A new noninvasive approach can harness vast amounts of clinical and biological information.
Testing Female Fluids To Detect Signs Of Early Disease
Diagnosing disease through analysis of bodily fluids, like blood or saliva, is nothing new. Vaginal fluids, too, contain much clinical and biological information, but until now have not been the subject of much research.
“Many male researchers don’t even know what they are,” said Dr. Shlomit Yehudai-Reshef, deputy director of the Clinical Research Institute at Rambam Health Care Campus in Haifa.
“These fluids contain thousands of biomarkers [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.”
Yehudai-Reshef and molecular biologist Inbal Zafir-Lavie formed a biotech company, Gina Life, in 2015 and have been identifying precise biomarkers profiles for each type of pathology using vaginal fluids.
Now, using newly available tools to analyze very small samples, they’re creating a revolutionary product to facilitate the early detection of many diseases affecting women — from endometriosis to ovarian and other cancers.
The Gina Life System uses a “smart pad” attached to a woman’s underwear. Discharges are absorbed through tiny channels onto adhesive strips. The strips are photographed using a smartphone and uploaded to an application that provides test results within minutes.
Scheduled to be sold off the shelf in pharmacies in 2025, pending results of clinical trials, this product could save women from invasive testing, surgeries, and years of searching for a diagnosis.
The system was developed using hundreds of vaginal discharge samples collected since 2019 and stored in Rambam’s BioBank.
“To the best of my knowledge, this is the first BioBank of its kind in the world,” said Yehudai-Reshef.
Rambam Health Care Campus is an academic hospital in northern Israel.
“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 OB/GYN, we are working on identifying the unique biomarkers of these pathologies.”
In 2020, Gina Life was accepted into digital health incubator MindUp — a joint venture of Rambam, Medtronic, 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 women explain.
Produced in association with Israel21C.