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{{short description|Biotechnology company}}
{{Infobox company
| name = uBiome, Inc.
| type = [[Privately held company|Private]]
| foundation = 2012
| defunct = 2019
| fate = Bankruptcy in 2019 after federal fraud charges in 2021. Founders are FBI fugitives.
| founder = Zachary Apte, Jessica Richman
| location_city = [[San Francisco, California]]
| location_country = [[United States]]
| industry = [[Biotechnology]]
| owner =
| num_employees =
| homepage = [https://web.archive.org/web/20190416153433/http://ubiome.com/ ubiome.com] (archived link)
| footnotes =
| products = {{unbulleted list|SmartGut|SmartJane|Explorer}}
}}
{{lowercase title}}
{{use mdy dates|date=April 2022}}
'''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 [[Federal Bureau of Investigation|FBI]] raid in an investigation over possible insurance fraud<ref name=":1">{{Cite web |last=Shin |first=Sally |date=2019-04-26 |title=uBiome office in San Francisco getting raided by FBI San Francisco division special agents Video from @ltbatch on the ground pic.twitter.com/GO4Sb2LFMO |url=https://twitter.com/sallyshin/status/1121854424727425024 |access-date=2019-04-26 |website=@sallyshin |language=en}}</ref><ref name=":2">{{Cite news |last1=Mathews |first1=Anna Wilde |last2=Marcus |first2=Amy Dockser |date=2019-04-26 |title=FBI Searches Microbiome Testing Startup in Billing Probe |language=en-US |work=Wall Street Journal |url=https://www.wsj.com/articles/ubiome-offices-searched-by-fbi-11556301287 |access-date=2019-04-26 |issn=0099-9660}}</ref> involving the US health insurance program [[Medicare (United States)|Medicare]].<ref name=":0">{{Cite web |title=uBiome to Close Doors One Month After Bankruptcy Filing |url=https://www.biospace.com/article/troubled-ubiome-to-close-doors-and-sell-off-assets/ |access-date=2021-03-09 |website=BioSpace |date=October 2, 2019 |language=en-US}}</ref>
In 2021, the [[Securities and Exchange Commission]] charged two of the cofounders (Richman and Apte) with defrauding investors.<ref name=":3">{{Cite web |last=SFGATE |first=Katie Dowd |date=2021-03-21 |title=SF couple who ran trendy poop-testing startup charged with fraud |url=https://www.sfgate.com/news/editorspicks/article/ubiome-richman-apte-sec-filing-charges-fraud-16042042.php |access-date=2021-03-23 |website=SFGATE |language=en-US}}</ref><ref name=":4">{{Cite web |title=SEC.gov {{!}} SEC Charges Co-Founders of San Francisco Biotech Company With $60 Million Fraud |url=https://www.sec.gov/news/press-release/2021-49 |access-date=2021-03-23 |website=www.sec.gov}}</ref> The couple were also charged with [[federal crimes]] including [[Conspiracy (criminal)|conspiracy]] to commit fraud and [[money laundering]].<ref name=":5">{{Cite web |last=Morse |first=Jack |title=Turns out that poop-testing startup was full of it |url=https://mashable.com/article/ubiome-poop-testing-startup-founders-charged-doj-sec/ |access-date=2021-03-23 |website=Mashable |date=March 22, 2021 |language=en}}</ref> Since 2021, the [[FBI]] has considered the founders to be fugitives.<ref name=":6">{{cite web |last=Dockser Marcus |first=Amy |date=2021-11-24 |title=The Biotech Startup That Became an FBI Target |url=https://www.wsj.com/podcasts/the-journal/the-biotech-startup-that-became-an-fbi-target/68b0d752-2275-4860-8153-d0877883353b |access-date=2022-04-03 |work=[[Wall Street Journal]] |medium=podcast}}</ref><ref>{{Cite news |title=Founders of poop-testing uBiome, reportedly on the run, charged by SEC with defrauding investors |url=https://endpts.com/founders-of-poop-testing-ubiome-reportedly-on-the-run-charged-by-sec-with-defrauding-investors/ |access-date=2023-02-04 |website=Endpoints News |language=en}}</ref>
==History==
=== Founding ===
