An at-home fertility screening solution: entering the UK market

Discovering the full story about your fertility

The Proov urine test helps women find reasons for their infertility, and improve their chances of having a child. US-based co-founder Amy Beckley has a PhD in pharmacology, and after a long journey with infertility and repeated miscarriages, wondered whether her work with hormones could shed any light on why she had struggled to conceive herself.

Amy’s idea was to develop a test for levels of the hormone progesterone, which need to stay high to increase the chances of becoming pregnant. It is a simple self-test that women can take themselves each morning and report to their healthcare provider. Crucially, it is taken for the whole duration of the woman’s implantation window, rather than current tests which only measure progesterone at a fixed point in time.

Amy explains, "For those who know they have struggled with conception, this test can help pinpoint whether reduced progesterone is responsible, which can then be remedied by their healthcare provider rather than resorting to IVF".

Expanding into the UK market

After inventing the test, Amy set up a company with colleague Ellen Schell in 2016, and launched the beta product in the US in 2017. It is approved by the US Food and Drug Administration (FDA), and has been ‘CE’ marked – conformity assessed for use in Europe and the UK – since 2020. Amy is now seeking NICE approval and for the test to be accepted into the recurrent miscarriage care pathway in the UK.

The potential saving for the UK healthcare system, and individuals who pay privately for their own IVF, is huge, but requires changes to the pathway before IVF is considered.

Reaching the right stakeholders

The challenges that Amy has found with getting Proov test accepted in the UK are what brought her to the NHS Innovation Service. "I quickly realised that I needed a better understanding of this healthcare system, which is very different to the US", explains Amy, "to allow me to position the product and its benefits differently for the relevant stakeholders".

Amy has already received a lot of early, positive feedback from different organisations, and support from the NHS Innovation Service to connect with agencies such as NICE, and key individuals at Integrated Care System level and in NHS England.

The issues that Amy has faced in bringing her product to market, both in the US and UK, have included supply chain issues, the Covid pandemic, and obtaining FDA clearance and the new UK Conformity Assessed (UKCA) marking. Clinical studies and development costs money, and so funding is often an issue. Two papers have now been published showing the effectiveness of the test, which along with positive feedback from clinicians, are helping to make the case for its effectiveness.

Putting patients in control

All the developments to the Proov test are driven by users. With more than 120,000 test kits sold, 30,000 people using the app, and a Facebook community of over 10,000 women, there is a constant feedback on improvements, changes, and how people are using the product. Amy employs a full-time member of staff to collate this information, drawing out common themes. There is also a team of customer care staff, ensuring that everyone who emails with a question receives an answer from a human.

A second product has already been approved in the US that tracks all of a woman’s hormones across their cycle. This will be able to diagnose the three leading causes of infertility in women, covering 87% of cases, and give a much clearer picture of the issues. They are working on making it available for use in the UK and Europe, and the Innovation Service will once again be a key connector to help introduce the product into the NHS.

Amy says, "If you have a good product or idea that meets a need, then keep going. If you get a closed door, then change direction and work towards another door that’s open to you; look for other opportunities".