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The femtech duo analyzing discharge to detect female-related diseases

Interview

The femtech duo analyzing discharge to detect female-related diseases

Medical professionals often diagnose diseases based on bodily fluids, but vaginal discharge has long been considered taboo. “Most men don’t even know what it is,” say Dr. Shlomit Yehudai-Reshef and Dr. Inbal Zafir-Lavie, of Gina Life, who are developing a home-testing kit to detect a variety of diseases, from endometriosis to cervical cancer

Roni Dori | 15:00  15.11.2021
“Vaginal discharge is an excellent source of clinical and biological information about what is happening inside of our bodies, but so far it hasn’t been researched,” says Dr. Shlomit Yehudai-Reshef, Manager of the Clinical Research Institute at Rambam Medical Center (CRIR). “It’s filled with thousands of biomarkers - different proteins whose levels rise or drop corresponding to various physiological conditions, from cancerous tumor growths in the ovaries or cervix to issues with ovulation, and even endometriosis. Each pathology can be characterized by its unique biomarker-profile.”

 

So why has medical research ignored this area for so long?

“We have a few theories in regard to that,” says Dr. Inbal Zafir-Lavie with a smile, who is the co-founder of the duo’s company, Gina Life. “The politically correct answer is that the volume of discharge is relatively low, it isn’t like blood. Recently, scientists have developed methods that can analyze very small sample volume, whether that be mucus, tears, or spinal fluid.”

From right to left: Dr. Shlomit Yehudai-Reshef and Dr. Inbal Zafir-Lavie. Photo: Elad Gershgoren From right to left: Dr. Shlomit Yehudai-Reshef and Dr. Inbal Zafir-Lavie. Photo: Elad Gershgoren From right to left: Dr. Shlomit Yehudai-Reshef and Dr. Inbal Zafir-Lavie. Photo: Elad Gershgoren

And what is the non-politically-correct answer?

“When I give lectures in front of men about this topic, even in a professional conference setting, I need to explain what discharge is. They simply aren’t aware of it. And if you aren’t aware of a certain biofluid, how can you study it? It’s that simple. Typically, doctors examine discharge by color and scent, or even take a specimen, but it isn’t the same as what we do”.

In a polite, diplomatic manner, Zafir-Lavie relates to what more and more women have been saying loudly and boldly over the past decade: that the world of medicine is controlled and managed by men. In Dr. Elinor Cleghorn’s page-turning book, “Unwell Women: Misdiagnosis and Myth in a Man-Made World,” she notes that many male doctors regard female pain as either mentally-health induced, emotional, or simply dismiss it as hormonal. This is one reason why so few women receive referrals to undergo more rigorous testing for health issues, and why they are more likely to be misdiagnosed. Cleghorn believes that male doctors are more likely to examine other bodily excretions such as feces, urine, bile, mucus, or semen, but vaginal discharge is not rendered with equal importance. It has become sort of taboo.

One notable example of this ignorance of treating female pain is the current medical approach to endometriosis. The disease is characterized by heavy and constant bleeding, pain during intercourse, digestive issues, chronic abdominal pain, chronic fatigue, and difficulty getting pregnant. Today, one out of 10 women at childbearing age suffers from the disease, but typically a decade goes by until doctors are able to provide a proper diagnosis. “Doctors didn’t believe me, they assumed that it was a mental health issue and wanted me to take antidepressants,” says Avivit Zehavi-Binstock (39), a Pilates instructor from Ness Ziona who suffered for years from endometriosis, and is currently part of the nationwide Endometriosis-Israel board. Her symptoms included heavy bleeding, constipation, and paralyzing pelvic pain, and she was forced to undergo a variety of painful tests: colonoscopies, rectal exams, CT and MRI scans, blood tests, vaginal exams, and 3D and 2D ultrasounds. “But they never found anything,” she recalls. By the time she suffered near bowel obstruction, and was forced to use a catheter, medical professionals diagnosed her with endometriosis, and she underwent surgery to remove lesions from her intestines and urethra.

The femtech duo want to change this absurd reality. Gina Life was founded in 2015 along with Prof. Roni Michaeli, and is developing a platform to identify pathologies based on vaginal discharge. It operates using a smart “pad” that provides early diagnosis for a variety of medical indications - from endometriosis to ovarian and cervical cancers. The product is planned to hit shelves around 2025, and be similar to a regular pregnancy or coronavirus (COVID-19) test. It will save women time and pain of undergoing many inefficient and invasive tests.

“Women can use the an innovative sanitary pad to attach it to their underwear, and wear it for between six to seven hours. Afterward, they can simply turn over the pad, where there is a small contraption on the adhesive side that needs to be pulled and captures the liquid contents. The liquid is then tested on nanometer strips, and within minutes yields results. Those results can then be photographed on a smartphone, uploaded to the app, and a final detailed explanation appears on a smartphone within minutes,” said Yehudai-Reshef.