The company was founded by Jessica Richman, Zachary Apte, and Will Ludington who were scientists in the [[California Institute for Quantitative Biosciences]].<ref>{{cite news|last1=Lee|first1=Teresa|title=Swabbing for Science|url=http://berkeleysciencereview.com/article/swabbing-for-science/|work=The Berkeley Science Review|date=April 22, 2013|access-date=October 29, 2016|archive-date=October 29, 2016|archive-url=https://web.archive.org/web/20161029180144/http://berkeleysciencereview.com/article/swabbing-for-science/|url-status=dead}}</ref>  In November 2012, uBiome generated $350,000 through a crowdfunding campaign.<ref>{{cite journal|last1=Vachelard|first1=J|last2=Gambarra-Soares|first2=T|last3=Augustini|first3=G|last4=Riul|first4=P|last5=Maracaja-Coutinho|first5=V|title=A Guide to Scientific Crowdfunding.|journal=PLOS Biology|date=17 February 2016|volume=14|issue=2|pages=e1002373|pmid=26886064|pmc=4757556|doi=10.1371/journal.pbio.1002373|doi-access=free}}</ref>  The founders received mentoring and funding from [[Y Combinator (company)|Y Combinator]] and further funding from [[Andreessen Horowitz]] and 8VC.<ref>{{cite news |url = https://techcrunch.com/2014/08/18/ubiome-raises-4-5m-from-angel-investors-andreessen-horowitz-to-crowdsource-microbiome-research/ |publisher = TechCrunch |last = Chokkattu |first = Julian |title = uBiome Raises $4.5M From Angel Investors, Andreessen Horowitz To Crowdsource Microbiome Research}}</ref><ref>{{cite news|last = Dillet |first= Romain |title = Andreessen Horowitz Raises Massive New $1.5 Billion Fund |publisher = TechCrunch |url = https://techcrunch.com/2014/03/27/andreessen-horowitz-raises-massive-new-1-5-billion-fund/}}</ref><ref>{{cite news| url= https://techcrunch.com/2016/11/01/gut-health-startup-ubiome-raised-22-million-and-is-launching-a-dna-test-for-your-poop/ | publisher = TechCrunch |last = Buhr| first = Sarah |title = Gut health startup uBiome has raised $15.5 million and is launching a DNA test for your poop}}</ref>
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 ===
In April 2019, [[Federal Bureau of Investigation|FBI]] agents raided the uBiome office in an investigation over possible insurance fraud<ref name=":1" /><ref name=":2" /> involving the US health insurance program [[Medicare (United States)|Medicare]].<ref name=":0" /> According to company insiders, the company often repeatedly billed patients without their consent and pressured doctors to approve tests.<ref>{{Cite web |last=Farr |first=Christina |date=2019-05-02 |title=Insiders describe aggressive growth tactics at uBiome, the health start-up raided by the FBI last week |url=https://www.cnbc.com/2019/05/02/ubiome-what-really-happened-at-health-start-up-raided-by-fbi.html |access-date=2021-03-09 |website=CNBC |language=en}}</ref>
Cofounders Apte and Richman were put on administrative leave pending an investigation by the company's board.<ref>{{cite news |last=Farr |first=Christina |date=6 May 2019 |title=Health tech start-up uBiome suspends clinical operations following FBI raid |work=[[CNBC]] |url=https://www.cnbc.com/2019/05/06/ubiome-suspends-clinical-operations-after-fbi-raid.html |access-date=18 June 2019}}</ref>
The company filed for [[Chapter 11, Title 11, United States Code|Chapter 11]] bankruptcy (reorganization of debt) in September 2019, amidst the investigation,<ref>{{cite web |title=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 |url=https://www.businessinsider.com/ubiome-what-we-know-microbiome-startup-fbi-raid-ceos-resigned-2019-7 |access-date=2020-05-10 |publisher=[[Business Insider]]}}</ref> and less than a month later it filed for a [[Chapter 7, Title 11, United States Code|Chapter 7]] bankruptcy ([[liquidation]]) and shut down.<ref name=":0" />
In 2021, the [[Securities and Exchange Commission]] charged two of the cofounders (Richman and Apte) with defrauding investors.<ref name=":3" /><ref name=":4" /> The couple were also charged with [[federal crimes]] including [[Conspiracy (criminal)|conspiracy]] to commit fraud and [[money laundering]].<ref name=":5" /> Richman and Apte married in 2019 and relocated to Germany in June 2020. Since 2021, the [[FBI]] has considered them to be fugitives.<ref name=":6" />
===Products and services===
