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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Medical Laboratory Testing Company uBiome Raided by FBI for Alleged Insurance Fraud and Questionable Business Practices

Following the raid, the company’s co-founders resigned from the board of directors

Microbiome testing company, uBiome, a biotechnology developer that offers at-home direct-to-consumer (DTC) test kits to health-conscious individuals who wish to learn more about the bacteria in their gut, or who want to have their microbiome genetically sequenced, has recently come under investigation by insurance companies and state regulators that are looking into the company’s business practices.

CNBC reported that the Federal Bureau of Investigation (FBI) raided the company’s San Francisco headquarters in April following allegations of insurance fraud and questionable billing practices. The alleged offenses, according to CNBC, included claims that uBiome routinely billed patients for tests multiple times without consent.

Becker’s Hospital Review wrote that, “Billing documents obtained by The Wall Street Journal and described in a June 24 report further illustrate uBiome’s allegedly improper billing and prescribing practices. For example, the documents reportedly show that the startup would bill insurers for a lab test of 12 to 25 gastrointestinal pathogens, despite the fact that its tests only included information for about five pathogens.”

Company Insider Allegations Trigger FBI Raid

In its article, CNBC stated that “company insiders” alleged it was “common practice” for uBiome to bill patients’ insurance companies multiple times for the same test.

“The company also pressured its doctors to approve tests with minimal oversight, according to insiders and internal documents seen by CNBC. The practices were in service of an aggressive growth plan that focused on increasing the number of billable tests served,” CNBC wrote.

FierceBiotech reported that, “According to previous reports, the large insurers Anthem, Aetna, and Regence BlueCross BlueShield have been examining the company’s billing practices for its physician-ordered tests—as has the California Department of Insurance—with probes focusing on possible financial connections between uBiome and the doctors ordering the tests, as well as rumors of double-billing for tests using the same sample.”

Becker’s Hospital Review revealed that when the FBI raided uBiome they seized employee computers. And that, following the raid, uBiome had announced it would temporarily suspend clinical operations and not release reports, process samples, or bill health insurance for their services.

The company also announced layoffs and that it would stop selling SmartJane and SmartGut test kits, Becker’s reported.

uBiome Assumes New Leadership

Following the FBI raid, uBiome placed its co-founders Jessica Richman (CEO) and Zac Apte (CTO) on administrative leave while conducting an internal investigation (both have since resigned from the company’s board of directors). The company’s board of directors then named general counsel, John Rakow, to be interim CEO, FierceBiotech reported.

John Rakow (center) is shown above with uBiome co-founders Jessica Richman (lower left) and Zac Apte (lower right). In a company statement, Rakow stressed that he believed in the company’s products and ability to survive the scandal. His belief may be based on evidence. Researchers have been developing tests based on the human microbiome for everything from weight loss to predicting age to diagnosing cancer. Such tests are becoming increasingly popular. Dark Daily has reported on this trend in multiple e-briefings. (Photo copyrights: LinkedIn/uBiome.)

After serving two months as the interim CEO, Rakow resigned from the position. The interim leadership of uBiome was then handed over to three directors from Goldin Associates, a New York City-based consulting firm, FierceBiotech reported. They include:

Four testing products remain available for in-home testing on the uBiome website:

What Went Wrong?

Richman and Apte founded uBiome in 2012 with the intent of marketing a new test that would prove a link between peoples’ microbiome and their overall health. The two founders initially raised more than $100 million from venture capitalists, and, according to PitchBook, uBiome was last valued at around $600 million, Forbes reported.

Nevertheless, as a company, uBiome’s future is uncertain. Of greater concern to clinical laboratory leaders is whether at-home microbiology self-test kits will become a viable, safe alternative to tests traditionally performed by qualified personnel in controlled laboratory environments.

Dark Daily reported on the controversy surrounding this trend in “At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists,” October 16, 2017.

It’s a trend worth watching.