There is great potential inherent in this particular area of femtech, and many inspiring figures are part of the board, including serial entrepreneur and outgoing Chief Scientist of the Ministry of Industry and Trade Dr. Orna Berry, a cervical and ovarian cancer survivor. The company has also recorded two successful fundraising rounds of over a million dollars each. Recently, Gina Life won the prestigious Boston MassChallenge startup accelerator’s competition, beating out over 400 different contestants.

A turning point

Since 2019, the two have been examining vaginal discharge samples of healthy women, and also of those diagnosed with ovarian cancer and most recently, endometriosis. They are trying to identify the disease’s unique biomarkers. “We have established the biggest biobank of Vaginal discharge in the world,” says Yehudai-Reshef (52), Gina Life’s Cheif Scientist. During her studies at the Technion Institute of Technology, she was pursuing a doctorate in plants’ molecular biology,. The idea to study vaginal discharge only hit her while she was in midst of completing her postdoctoral studies at Cornell University on phosphate strains in plants. “While analyzing plants by extracting their organs, it occurred to me that I could do the same with bodily fluids, particularly discharge.” While on maternity leave with her youngest son, Ido, her colleague Michaeli relayed that his mother had recently been diagnosed with metastatic ovarian cancer. She shared her idea with him, about devising an exam that could detect such diseases early on.

The idea to specifically focus on vaginal discharge, she said, stemmed from the idea that any type of secretion can be examined in a lab. However, in order to diagnose ovarian cancer and other pathologies within the female reproductive system, it's most effective to examine actual fluids that surround the necessary organs. But after two years, Yehudai-Reshef decided to halt her project. Pharmaceutical Swiss giant Roche announced that it had devised a method for early detection of ovarian cancer by using a blood serum test. “At the time, it seemed pretentious to compete with them, so I put the business aspect aside but still followed up on our in-lab analysis. When their solution tanked, I realized that there were no other solutions out there, and we decided to proceed. We lost a lot of time dealing with the more bureaucratic aspects.”

Zafir-Lavie (41) last maternity leave had also been a turning point in her career, but in a different way. Her eldest sister suffered from Prader-Willi Syndrome, and she had considered it her life’s goal to study such diseases in depth, particularly cancer. Her sister later passed away at 38 from colon cancer, a mere few weeks after Zafir-Lavie gave birth to her youngest. “This is my traumatic story”, she says. “I don’t think it’ll ever get out of my system”.

Zafir-Lavie moved to Philadelphia and became involved in pharmaceutical development at Aevi Genomic Medicine, a Philadelphian-based biotech company that was later acquired by Cerecor Inc. Upon her return to Israel, she later met Yehudai-Reshef. “It was meant to be,” she says. “In 2020, we began receiving funding from MindUp, a digital health incubator run by the Chief Scientist (and funded by the Impact First fund, Pitango Ventures, Medtronic, IBM, and Rambam Medical Center).”

In January 2020, the pandemic hit and nearly put their plans on hold but in reality, had the opposite effect. “Early diagnostic testing was lacking during the pre-pandemic era, and it also lacked the proper resources and technology. Today, everyone knows what a PCR test is, and recognizes the importance of early detection. This helped us,” she said.

This spurred Gina Life to release another product set to hit pharmacies by 2023, aside from its ovarian cancer tests. The second test is a swab that can analyze vaginal secretions and tell whether or not a patient has endometriosis. After sampling, the swab is dipped in a liquid, the data is then run through a system, and different biomarkers appear as lines on a stick. “We’re also developing a smartphone app that can analyze the strips on the pad using an artificial based app algorithm, which can calculate the intensity of the samples provided, and decipher whether or not a patient has endometriosis,” Zafir-Lavie added.

Gina Life plans on finding the exact biomarker for every single pathology. “During our clinical testing, we’re ‘asking’ the cells, which proteins will be the first ones to appear ahead of a diagnosis. In the case of ovarian cancer, we started out with 85 proteins, and found that 32 show a significantly high indication of whether a woman is healthy or ill. We’re now testing out those 32 proteins across a broader population of women. We are utilizing artificial intelligence to help us locate the top five biomarkers,” Zafir-Lavie said.

The duo plan to rely on using only five biomarkers, since analysis of this many biomarkers can be complex and expensive. “We’re looking for the optimal combination to enable precise detection. Sometimes having too many biomarkers could decrease a test’s accuracy. For example, the presence of the cancer biomarker glycoprotein CA-125 signifies whether a patient is suspected to have endometriosis, but it also appears in response to several other physiological occurrences, whether they be ovarian cancer, inflammation, the flu, or even a patient’s decreased mental health state, so it’s not adequate for using.” Gina Life’s biomarkers, Zafir-Lavie added, could be found in the immune system. “Our initial results seem promising,” she said. 