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.<ref name="FastCo">{{cite news|last=Gertner|first=Jon|date=January 7, 2015|title=What's Lurking In Your Microbiome? Possibly, A Cure For Disease|publisher=Fast Company|url=http://www.fastcompany.com/3039891/gut-check}}</ref><ref>{{cite journal|last1=Almalki|first1=M|last2=Gray|first2=K|last3=Sanchez|first3=FM|date=February 24, 2015|title=The use of self-quantification systems for personal health information: big data management activities and prospects.|journal=Health Information Science and Systems|volume=3|issue=Suppl 1 HISA Big Data in Biomedicine and Healthcare 2013 Con|pages=S1|doi=10.1186/2047-2501-3-S1-S1|pmc=4437547|pmid=26019809|doi-access=free}}</ref> In 2015 uBiome received [[Clinical Laboratory Improvement Amendments]] (CLIA) certification from the State of California.<ref name="genomeweb">{{cite news|date=April 28, 2015|title=uBiome Launches CLIA Lab|publisher=genomeweb|url=https://www.genomeweb.com/business-news/ubiome-launches-clia-lab}}</ref> In 2016, uBiome received accreditation from the [[College of American Pathologists]].<ref name="prweb">{{cite news|last=Taylor|first=Julie|date=October 4, 2016|title=uBiome's Laboratory Receives Accreditation by College of American Pathologists (CAP)|publisher=PRWeb|url=https://www.prweb.com/releases/ubiome_s_laboratory_receives_accreditation_by_college_of_american_pathologists_cap_/prweb13735887.htm}}</ref>
=== Technology ===
{{As of|2015}}, the company first amplified a portion of the bacterial gene that encodes [[16S ribosomal RNA]] using [[Polymerase chain reaction|PCR]], then [[DNA sequencing|sequenced]] the amplified 16S ribosomal RNA gene, in order to categorize the bacteria at the [[genus]] level.<ref>{{cite news|last1=Scoles|first1=Sarah|date=7 October 2015|title=I Sent a Sample of My Poop to uBiome -|work=The Crux @ Discover Magazine|url=http://blogs.discovermagazine.com/crux/2015/10/07/poop-sample-ubiome/#.WBQfS-ErKV4|access-date=October 29, 2016|archive-date=October 29, 2016|archive-url=https://web.archive.org/web/20161029181143/http://blogs.discovermagazine.com/crux/2015/10/07/poop-sample-ubiome/#.WBQfS-ErKV4|url-status=dead}}</ref> 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{{clarify|date=March 2021}} and single{{clarify|date=March 2021}} customers sent to them, and web-based software that allowed individuals to view their microbiome and make certain comparisons.<ref name="Newsweek">{{cite news|last1=Khamsi|first1=Roxanne|date=17 July 2014|title=Can Gut DNA Sequencing Actually Tell You Anything About Your Health?|work=Newsweek|url=http://www.newsweek.com/2014/07/25/can-gut-dna-sequencing-actually-tell-you-anything-about-your-health-259348.html|access-date=21 March 2015}}</ref><ref name="Xconomy2014">{{cite news|last1=Tansey|first1=Bernadette|date=18 August 2014|title=Glowing Plants To Nanodiamonds: Y Combinator's Biotechs Debut|work=Xconomy|url=http://www.xconomy.com/san-francisco/2014/08/18/from-glowing-plants-to-nanodiamonds-y-combinators-biotechs-debut/?single_page=true#}}</ref>  A 2014 report in ''[[Xconomy]]'' said the company outsourced the sequencing.<ref name="Xconomy2014" />  The sequencing was done on the [[Illumina (company)|Illumina]] NextSeq500 sequencer.<ref>{{cite web|title=ubiome 0.5.8 : Python Package Index|url=https://testpypi.python.org/pypi/ubiome|access-date=29 October 2016|website=testpypi.python.org|date=June 17, 2016 }}</ref><ref>{{cite news|last1=Mac|first1=Tracy|date=June 2, 2015|title=Interview with Jessica Richman of uBiome|work=The Power of Poop|url=http://thepowerofpoop.com/interview-with-jessica-richman-of-ubiome/}}</ref>
In October 2015 the company introduced an [[mobile application|app]] on iOS using ResearchKit that allowed customers to view their results on mobile devices.<ref>{{cite news|last1=Taylor|first1=Nick Paul|date=Oct 11, 2015|title=UBiome taps Apple ecosystem to broaden microbiome data-gathering drive|work=FierceBiotech|url=http://www.fiercebiotech.com/digital/ubiome-taps-apple-ecosystem-to-broaden-microbiome-data-gathering-drive}}</ref>
uBiome has been compared with [[Theranos]] and [[23andMe]], each of which was also a biotechnology company influenced by [[Silicon Valley]].<ref name="Wired2015">Zhang, Sarah. [https://www.wired.com/2015/11/ubiome-cdc-collaboration/ “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"</ref><ref>{{cite news|last1=Leonard|first1=Andrew|date=December 22, 2015|title=Silicon Valley Will See You Now|work=Modern Luxury: Silicon Valley|url=http://modernluxury.com/silicon-valley/story/silicon-valley-will-see-you-now|quote="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."}}</ref>
