Menopause is not a disease or a disorder its a long-term hormone deficiency which will be experienced by every woman. There is currently no diagnostic menopause test in the UK that can provide objective data and accurately define a menopause status. Existing over-the-counter hormone tests cannot be used to determine menopause state. The challenges are that menopausal transition affects each woman uniquely and without objective data its difficult to get an accurate diagnosis in a timely manner and deciding whether and how to treat the symptoms is not guided by any objectivity and can be complicated and impersonal. Women over the age of 50 are the fastest growing group in the workforce and the average age for the menopause transition is 51\. Its recently been found that the cost of menopause on the UK economy is a staggering £10 billion for organisations (according to the Balance App). Agile Life Sciences are developing a unique menopause test which is not hormone based but utilises state of the art next generation sequencing to measure the vaginal microbiome from a non-invasive urine sample. We have recently completed a comprehensive pilot study correlating the vaginal microbiome with menopause status. This study further reinforced the unmet need for a test to provide clarity and understanding to women of their menopause journey. Further, qualitative feedback from the pilot study has emphasised a significant underserved and motivated target audience who are seeking solutions. This project will focus on delivering a novel non-invasive urine sample collection and transportation medical device suitable for measuring the vaginal microbiome using next generation sequencing (NGS)

Menopause is a long-term hormone deficiency which will be experienced by every woman. The current management strategies focus on illness not wellness and clinicians are limited by lack of objective and accurate testing options. This leaves women with limited options and treatment plans that are not monitored for efficacy. Agile Life Sciences (ALS) has developed a game changing service which can measure and monitor the effects of hormone changes on the vaginal microbiome - the vaginome. This highly innovative service will provide menopause clinicians with robust data to help guide them in providing the best possible care and treatment plans to peri and post menopausal women. Our project focusses on developing a solution which uses state-of-the-art next generation sequencing technology to analyse urine samples to measure and monitor the bacteria in the vaginome. By monitoring the changes in these bacteria we can identify the menopause phase and the risk of UTIs. By partnering with menopause clinicians, key opinion leaders and end users we will develop a service that is tailored to peri and post menopausal women and enables them to take control of their own health and live a life without limitations. Our at home easy sample collection has been designed to be convenient and allows women to manage their menopause journey with the support of cutting-edge technology. The outcome of the project will be a fully serviceable test for menopause clinicians with a pilot launch to collaborative KOLs within 4 months and the full service launch within 9 months.

Menopause is a long-term hormone deficiency which will be experienced by every woman. The current management strategies focus on illness not wellness and clinicians are limited by lack of objective and accurate testing options. This leaves women with limited options and treatment plans that are not monitored for efficacy. Agile Life Sciences (ALS) has developed a game changing service which can measure and monitor the effects of hormone changes on the vaginal microbiome - the vaginome. This highly innovative service will provide menopause clinicians with robust data to help guide them in providing the best possible care and treatment plans to peri and post menopausal women. Our project focusses on developing a solution which uses state-of-the-art next generation sequencing technology to analyse urine samples to measure and monitor the bacteria in the vaginome. By monitoring the changes in these bacteria we can identify the menopause phase and the risk of UTIs. By partnering with menopause clinicians, key opinion leaders and end users we will develop a service that is tailored to peri and post menopausal women and enables them to take control of their own health and live a life without limitations. Our at home easy sample collection has been designed to be convenient and allows women to manage their menopause journey with the support of cutting-edge technology. The outcome of the project will be a fully serviceable test for menopause clinicians with a pilot launch to collaborative KOLs within 4 months and the full service launch within 9 months.