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Gonorrhea. The SmartJane test is not the way to diagnose this.


The uBiome company’s SmartJane test claims to use state-of-the-art DNA sequencing technology, machine learning, artificial intelligence, statistical genetics, algorithms, and other proprietary innovations so women can assess their own vaginal health. Customers collect samples with vaginal swabs and mail them in for processing. They get a report of findings for 55 components of the vaginal microbiome: 14 high risk Human Papillomavirus (HPV) strains that can lead to cancer, 5 low-risk HPV strains associated with genital warts, 4 pathogens that cause sexually transmitted infections (chlamydia, gonorrhea, syphilis, and Mycoplasma genitalium) and 32 bacteria that they consider to be clinically important.

I was only able to locate , published on PLOS One on May 1, 2019. It did not demonstrate any clinical benefits. Normal reference ranges for its test results were determined by testing a group of 50 self-reported healthy women (hardly a reliable validation!) It concluded:

…we here present a vaginal health assay that for the first time combines the detection of the most important bacterial and viral indicators of vaginal health and disease. We envision that this test has the potential to provide clinicians and patients with a more comprehensive understanding of the vaginal microbiome, and to encourage women to take an active role in related conversations with their doctors. We also hope that by improving accessibility through self-sampling, we may encourage more women to engage with current screening and treatment guidelines for vaginal pathogens and cervical cancer.

That’s speculation and wishful thinking, not meaningful scientific evidence.

Critics speak out

says “Research on the vaginal microbiome is still at an early stage and doctors say there’s no use for the data in treating patients right now.” They quote Dr. Jennifer Gunter “I can see no value in knowing the 32 (or however many) types of vaginal bacteria. None at all outside of a research setting; I see that leading to unnecessary worry”. They quote Jeanne Marrazzo, who says “We don’t really have any interventions to change what they are potentially going to find.” The company’s website mentions the possibility of dietary changes, pre-biotics, probiotics, etc. but there is no evidence that any of these interventions are effective in improving patients’ health. Elsewhere, Dr. Jennifer Gunter is quoted as saying, “We have no idea what the data means. We know the vaginal microbiome changes throughout the day as well as day to day, and so this snapshot tells you nothing…To suggest otherwise is disingenuous on the part of the company.”

Misconduct

that the company used aggressive marketing tactics, encouraged repeat testing, and billed patients for multiple tests without the patient’s knowledge or consent. A doctor’s order is required for testing, but they hired doctors and paid them up to $180 per hour to approve requests, encouraging them to quickly approve every request. They “upgraded” samples without permission and billed insurance companies and Medicare two or three times for the same set of tests. They billed for tests that were never done. Following numerous customer complaints, the FBI raided the company’s San Francisco offices in April 2019 and seized computers and files. The company’s CEOs and founders were placed on administrative leave. The uBiome Board is cooperating and plans its own independent investigation of billing practices. After the raid, uBiome halted sales of the SmartJane test. They stress that this is only a temporary suspension.

The uBiome company was founded in 2012 by a computer scientist and a biophysicist. They started with crowdfunding and eventually attracted more than $100 million in venture funding. Last September the company was valued at $300 million. Comparisons with Theranos are inevitable. Both had founders who were not experts in the field, venture capital funding and rapid growth, unethical practices leading to downfall, and a rationale that simply didn’t make sense.

Privacy concerns

Patients who sent vaginal swabs to uBiome are worried. if the collected data might be leaked or sold. She had filled out a questionnaire about her lifestyle, sex life, menstrual cycle and the birth control methods she had used. She had relied on the company to protect her privacy, but now the FBI had the data.

What’s the point?

“NOTE: The test is not intended to replace traditional Pap smears or well-woman visits and does not diagnose or treat any disease.” If it can’t diagnose any disease, why does it test for them? What does a positive SmartJane test for syphilis or gonorrhea mean?

Since an appointment with a doctor is still necessary, why bother with a SmartJane test? A doctor can detect and treat cancer, infections, and sexually transmitted diseases, and can test for other conditions not addressed by SmartJane, such as HIV/AIDS and herpes. Is there any value in knowing that you are infected with a specific strain of human papillomavirus (HPV)? The majority of these infections will resolve over time and will never cause any problems. A minority will lead to cancer, but we have an effective vaccine to prevent those cancers. It makes much more sense to get the vaccine than to test for HPV infection.

Vaginal screening tests not indicated

The fact that we can do a screening test doesn’t mean that we should. The US Preventive Services Task Force (USPSTF) has carefully thought-out guidelines for screening tests, and the tests in SmartJane are not recommended. Screening for something that has a low prevalence in the population typically produces more false positive results than true positives, leading to worry and unnecessary invasive testing. Early detection of an abnormality is useless in the absence of an intervention that can change the outcome. The multiple tests offered by Theranos and uBiome amounted to poorly conceived fishing expeditions that were more likely to mislead than to benefit customers.

The care and feeding of the vagina

Sex sells. Ads for penis enlargement led the way, and vaginal quackery soon followed. I wrote an article about it for Skeptical Inquirer titled ““. Gwyneth Paltrow advocates steaming the vagina and inserting jade eggs. There is douching, Holy Yoni Oil, yogurt- and vodka-soaked tampons, herbal detox pearls, Japanese vagina-tightening sticks, ground-up oaks galls (formed by wasp larvae), anion strips, , orgasm shots, and even vaginal rejuvenation surgery. And then there are the foreign body stories like “.” News flash: the vagina is self-cleaning and requires no special care or feeding. Especially not crickets!

Conclusion: good marketing but not good science

The appeal of SmartJane to customers is obvious. What woman wouldn’t want to “meet her vagina” and know what microorganisms are living there? People love to get detailed personal information, whether it’s true or not; that’s why they read horoscopes and visit fortunetellers. Microbiome research is new and sexy. It has great promise, but it just isn’t ready for prime time yet. The claims of this company can be disregarded unless they can provide evidence from controlled studies showing that using the SmartJane test objectively improves clinical outcomes. Not just a change in some lab test, but actual POEMS (patient-oriented evidence that matters). I’m not holding my breath.

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Posted by Harriet Hall

Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, .