=== Citizen science ===
[[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 [[Genetic testing#Direct-to-consumer genetic testing|direct to consumer genetic testing]] initiatives could be ethically conducted at all, and its lack of [[institutional review board]] (IRB) approval.<ref name="WSJ2014">{{cite news|url=https://www.wsj.com/articles/the-ethics-of-experimenting-on-yourself-1414170041|title=The Ethics of Experimenting on Yourself|date=24 October 2014|work=Wall Street Journal|last1=Marcus|first1=Amy Dockser}}</ref><ref>{{cite news|url=https://blogs.scientificamerican.com/urban-scientist/on-ethics-and-self-policing-in-citizen-science/|title=On Ethics and Self-Policing in (Citizen) Science|date=February 22, 2013|work=Scientific American Blog Network|last1=DNLee}}</ref><ref>{{cite news|url=http://www.chronicle.com/article/Crowdsourced-Research-Delves/141795/|title=Crowdsourced Research Delves, Uncertainly, Into the Human Microbiome|date=23 September 2013|work=The Chronicle of Higher Education|last1=Chorost|first1=Michael}}</ref>  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.<ref name="WSJ2014" /><ref>{{cite news|url=https://www.sciencebasedmedicine.org/meet-your-microbes-ubiome-offers-new-service/|title=Meet Your Microbes: uBiome Offers New Service|date=June 25, 2013|work=Science-Based Medicine|last1=Hall|first1=Harriet}}</ref>
The company obtained an [[institutional review board]] approval in July 2013.<ref name="WSJ2014" /><ref name="SciAmStone">{{cite news|last1=Stone|first1=Judy|title=uBiome: Ethical Lapse or Not?|work=Scientific American|url=http://blogs.scientificamerican.com/molecules-to-medicine/2013/07/25/ubiome-ethical-lapse-or-not/|access-date=9 February 2015}}</ref><ref>{{cite news|last1=Jessica|first1=Richman|last2=Apte|first2=Zachary|date=July 22, 2013|title=Crowdfunding and IRBs: The Case of uBiome|work=Scientific American Blog|url=http://blogs.scientificamerican.com/guest-blog/2013/07/22/crowdfunding-and-irbs-the-case-of-ubiome/}}</ref>
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.<ref name="WSJ2014" /><ref>{{cite news|url=http://www.sfgate.com/technology/article/Biotech-startup-turns-to-crowdfunding-5236754.php|title=Biotech startup turns to crowdfunding|date=February 15, 2014|work=San Francisco Chronicle|last1=Lee|first1=Stephanie M.}}</ref>
As of 2015, uBiome offered a $1 million grant program to researchers and citizen scientists for microbiome sampling and related analysis.<ref>{{Cite web|date=May 13, 2016|title=FACT SHEET: Announcing the National Microbiome Initiative|url=https://obamawhitehouse.archives.gov/sites/whitehouse.gov/files/documents/OSTP%20National%20Microbiome%20Initiative%20Fact%20Sheet.pdf|website=obamawhitehouse.archives.gov|publisher=The White House}}</ref>  One winner of the first round of such grants was the [[Centers for Disease Control and Prevention]].<ref name="Wired2015" />
== Awards and recognition ==
In March 2018, uBiome made [[Fast Company (magazine)|''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.<ref>{{Cite news|url=https://www.fastcompany.com/most-innovative-companies/2018/sectors/data-science|title=The 2018 Top 10 Most Innovative Companies by Sector: Data Science {{!}} Fast Company|work=Fast Company|access-date=2018-03-26|language=en-US}}</ref>
== See also ==
* [[Personal genomics]]
* [[Genealogical DNA test]]
* [[Citizen science]]
== References ==
{{Reflist|2}}
== External links ==
* {{official website|https://web.archive.org/web/20190416153433/http://ubiome.com/}} preserved by [[Internet Archive]]
[[Category:Companies based in San Francisco]]
[[Category:Biotechnology companies established in 2012]]
[[Category:2012 establishments in California]]
[[Category:Biotechnology companies of the United States]]
[[Category:Genomics companies]]
[[Category:Citizen science]]
[[Category:Microbiomes]]
[[Category:Microbiology]]
[[Category:Genetic genealogy]]
[[Category:Companies that filed for Chapter 11 bankruptcy in 2019]]
[[Category:Corporate scandals]]
[[Category:Corporate crime]]
[[Category:Medical scandals in the United States]]