Women’s vaginal cultures may be among the highly sensitive personal information seized as evidence in the latest FBI raid on a health-tech start-up.
Federal agents confirmed that they had gathered computers and evidence from the offices of uBiome, a company that promises to tell you what bacteria are living in your gut or vagina last month.
The San Francisco-based company is being investigated on suspicion of fraudulent insurance billing practices, according to the Wall Street Journal.
uBiome said in an email to clients that it was fully cooperating with the FBI’s investigation, but that means that the data those clients entrusted to the company – including vaginal swabs – could fall into some very unexpected government hands.
Data collected by uBiome are just the latest from a health and wellness startup founded on questionable science to go the way of Theranos and Nurx.
The FBI raided uBiome last month, seizing information and computers to investigate the microbiome-testing start-up for fraud. Among the property that the FBI could have taken were vagina cultures (file)
Launched in 2012, uBiome claims to use machine learning, AI and ‘statistical genetics’ to profile microbiomes.
To do this, have this done a client has to send in a sample, either a of their fecal matter (to do the SmartGut test) or vaginal fluid, obtained via a swab (to do the SmartJane test).
Then, the sample is run through uBiome’s sequencing tech.
Each sample is also analyzed against uBiome’s database of microbiomes to work out what flora it might match.
That database is made up of data from ‘hundreds of thousands of people’ gathered over five years.
And all that data, including the swab sent in by Vice writer Samantha Cole, are now accessible to the FBI.
Since the agency is investigating uBiome for its insurance billing practices, it’s unclear if client data would have any use to the FBI.
But it certainly could wind up out of the hands of uBiome.
In light of the investigation, the company informed its clients that it will halt all testing for the time being, and offered to destroy patient samples upon request, according to Cole.
Even before uBiome – or Theranos before it – was under investigation, doctors say the medical utility of its data analysis was questionable.
The SmartJane test promises to tell women the makeup of their vaginal flora, as well as whether they have any STIs, including HPV – and if they have the latter, what strain.
When asked about her thoughts on the technology that uBiome uses, Dr Harriet Hall, a retired family physician for the US Air Force who now edits Science-Based Medicine said the tech’s legitimacy was ‘irrelevant’ because we don’t really know what it means or how to use it.
With regard to SmartJane, ‘we don’t know what constitutes health [vaginal] flora,’ Dr Hall said.
‘We don’t have any criteria for diagnosing “unhealthy” flora and we don’t have any idea when it would need treating or how to treat.’
So, SmartJane may not have all that much health value to patients and their doctors.
But the data collected by the company certainly might have value to other companies.
In addition to her microbiome data, Cole wrote that the SmartJane test came with an extensive questionnaire about her lifestyle, sex life, menstrual cycle and even the forms of birth control she had used.
She worries that this data could be very valuable demographic information to marketing firms that might acquire the information from uBiome via a data broker.
It’s unclear what will become of data from uBiome – or what has become of the blood samples collected by Theranos before the ill-fated company closed down – but doctors seem fairly certain that, at least for now, that information is not going to do much for patients, even if the FBI hasn’t collected it.