Shaping the future of ovarian cancer diagnosis with femtech

Israeli femtech start-up GinaLife is developing a platform of biomarker strategies supported by artificial intelligence and data science for the early detection of problems in women's health. CEO and co-founder Inbal Zafir-Lavie tells pharmaphorum more.

Six years ago, research scientist Inbal Zafir-Lavie tragically lost her 38-year-old sister Hava Zafir to colorectal cancer. Due to her young age, doctors had been unable to detect the cancer through screening and by the time of diagnosis, it was too late.

The loss of her sister had a profound effect on Inbal. As a graduate of Israel’s Technion in the field of cancer immunology, she says her grief drove her on a mission to transform cancer diagnostics.

A few years ago, Inbal co-founded the start-up GinaLife, where she currently leads a team developing technologies in the field of women’s health, with its first product focused on early detection of ovarian cancer.

“Ovarian cancer is a huge unmet need and more research in this area is critical as early diagnosis can mean the world of a difference for patient treatment,” says Inbal.

“While removing ovaries can save women’s lives, we need a solution that ensures women can be diagnosed and then live a long, happy, healthy life. Women come to us saying ‘I know I have a chance of diagnosis, but I’m scared, I want to have children one day.’ Frankly, I can’t ignore this and knowing how my sister dealt with late-stage cancer I am given the strength and the reason to wake up highly determined to bring a test to market that will enable women to examine themselves and get treated early.”

The test in development by GinaLife analyses vaginal fluids, using artificial intelligence and data science to search for specific cancer biomarkers. While it is being tested at first in-clinic, the company envisions one day it will available for home or remote use to increase access and availability for women around the world.

Early detection

The technology originated from research into ovarian cancer diagnoses conducted by Inbal’s co-founder Shlomit Yehudai-Reshef at Cornell University.

“When she started looking at publications and analysing the research, she realised the majority of studies performed in the past only focused on blood testing - looking for biomarkers that signal early-stage ovarian cancer,” explains Inbal.

“Now this makes sense for several cancers of organs that have a large blood supply, but ovaries are so small - about the size of half of a fist. They are also white, meaning they don’t have a large blood supply. Therefore, by the time you can detect anything in the blood it is way too late – the disease has spread.”

After further research, she concluded the best place to analyse for biomarkers was vaginal secretions. Preliminary data by the start-up supported the hypothesis. A feasibility study examining the biomarker associated with ovarian cancer [CA125] in women with and without ovarian cancer delivered encouraging results.

“First of all, we saw that in the blood and the secretions, the profile is different. There is a higher concentration of biomarkers in secretions which means we can detect it earlier and secondly it was easier to discriminate healthy patients using secretions compared to blood testing.”

The results led to funding from Israel’s government and generated a larger study assessing 60 women screening for different biomarkers. GinaLife is now assembling a signature panel of biomarkers to characterise ovarian cancer patients. A large cohort study measuring 800 women has taken place to narrow down a panel of biomarkers

“What we are trying to do is characterise how does an ovarian cancer patient look like in terms of her proteins and her secretions, and our results show 89% accuracy,” says Inbal.

‘The next big thing’

Having worked with digital health incubator MindUP, Haifa-based GinaLife is now in the process of analysing results of the study and preparing to raise funds for clinical trials in the US and UK.

In addition to ovarian cancer, the company is running a clinical trial for endometriosis and in two years expects to have the first generation of product for ovarian cancer ready. This could closely be followed by an endometriosis product launch, says Inbal.

“We believe femtech is going to be the next big thing. We saw a revolution years ago in breast cancer treatment with the introduction of early detection tools such as mammograms and MRI. Now technologies such as AI will fuel the next revolution in women’s health. Using AI to analyse results, the more data we get, the smarter the test will be.”