—JP Schlingman

Related Information:

Insiders Describe Aggressive Growth Tactics at uBiome, the Health Start-up Raided by the FBI Last Week

FBI Investigating uBiome’s Billing Practices

Turmoil Persists at uBiome with New Management Overhaul Amid FBI Probe: Reports

uBiome Appoints John Rakow as Interim Chief Executive Officer

Another Shakeup at uBiome: Interim CEO Quits

Seven Updates on the Ongoing uBiome Investigation

Microbiome Startup uBiome Cofounders on Administrative Leave after Reports of FBI Raid

Microbiome Testing Startup Under Scrutiny for Billing Practices

At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists

At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists

As science learns more about the human genome, new companies are being formed to offer consumers at-home microbiology test kits, a development many microbiologists consider worrisome

Can consumers rely on the accuracy of at-home microbiology tests that promise to give them useful information about their microbiome? That’s just one question being asked by clinical laboratory scientists and microbiologists in response to the proliferation of companies offering such tests.

Advances in gene sequencing technology, new insights into the human microbiome, and more sophisticated software to analyze test data are fueling the growth of companies that want to offer consumers at-home microbiology test kits. And no less an authority than the American Academy of Microbiology (ASM) states in a 2017 report, that knowledge of the microbiome can revolutionize healthcare as “insights acquired from NGS [next-generation sequencing] methods can be exploited to improve our health as individuals and the greater public health.”

The move towards more “precision medicine” in terms of diagnostics and treatments, according to the ASM, is based in part on microbial genomic testing, which when combined with a patient’s medical history, clinical signs, symptoms, and human genomic information, can help  “create treatment pathways that are individualized and tailored for each patient.”

However, critics worry about overreach given current limitations in the analysis and diagnosis of microbiome data produced by testing, particularly in connection to the rising number of consumer self-testing services aimed at the general public.

No Science to Back Up Claims of Accuracy for At-Home Microbiology Tests

A recent article from the MIT Technology Review, notes that these at-home microbiology testing services, while exciting, can only offer limited information—despite claims. Companies such as Thryve, for example, offer visitors to their website a $99 gut health kit, which they recommend using four times per year. The goal is to use the data to target regimens of supplements and “correct” problems the testing identifies.

Another company, uBiome, offers physician-ordered and customer-requested test kits that the company suggests can determine risk factors for disease. However, critics suggest science cannot currently back up those claims. Concerns about the value of such consumer self-testing, the legitimacy of recommendations based on “diagnoses,” and basic health privacy are leading to serious concerns within the scientific community.

Ethics and Realistic Expectations

One additional criticism of consumer self-testing of microbiomes involves privacy. An NPR article on the American Gut Project (AGP), which Dark Daily reported on in previous e-briefings, notes that those tested may be disclosing quite a bit of information about themselves. The article’s author points out basic privacy and value concerns about the AGP. American Gut Project is a crowd-funded “citizen science project,” and part of the larger global Earth Microbiome Project, described as a “massively collaborative effort to characterize microbial life on this planet.” (See Dark Daily, “Get the Poop on Organisms Living in Your Gut with a New Consumer Laboratory Test Offered by American Gut and uBiome,” September 9, 2015.)

One example of an at-home microbiology test marketed to consumers is the SmartGut by uBiome (above). It is “a microbiome screening test that uses precision sequencing technology to identify key microorganisms in your gut, both pathogenic and commensal.” (Photo copyright: uBiome.)

In her blog post on the Center for Microbiome Informatics and Therapeutics’ website, Tami Lieberman, PhD, claims that “microbiome profiling is messy (and I’m not just talking about the sample collection).” Lieberman submitted samples to American Gut and uBiome for her article. Lieberman’s skepticism of the services is based on two things:

1.     There is no “gold standard” for microbiome DNA profiling technology or analysis methods at this time; and,

2.     Human microbiomes are in her words, “a moving target, changing with age and diet.”

Thus, the best these services can provide, Lieberman argues, is a snapshot of gut microbes at one period of time. Additionally, she claims there is a danger in trying to interpret personal microbiome data. And, Lieberman is not alone in her criticism.

