uBiome, Inc. was a

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

company based in

San Francisco San Francisco (; Spanish language, Spanish for "Francis of Assisi, Saint Francis"), officially the City and County of San Francisco, is the commercial, financial, and cultural center of Northern California. The city proper is the List of Ca ...

that developed technology to sequence the

human microbiome The human microbiome is the aggregate of all microbiota that reside on or within human tissues and biofluids along with the corresponding anatomical sites in which they reside, including the skin, mammary glands, seminal fluid, uterus, ovarian ...

. Its main product analyzed gut microbes in patients with long-term intestinal disorders. Founded in 2012, the company shut down in 2019 following an investigation into possible insurance fraud.

History

Founding

The company was founded by Jessica Richman, Zachary Apte, and Will Ludington who were scientists in the

California Institute for Quantitative Biosciences The California Institute for Quantitative Biosciences (QB3) is a nonprofit research and technology commercialization institute affiliated with three University of California campuses in the San Francisco Bay Area: Berkeley, San Francisco, and ...

. In November 2012, uBiome generated $350,000 through a crowdfunding campaign. The founders received mentoring and funding from

Y Combinator Y Combinator (YC) is an American technology startup accelerator launched in March 2005. It has been used to launch more than 3,000 companies, including Airbnb, Coinbase, Cruise, DoorDash, Dropbox, Instacart, Quora, PagerDuty, Reddit, Str ...

and further funding from

Andreessen Horowitz Andreessen Horowitz (also called a16z, legal name AH Capital Management, LLC) is a private American venture capital firm, founded in 2009 by Marc Andreessen and Ben Horowitz. The company is headquartered in Menlo Park, California. Andreessen ...

and 8VC.

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. In 2015 uBiome received

Clinical Laboratory Improvement Amendments The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. CLIA P ...

(CLIA) certification from the State of California. In 2016, uBiome received accreditation from the

College of American Pathologists The College of American Pathologists (CAP) is a member-based physician organization founded in 1946 comprising approximately 18,000 board-certified pathologists. It serves patients, pathologists, and the public by fostering and advocating ...

Technology

, the company first amplified a portion of the bacterial gene that encodes

16S ribosomal RNA 16 S ribosomal RNA (or 16 S rRNA) is the RNA component of the 30S subunit of a prokaryotic ribosome (SSU rRNA). It binds to the Shine-Dalgarno sequence and provides most of the SSU structure. The genes coding for it are referred to as 16S rRNA ...

using PCR, then

sequenced In genetics and biochemistry, sequencing means to determine the primary structure (sometimes incorrectly called the primary sequence) of an unbranched biopolymer. Sequencing results in a symbolic linear depiction known as a sequence which suc ...

the amplified 16S ribosomal RNA gene, in order to categorize the bacteria at the

genus Genus ( plural genera ) is a taxonomic rank used in the biological classification of extant taxon, living and fossil organisms as well as Virus classification#ICTV classification, viruses. In the hierarchy of biological classification, genus com ...

level. The company had proprietary

machine learning Machine learning (ML) is a field of inquiry devoted to understanding and building methods that 'learn', that is, methods that leverage data to improve performance on some set of tasks. It is seen as a part of artificial intelligence. Machine ...

algorithms that analyzed the sequence data and compared it with the company's proprietary database of microbiomes, built from the samples that partners and single customers sent to them, and web-based software that allowed individuals to view their microbiome and make certain comparisons. A 2014 report in ''

Xconomy Xconomy is a Boston, Massachusetts–based media company providing news on business, life sciences, and technology{{cite web , title=Company Overview of Xconomy, Inc. , url=https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=3 ...

'' said the company outsourced the sequencing. The sequencing was done on the Illumina NextSeq500 sequencer. In October 2015 the company introduced an app on iOS using ResearchKit that allowed customers to view their results on mobile devices. uBiome has been compared with

Theranos Theranos Inc. () was an American privately held corporation that was touted as a breakthrough health technology company. Founded in 2003 by then 19-year-old Elizabeth Holmes, Theranos raised more than US$700 million from venture capitalists a ...

and

23andMe 23andMe Holding Co. is a publicly held personal genomics and biotechnology company based in South San Francisco, California. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample t ...

