The medical field is accustomed to diagnosing disease through evaluation of bodily fluids, but investigation of vaginal discharges has long remained taboo. “Many male researchers don't even know what they are,” explains Dr. Shlomit Yehudai-Reshef.
Dr. Shlomit Yehudai-Reshef, Deputy Director of the Clinical Research Institute at Rambam Health Care Campus together with Dr. Inbal Zafir-Lavie, who holds a Ph.D. in molecular immunology from the Technion-Israel Institute of Technology, decided to create a revolutionary new product that may facilitate the early detection of many diseases affecting women, from endometriosis to ovarian and other cancers.
“Vaginal discharges contain vast amounts of clinical and biological information about what is going on in our bodies, but until today, they have not been the subject of significant research,” says Yuhudai-Reshef. “These fluids contain thousands of bio-markers (proteins) at levels that rise and fall in response to an array of physiological conditions ranging from cancerous ovarian and cervical tumors, to ovulation problems, and endometriosis. Every pathology has a characteristic biomarker profile,” notes Yehudai-Reshef.
In 2015, Yehudai-Reshef and Zafir-Lavie formed the biotech company Gina Life for the purpose of identifying precise biomarker profiles for each type of pathology, using vaginal fluids. Zafir-Lavie, CEO of the company, reveals that only recently have the tools became available to enable analysis of substances using very small samples. “This is the reason why only now we can examine fluids such as vaginal discharges, saliva, tears, and spinal cord fluid.”
Women suffering from an array of diseases, including endometriosis, a frequently misdiagnosed illness, may soon benefit from these promising developments. Endometriosis is manifested in many different ways, including excessive bleeding during menstruation, painful sexual intercourse, digestive issues, chronic tiredness, and difficulties with pregnancy. Even though 1 in 10 women in their child-bearing years suffer from this condition, the average time for a diagnosis to be made can be a decade or more.
Yehudai-Reshef and Zafir-Lavie set out to change this cruel reality. The Gina Life System uses a “smart pad” attached to a woman's underwear. The vaginal fluids are absorbed through tiny channels onto special adhesive strips. The strips are photographed using a smartphone and uploaded to an application that provides the test results within minutes.
The system is scheduled for release to pharmacies in 2025, and should be available for purchase “off the shelf,” much like home pregnancy test kits or COVID-19 tests. Its use may save women from unnecessary invasive testing, surgeries, and years of searching for a diagnosis.
Rambam's BioBank is playing a vital role in this venture. Since 2019, the BioBank has collected hundreds of vaginal discharge samples from both healthy women and women suffering from a variety of diseases. “To the best of my knowledge, this is the first BioBank of its kind in the world,” says Yehudai-Reshef. “At first, we collected samples from women with ovarian cancer and healthy women. During the last year-and-a-half we have also collected samples from women with endometriosis. Together with Dr. Yuri Paz, Director of the Gynecological Endoscopy Unit, and Dr. Ido Mik, a senior physician in the Division of Gynecology and Obstetrics, we are working on identifying the unique biomarkers of these pathologies.”
Clinical trials have begun. Dr. Yehudai-Reshef states, “We are trying to determine which cell proteins are the first to indicate the presence of disease. For example, in the case of ovarian cancer, we began with 85 proteins and narrowed this down to 23 proteins that demonstrated a high probability of disease. We are now examining these 23 proteins in a larger population of sick versus healthy women. Based on our clinical trials, and using artificial intelligence, we want to determine the five proteins that will serve as biomarkers with the strongest correlation with disease.”
In 2020, Yehudai-Reshef and Zafir-Lavie's proposal for Gina Life was accepted by the prestigious digital health incubator MindUp, a joint venture of Rambam, medical technology manufacturer Medtronic, computer giant IBM, and venture capital firm Pitango, just as the worldwide coronavirus pandemic erupted. But the pandemic actually helped their efforts. “Today, everyone is familiar with PCR tests and swabs, and it is much easier to explain the advantages of early detection of a disease,” the two scientists explain.
Gina Life has already gained international recognition as a promising start-up venture and has raised significant investments, including from female investors interested in “femtech” – technology used to focus on women's health.