Science Must Be ‘On Guard’ Against Hype about the Usefulness of Microbiome Tests

Martin Blaser, MD, PhD, Director of the Human Microbiome Project at New York University, also criticizes at-home self-tests of microbiomes. In a New York Times article, Blaser points out that the enormous amount of data generated by microbiome testing is “basically uninterpretable” at this time. According to Blaser, scientists can chart the presence, absence, and levels of specific microbiomes and note correlations, but there is no way to know if changes to microbiomes in a particular patient signal disease risk, progression, or development.

The study of microbiomes is still in its nascent stages, so despite there being significant information correlating the presence or absence of specific microbes to diseases, Blaser states that scientists are currently unsure of what that correlation implies. They simply know the correlations exist.

Although discoveries related to human microbiomes, such as the link between fecal bacteria and infant intellect, insights into the connections between gut microbiome and colorectal cancer, and the tenuous and debatable connection between obesity and microbiome diversity make for interesting news, science must be—as William Hanage, PhD, Director of Harvard’s Department of Epidemiology writes in an article for Nature—on guard against allowing microbiomics to be “drowned in a tsunami of its own hype.”

The “gold rush” of companies offering consumers an at-home microbiology test requires skepticism, notes Hanage. He further urges researchers, press officers, and journalists to remain objective. Hanage writes, “Press officers must stop exaggerating results, and journalists must stop swallowing them whole.” Hanage warns that scientists should be on guard against the “buzz around the field” distorting scientific priorities and misleading the public at large. So, while studies of the human microbiome do carry vast potential for medical laboratories and pathologists to change healthcare and healthcare diagnostics, a healthy dose of skepticism is still the best medicine.

  —Amanda Warren

Related Information:

Changing Diagnostic Paradigms for Microbiology, May 2017

Gut Check: Scientists are Wary of At-Home Microbiome Tests

Getting Your Microbes Analyzed Raises Big Privacy Issues

American Gut Project Crowdfunds $1 Million to Study the Human Microbiome

Which Bacteria Are In My Poop? It depends Where You Look

Can I Test the Health of My Gut Microbiota?

Study: Fecal Bacteria Linked with Greater Infant Thinking Skills

Microbiology: Microbiome Science Needs a Healthy Dose of Skepticism

Get the Poop on Organisms Living in Your Gut with a New Consumer Laboratory Test Offered by American Gut and uBiome

Clinical Laboratories Might Soon Be ‘Diagnosing’ Obesity and Guiding Therapies That Utilize Engineered Microbes

Mayo Clinic and Whole Biome Announce Collaboration to Research the Role of the Human Microbiome in Women’s Diseases Using Unique Medical Laboratory Tests

Expanding Knowledge about the Human Microbiome Will Lead to New Clinical Pathology Laboratory Tests

Effort to Map Human Microbiome Will Generate Useful New Clinical Lab Tests for Pathologists

Get the Poop on Organisms Living in Your Gut With a New Consumer Laboratory Test Offered by American Gut and uBiome

American Gut is using test results to create a microbiome database for use by researchers to better understand how microbes impact human health

Have you ever wondered what lurks in the dark corridors of your bowels? Now you can find out. Two entrepreneurial organizations—one a not-for-profit and the other a new clinical lab company—are charting new medical laboratory territory with the offer of an inexpensive poop test that reveals the type of microbes residing in your gut.

Where to Get Your Gut Microbes Analyzed

The not-for-profit organization American Gut, or British Gut in the United Kingdom (UK), which launched as crowd-funding projects on FundRazr, involve a private research project called the Human Food Project (HFP), which was initiated to compare the microbiomes of populations around the world. The Human Food Project is seeking a better understanding of modern disease by studying the coevolution of humans and their microbes.

People who pay American Gut’s $99 test fee (£75 for the UK project) receive a test kit to collect a stool sample to mail back for DNA sequencing. The test results will be provided to participants, but also benefit microbiome research. (more…)