Enhanced Fertility test kit and digital platform certification for new market entry

世界卫生组织将不孕不育定义为在无保护措施的性交后6个月(女性35岁)或12个月(女性35岁)后无法怀孕。全世界有1/6的人患有此病。他们平均需要7年才能生下一个孩子：3.2年后得到诊断，1.6年后去看专家，再经过2.2年的生育治疗。增强型生育力已经在通过家庭诊断试剂盒、经过验证的在线评估、带有AI/ML驱动的建议的患者门户以及更快地转诊到专家那里，来解决“3.2年后诊断”和“1.6年后找专家”的问题。英国的患者可以通过增强生育应用程序获得这些服务。在获得英国创新女性创新奖后，增强生育已经开始建立一个数字平台，以解决“2.2年生育治疗”的问题。该医生门户网站将于2022年9月面世，将允许专业临床医生在治疗前为他们的英国患者请求测试，可视化患者的健康数据，远程评估这些患者，并为数据驱动的决策(精准医学)提供见解。目前的提案是一个为期6个月的项目，旨在认证增强生育力测试套件并将门户软件本地化，为进入欧盟提供一个新的地理市场，创造新的收入来源。患者将受益于更快地获得诊断，临床医生将能够远程评估他们的患者，无论是在英国还是欧盟，并使用数据驱动的见解来做出个性化生育护理的决定。

The World Health Organisation defines infertility as the inability to conceive after 6 months (for women < 35) or 12 months (for women \>35) of unprotected intercourse. It affects 1/6 people worldwide.It takes them on average 7 years to have a baby: 3.2 years to get a diagnosis, followed by 1.6 years to access a specialist, and a further 2.2 years of fertility treatment.Enhanced Fertility is already addressing the '3.2 years to diagnosis' and '1.6 years to access a specialist' with at-home diagnostic test kits, a validated online assessment, a Patient Portal with AI/ML-driven recommendations and faster referrals to specialists. Patients in the UK can access these services through the Enhanced Fertility App.After winning the InnovateUK Women in Innovation Award, Enhanced Fertility has started building a digital platform to address the '2.2 years of fertility treatment'. This Doctor's Portal will be available by September 2022 and will allow specialist clinicians to request tests for their UK patients ahead of treatment, visualise patients' health data, assess these patients remotely and receive insights for data-driven decision-making (precision medicine).The present proposal is a 6-month project to certify the Enhanced Fertility test kit and to localise the portal software, affording EU entry as a new geographic market, generating a new revenue stream. Patients will benefit from faster access to diagnostics and clinicians will be able to assess their patients remotely, both in the UK and EU, and use data-driven insights to make decisions that personalise fertility care.