, each of which was also a biotechnology company influenced by

Silicon Valley Silicon Valley is a region in Northern California that serves as a global center for high technology and innovation. Located in the southern part of the San Francisco Bay Area, it corresponds roughly to the geographical areas San Mateo County ...

.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"

Citizen science

Amy Dockser Marcus Amy Dockser Marcus is an American journalist. As a staff reporter for the New York bureau of ''The Wall Street Journal'', Dockser Marcus won the 2005 Pulitzer Prize for Beat Reporting. Early life and education Dockser Marcus was born and raised i ...

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 Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, med ...

about the company's

citizen science Citizen science (CS) (similar to community science, crowd science, crowd-sourced science, civic science, participatory monitoring, or volunteer monitoring) is scientific research conducted with participation from the public (who are sometimes re ...

business model — namely whether it had actually obtained

informed consent Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...

from its customers, and whether direct to consumer genetic testing initiatives could be ethically conducted at all, and its lack of

institutional review board An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...

(IRB) approval. 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. The company obtained an

approval in July 2013. In 2014, people experienced in biotechnology entrepreneurship also raised questions about the ethics of

crowdfunding Crowdfunding is the practice of funding a project or venture by raising money from a large number of people, typically via the internet. Crowdfunding is a form of crowdsourcing and alternative finance. In 2015, over was raised worldwide by crow ...

a biotech company, as the risks of such ventures are high even for people with scientific and business sophistication. As of 2015, uBiome offered a $1 million grant program to researchers and citizen scientists for microbiome sampling and related analysis. One winner of the first round of such grants was the

Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...

Insurance fraud investigation and liquidation

In April 2019,

FBI The Federal Bureau of Investigation (FBI) is the domestic Intelligence agency, intelligence and Security agency, security service of the United States and its principal Federal law enforcement in the United States, federal law enforcement age ...

agents raided the uBiome office in an investigation over possible insurance fraud involving the US health insurance program Medicare. According to company insiders, the company often repeatedly billed patients without their consent and pressured doctors to approve tests. Cofounders Apte and Richman were put on administrative leave pending an investigation by the company's board. The company filed for

Chapter 11 Chapter 11 of the United States Bankruptcy Code (Title 11 of the United States Code) permits reorganization under the bankruptcy laws of the United States. Such reorganization, known as Chapter 11 bankruptcy, is available to every business, wheth ...

bankruptcy (reorganization of debt) in September 2019, amidst the investigation, and less than a month later it filed for a Chapter 7 bankruptcy (

liquidation Liquidation is the process in accounting by which a company is brought to an end in Canada, United Kingdom, United States, Ireland, Australia, New Zealand, Italy, and many other countries. The assets and property of the company are redistrib ...

) and shut down. In 2021, the

Securities and Exchange Commission The U.S. Securities and Exchange Commission (SEC) is an independent agency of the United States federal government, created in the aftermath of the Wall Street Crash of 1929. The primary purpose of the SEC is to enforce the law against market ...

charged two of the cofounders (Richman and Apte) with defrauding investors. The couple were also charged with federal crimes including

conspiracy A conspiracy, also known as a plot, is a secret plan or agreement between persons (called conspirers or conspirators) for an unlawful or harmful purpose, such as murder or treason, especially with political motivation, while keeping their agree ...

to commit fraud and

money laundering Money laundering is the process of concealing the origin of money, obtained from illicit activities such as drug trafficking, corruption, embezzlement or gambling, by converting it into a legitimate source. It is a crime in many jurisdictions ...

. Richman and Apte married in 2019 and relocated to Germany in June 2020. Since 2021, the

has considered them to be fugitives.

Awards and recognition

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.

References

External links

* {{official website, https://web.archive.org/web/20190416153433/http://ubiome.com/ preserved by

Internet Archive The Internet Archive is an American digital library with the stated mission of "universal access to all knowledge". It provides free public access to collections of digitized materials, including websites, software applications/games, music, ...

Companies based in San Francisco Biotechnology companies established in 2012 2012 establishments in California Biotechnology companies of the United States Genomics companies Citizen science Microbiomes Microbiology Genetic genealogy Companies that filed for Chapter 11 bankruptcy in 2019 Medical scandals in the United States