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What if you could diagnose endometriosis with a tampon?

What if you could diagnose endometriosis with a tampon?
Technology
On an unremarkable side street in Oakland, California, a few blocks down from an animal dermatologist and just past an organic grocery store, Ridhi Tariyal and Stephen Gire are trying to change how women monitor their health. When I visited their small office in January, a garland of tampons dip-dyed in rainbow colors was strung above a computer monitor—a tongue-in-cheek reference to their work.

The tampon is a sort of totem for NextGen Jane, a startup that Tariyal and Gire founded in 2014. Their plan is to use blood squeezed from used tampons as a diagnostic tool. In that menstrual blood, they hope to find early markers of endometriosis and, ultimately, a variety of other disorders. The simplicity and ease of this method, should it work, will represent a big improvement over the present-day standard of care.

Surgeons diagnose endometriosis—an abnormal growth of endometrial tissue outside the uterus—by inserting a small camera into the pelvic cavity to look for endometrial cells in places other than the lining of the uterus, the only place they should normally grow. If wayward cells are found, the diseased tissue can often be removed on sight. But the average woman diagnosed with endometriosis has already had the disease for over a decade, which can mean years of excruciating pain.

The physical and emotional impact on women’s lives is enormous. But women often believe such pain is normal, so they don’t seek treatment. Delayed diagnoses by doctors relying on subjective reports of pain are also common. “I was told by my doctors that I had a ‘low threshold for pain’ and that I should just get used to it because there was nothing that could be done,” Padma Lakshmi, a television host who founded the Endometriosis Foundation of America, said at a conference in April 2018.

A majority of endometriosis cases are never diagnosed: the most obvious symptoms can have multiple causes, and the severity of the symptoms does not correlate strongly with the severity of the underlying disorder. By some estimates, endometriosis affects 10% of reproductive-age women—roughly 200 million people.

Nevertheless, NextGen Jane did not set out to diagnose endometriosis. The company’s initial focus was on fertility—because, Tariyal says, that’s what venture capitalists were most interested in funding. NextGen Jane is one of hundreds of so-called femtech startups that are developing technologies intended specifically to improve women’s health. Frost & Sullivan, a market research firm, predicts that femtech will be a $50 billion industry by 2025. “Women’s health care,” according to Frost & Sullivan, “remains largely confined to reproductive matters.” According to Tariyal, this has been a major obstacle. “We wish we could go out there and say we just want to diagnose women’s diseases,” she told me. But investors would ask her: “Where’s the money in that?”

NextGen Jane’s story is a case study in how a woman’s health is typically viewed through the lens of her ability to bear children—and how that ingrained bias slows innovation in medicine.

Bruce Peterson

Tariyal, who has a bachelor’s degree in industrial engineering from Georgia Tech, went to work at Bank of America Securities after graduation, but she hated investment banking. If she was going to grind tirelessly, she reasoned, she wanted to do something more meaningful. So she took a job as a research manager and analyst at Bristol-Myers Squibb, a pharmaceutical company. This taught her that she didn’t like big companies but did love medicine. She went back to school, first getting an MBA from Harvard and then a master’s in biomedical enterprise from MIT, with the goal of starting a company of her own.

As a thesis project at MIT, Tariyal tried to launch Ujala, a company that planned to test the blood of would-be partners in arranged marriages for genetic defects their offspring might inherit. It never took off. Consumer genetic testing was still in its infancy, and the business case for the Indian market, where Tariyal was hoping to sell her product, was hard to make to American venture capitalists.

In 2011 she went to work for Pardis Sabeti, a Harvard professor who needed someone to manage a large genetic study in West Africa. It was in Sabeti’s lab that she met Stephen Gire. The two of them traveled through Sierra Leone together to collect samples from survivors of Lassa fever, a deadly hemorrhagic fever broadly similar to Ebola.

