics and Self-Policing in (Citizen) Science". Scientific American Blog Network.
  31. ^ Chorost, Michael (September 23, 2013). "Crowdsourced Research Delves, Uncertainly, Into the Human Microbiome". The Chronicle of Higher Education.
  32. ^ Hall, Harriet (June 25, 2013). "Meet Your Microbes: uBiome Offers New Service". Science-Based Medicine.
  33. ^ Stone, Judy. "uBiome: Ethical Lapse or Not?". Scientific American. Retrieved February 9, 2015.
  34. ^ Jessica, Richman; Apte, Zachary (July 22, 2013). "Crowdfunding and IRBs: The Case of uBiome". Scientific American Blog.
  35. ^ Lee, Stephanie M. (February 15, 2014). "Biotech startup turns to crowdfunding". San Francisco Chronicle.
  36. ^ "FACT SHEET: Announcing the National Microbiome Initiative" (PDF). obamawhitehouse.archives.gov. The White House. May 13, 2016.
  37. ^ "The 2018 Top 10 Most Innovative Companies by Sector: Data Science | Fast Company". Fast Company. Retrieved March 26, 2018.
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