One of the key obstacles in delivering precision medicine to women is access to care.
“You can have cutting edge tech and innovation,” observes Mikyelyan, “but without infrastructure in place to disseminate that tech, it won't reach the patients. That’s a political and sociological issue on a global scale.”
But perhaps the biggest challenge to date has been the lack of focused research and funding.
“That’s slowly changing,” says Mikyelyan. “There’s been more in the digital health space recently than in diagnostics and pharmaceuticals. But we’re starting to see more innovation in diagnostics and pharma with companies like Organon, a global healthcare company with a portfolio of therapies and products in women’s health.”
While big investors can see the potential in innovative digital technology, they want to see more evidence before investing in ‘personalised’ vaginal microbiome treatments. Start-ups such as Freya Biosciences are reticent to call their work precision medicine at this early stage which is understandable.
The vaginal microbiome is constantly changing day to day, throughout the menstrual cycle, and with pregnancy and menopause, because of hormonal fluctuations.
“That makes it hard to design treatments,” says Mikayelyan. “You see that with trial results; there can be a lot of variability and it’s difficult get reproducible results which are what’s required to take to the U.S Food and Drug Administration to get approved.”
Clearer guidelines are needed for microbiome-related biomarkers and with regards to the safety and efficacy of potential treatments. While numerous companies now offer personalised assessment of the vaginal microbiome, more research is needed to interpret these results in a meaningful way. Without a more nuanced understanding of what constitutes a healthy vaginal microbiome for each individual, it will be difficult to make advances in personalised treatments.
“The problem is with more chronic and recurrent vaginal conditions,” says Mikayelyan. “Do differences in individual microbiomes cause that? We need to know in order to create precision treatments. That is a key area that still needs to be solved.”