Then, in 2013, Tariyal received a fellowship at Harvard Business School designed to encourage graduates to start new life-sciences companies. She was 33 at the time and an aspiring entrepreneur. She was not ready to have children and asked her doctor if she could wait five more years before she tried. She wanted to do a blood test called an anti-Müllerian hormone (or AMH) test that would approximate the number of viable eggs she had. But her doctor didn’t see the need and wouldn’t order it for her. And she was shocked by what the doctor suggested as an alternative: simply try to get pregnant to find out if she could.

This left Tariyal so alienated and frustrated that she decided her only option was to create her own AMH test that women could perform themselves, at home. She called Gire to ask for his help. She wanted to design assays to pick up proteins that would let her determine whether AMH and other hormones could be detected in menstrual blood, instead of blood drawn from veins, so that you wouldn’t have to see a doctor to get tested. A woman could, in theory, just send in a used tampon for analysis.

During her fellowship, Tariyal performed tests that looked at three types of samples—venous blood, blood from a pinprick to the skin, and menstrual blood—to see where they overlapped. “I literally had to run them to a lab to process right away,” she recalls. She was putting the logistical prowess she’d honed in Sierra Leone to use. As a menstruating woman, Tariyal also had an advantage: not only could she include herself in trials, but she was entitled to look at her own results.

To her disappointment, she found that AMH levels are consistently lower in menstrual blood than they are in venous blood. Her initial idea wouldn’t work. But she believed she’d stumbled onto something even better: clear genomic signals in menstrual blood. Though genomics hadn’t been her goal, it was a field rich with possibility. She found some 800 genes that were expressed differently in menstrual effluence and venous blood. The effluence contains not only blood but also endometrial lining, and some cervical and vaginal cells as well. It is, she says, like “getting a natural biopsy from your body.”

With funding of $100,000 and six months of access to genome sequencing equipment at a startup accelerator run by the genomics company Illumina, she and Gire continued to look at menstrual blood samples. In particular, they hoped they might be able to reliably detect changes in gene expression that Linda Giudice, a doctor at the University of California, San Francisco, had recently discovered in women with endometriosis.

They have yet to succeed. Diagnosing diseases from menstrual blood is difficult. Published data establishing the efficacy of such diagnoses remains sparse, though sequencing technologies and other methods of extracting information from blood samples are fast improving. But NextGen Jane’s access to the Illumina equipment ran out in 2015 (although it now uses equipment shared by a collective of genomics companies).

Gire and Tariyal in their Oakland office.

Christie Hemm Klok

NextGen Jane is part of a cluster of firms trying to develop direct-to-consumer tests for endometriosis and other diseases affecting women.

As with any such boom, the surge of femtech companies leaves plenty to be wary of. The rise and fall of Theranos, which falsely claimed to have developed a revolutionary new method of blood analysis, has made people suspicious of biotech startups claiming to reinvent the blood test. A 2016 study by Columbia University researchers found that the overwhelming majority of menstrual tracking apps were inaccurate. Some defaulted to 28-day cycle lengths, though fewer than 15% of women have cycles precisely that long. Other apps predict a baby’s gender from the date of conception, or peddle other pseudoscientific claims.

The device has yet to be approved by the US Food and Drug Administration, but Tariyal says a clinical trial is designed and ready to go. She says she needs to raise several million more dollars to run a trial on about 800 women that could establish the diagnostic efficacy of menstrual blood. It will take her about two years, she says—if she can raise the money.

In a Washington Post op-ed last year, Tariyal outlined some of the challenges in fund-raising for a women’s health startup. “Some of my mentors recommended I mask the technology itself: Strip the deck of ‘menstrual blood’ and call it a novel female substrate, they suggested. Don’t say you’re a ‘women’s health’ company. It signals a lack of scientific heft,” she wrote. “I understood them to mean: Try to look as little as possible like what you really are—a woman-led company utilizing female biology to advance health care for half the population.”
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