Innovation 4 min read

The Wild West of Vaginal Microbiome Testing

Startups are eager to have women test for bacteria linked to STIs, but scientists aren’t so sure yet.

By Heather Millar featured image Andrew Brookes /Getty Images

I’m sitting with about a dozen other women around a table in a biotech startup office south of Market Street in San Francisco, California. We’re passing around a Pap smear probe — a cervical cancer screening test that looks like a miniature toilet brush in the shape of a Christmas tree. We grimace and commiserate about how generally uncomfortable the test can be.

Holding up a slick new SmartJane package for our comparison, Jessica Richman, the co-founder of uBiome says, “We see this new test as something empowering for women.” Richman starts the SmartJane vaginal microbiome probe on its lap around the table. It looks like a souped-up Q-tip on close inspection. Much less scratchy.

We each take a turn holding the probe. Awkward giggles and jokes ensue. I mean, how often have any of us been in a business meeting to discuss the va-jay-jay? I laughed when I first got the email inviting me to a “women’s empowerment breakfast” to discuss this test and “girl power.”

The uBiome execs at the table have no doubt been to countless such gatherings: uBiome crowdfunded their start with an Indiegogo campaign, and have since raised $22 million in Silicon Valley venture capital. All that takes a lot of meetings.

Their vaginal test now joins uBiome’s first product, SmartGut, that allows people to sequence their own microbiome. It turns out that there is some literature that links the vaginal microbiome to infant gut health, to pre-term birth, the risk of HIV infection, infertility and also to HPV infections. The SmartJane test purports to be able to distinguish between various kinds of HPV — five types that are low-risk and will probably clear on their own, and 14 types of HPV that are high-risk and might lead to cervical cancer — by detecting and genotyping the relative abundance of bacteria that have previously been linked to these types of HPV, including Lactobacillus, Sneathia, and Gardnerella.

But uBiome has its eye on microbiomes all over the human body. They’ve filed 50 patent applications for tests for dozens of other things, everything from nebulous “mouth conditions” to cardiovascular disease, neuorological conditions, skin problems, and C-difficile infections. They’ve launched multiple citizen science efforts to leverage their microbiome database, which contains data from more than 150,000 samples. The company also has the backing of some scientific heavyweights, including Joseph DeRisi, a MacArthur genius grant recipient and professor at the University of California, San Francisco (UCSF), Joel Palefsky, an HPV expert at UCSF.

Still, microbiome testing is definitely the frontier of medicine. Several companies have been trying to unlock the potential of the microbiome for a while, but the information they can give consumers remains limited. For one, researchers have only identified a small, small fraction of the bacteria with whom we share our bodies.

Yet, direct-to-consumer tests like SmartJane could lead to a testing hysteria among folks who’s results turn up interesting vaginal flora. And doctors don’t know what to do with this information clinically. Does it make sense then to test for things for which we don’t necessarily have a clear clinical battle plan?

Secondly, scientists are still not sure exactly how these tiny flora and fauna interact with each other, and with us. Most studies have been done in very small patient groups, and have found correlative relationships, not definitive ones that say the presence — or absence — of a certain type of bacteria causes HPV, or cervical cancer, or other diseases. And it appears that HPV status can vary widely, depending on things like hormonal status.

Many scientists remain skeptical. “I am not sure that any 16S rRNA test of the vaginal microbiome can be used to categorically say anything about the vaginal health of an individual, at least not in a way that would have actionable advice,” says Jack Gilbert, the director of the Microbiome Center at the University of Chicago.

But uBiome’s main selling point seems to be that the test can be done discreetly, so women won’t put off making sure they’re healthy down there. Smart Jane comes in two variations: one that people can order themselves (less detailed) and another, more comprehensive test that must be prescribed by a doctor. It’s also covered by some insurance plans.

It’s likely we will see more and more direct-to-consumer microbiome tests, as science clarifies how the microbiome affects health. And it certainly seems that it’s uBiome’s plan to be the market leader as that unfolds.

Soon, if Jessica Richman’s dreams come to pass, we may all be obsessing about the various bacterial colonies we host. Just don’t expect the skies to part and all to be revealed just yet. A fair bit of science has yet to be done.