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Gina Life plans on finding the exact biomarker for every single pathology. “During our clinical testing, we’re ‘asking’ the cells, which proteins will be the first ones to appear ahead of a diagnosis. In the case of ovarian cancer, we started out with 85 proteins, and found that 32 show a significantly high indication of whether a woman is healthy or ill. We’re now testing out those 32 proteins across a broader population of women. We are utilizing artificial intelligence to help us locate the top five biomarkers,” Zafir-Lavie said.

The duo plan to rely on using only five biomarkers, since analysis of this many biomarkers can be complex and expensive. “We’re looking for the optimal combination to enable precise detection. Sometimes having too many biomarkers could decrease a test’s accuracy. For example, the presence of the cancer biomarker glycoprotein CA-125 signifies whether a patient is suspected to have endometriosis, but it also appears in response to several other physiological occurrences, whether they be ovarian cancer, inflammation, the flu, or even a patient’s decreased mental health state, so it’s not adequate for using.” Gina Life’s biomarkers, Zafir-Lavie added, could be found in the immune system. “Our initial results seem promising,” she said.

From right to left: Zafir-Lavie, Berry, and Yehudai-Reshef. Photo: Hen Galili From right to left: Zafir-Lavie, Berry, and Yehudai-Reshef. Photo: Hen Galili From right to left: Zafir-Lavie, Berry, and Yehudai-Reshef. Photo: Hen Galili

Chronic pain and infertility problems

Hagar Melnik (32), from Shavei Tzion, relayed that she has been suffering chronic pain caused by endometriosis since the age of 14, and was later diagnosed and underwent surgery. Her mother was subsequently diagnosed after her, after an absurd 40-year delay. “When women suffer from chronic pain, their complaints are dismissed, or they’re treated as if they have hysteria or sent to mental health institutions. It’s clear that if this happened to one out of 10 men and caused them pain during intercourse, constant bleeding, and infertility issues, then this matter would be resolved much faster."

While awareness is rising, it isn’t enough. Tal Arbel (39), owner of the Norman & Bella shoes and bags brand, was also diagnosed with endometriosis over a decade ago, but had to diagnose herself. “One day, when I was 20 years old during my military service, I woke up nailed to my bed. I couldn’t get up or sit, the pain was so traumatic that I needed to be carried,” she said. For many years, doctors considered her to have a hormonal problem or ovarian cysts, but never quite figured out what was wrong. She received hormonal therapy, underwent surgery to remove lesions, and was hospitalized during her menstrual cycle every two to three months.

Later, after she came across the online Israeli Endometriosis Forum, she realized that nothing was wrong with her, she simply had endometriosis. The doctors reaffirmed her diagnosis only after she underwent surgery in which her fallopian tubes, part of her bladder, and a section of her intestines, were removed. “The first words the doctor said to me were: ‘Tal, I’m sorry for all the suffering that you experienced, all those surgeries and hospitalizations were unnecessary.’ There are no words to describe how shattered I was. If I was diagnosed earlier, it could have saved my fallopian tubes and my ability to conceive naturally. It was a big shock.”

These stories prove how vital the need for simple and reliable endometriotic testing is. An Oxford University study published in 2012 found that the economic burden of endometriosis is the same as that of Type-2 diabetes, and estimated to cost the U.S. economy $50 billion. “When a woman comes to the emergency room, is hospitalized, and later told to go home, since ‘it’s just menstrual cramps,’ but then she returns a few hours later with paralyzing pain that could cause her to lose her fertility," says Zafir-Lavie, “that’s a problem. This doesn’t only just harm women, but is a burden on the entire health care system and on society. We need to diagnose this disease earlier, and treat it properly."

A $22 billion market

Femtech, or technologies that aim to improve women’s health, is on the rise. According to recent figures from Pitchbook, since the beginning of the year, femtech ventures have raised $1.2 billion, a rate that is 50% higher than the previous record set in 2019. According to the research firm Global Market Insights, the market is already estimated to stand at around $22.5 billion, and will triple its market value by 2027. And ventures like Gina Life are making it clearer than ever that current R&D is only the tip of the iceberg.

“Investing in women’s health demands a change in thinking, and women are also involved in promoting and finding solutions to their own health issues. The breakthrough idea behind Gina Life’s discovery is something only a woman could come up with,” said Dr. Orna Berry in an email. On the topic of the growing number of female investors, Zafir-Lavie added: “I think that if you have the money, you’ll want to find solutions to issues that are close to your heart. If women have money, a strong academic standing, and an entrepreneurial capability, then they can make real developments in this sector.”

But you’ve also succeeded in encouraging male investors to invest in your company.

“Yes, we’ve both spoken in front of an investor panel, where we had to speak about vaginal discharge in front of ten men in suits and ties. In the beginning, it may seem uncomfortable, but that all goes out the window once they realize the economic potential inherent in this market. That’s what they care about.” 

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