Human Practices
SWOT Analysis
Strengths:
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Opportunities:
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Values of our Project
When designing our project, we focused our efforts on making a test that would have a strong social and scientific impact. It was important to us to create a tool that both empowered females and helped healthcare professionals diagnose these diseases. We are using a cell-free system, meaning our test is safe, has very few possible complications and is a process relatively familiar to the general public. Unlike the current invasive procedures, our tool consists of a simple blood test, so it is much more accessible and should be much less costly for the NHS. Due to the familiarity of a simple blood test, which many people will have had before, the test will have less anxiety associated with it compared to other diagnostic procedures such as a laparoscopy. Patients will still have to undergo the regular procedure after testing positive, but we believe that our test will greatly increase the number of people who are willing to get tested initially, as instead of going through a surgical procedure they can take a straightforward and easy lateral flow test. As well as this, our diagnostic tool should decrease wait times for diagnosis, as GPs can ask patients to take the test immediately after identifying their symptoms. In addition, we have made an effort to educate the public through iGEM sessions at school and a social media outreach programme. We did this to make sure that our project didn't just focus on diagnosis, but also worked to increase awareness about females' health issues and how to spot symptoms early, so that females don't need to be in the late stages of their condition to notice it.Responsible and User-minded Design
Currently, the diagnostic processes for endometriosis, PCOS and breast and cervical cancers are mostly invasive and uncomfortable for patients. As there are no other options for diagnosis, when a GP suspects a patient has one of these conditions, they undergo a long process to rule out any other option, and then a surgical procedure to diagnose definitively. Our tool would help reduce the time between a patient presenting their symptoms and diagnosis, as it is accessible and easy-to-use, meaning it can be taken as soon as the diseases are suspected. As well as this, females might be more likely to get tested regularly because the test is much faster and only requires a simple blood test. As part of our project, we would recommend introducing a screening programme similar to those already in place for cervical and breast cancers, as they have been influential in saving lives by catching diseases early. We would also endeavour to make this test a part of the yearly health checks that females undergo after turning 40 (if we were to build a company from this product). With our test, we would help more people get diagnosed in the earliest stages, greatly reducing the damage the condition can inflict across the conditions. As well as this, our test would reduce the burden on GPs and the NHS to screen for and diagnose these conditions, as our tool is more cost-effective and convenient than the full diagnostic tests, so GPs can be more certain in their decision to send patients for surgical procedures. At the moment, our diagnostic tool is being tested with the four conditions listed above, but the aim of our project is for it to be used for a multitude of diseases that could fit the test. Since the test is modular, the toehold switch mechanisms can be modified to be able to identify most blood biomarkers for any disease. This means the benefit our test gives to the world would be expanded to a larger demographic, not just those who experience gynaecological diseases.Project Impact
We hope that our project can drastically decrease the time between symptoms arising, and a diagnosis of diseases such as endometriosis, PCOS, ovarian cancer, and breast cancer, at a fraction of the cost of current diagnostic methods. At present, many patients struggle to get a diagnosis for these conditions, having to struggle to convince medical professionals that the symptoms that they face are real. By producing a more efficient tool for diagnosis, we hope that the unnecessary suffering that patients go through whilst waiting for a diagnosis would be minimised. We also hope that by increasing education in these diseases, as if more people are aware of symptoms of diseases, understanding of these conditions will increase. As a result, we have led sessions for pupils in CLS, CLSG, and a session with the year 6 cohort of City Junior School, with the hope of further educating young people on these diseases, to help them in the future. Our sessions also had the aim of teaching pupils about Genetic Engineering, hopefully inspiring them to do further research into the field, and be members of the City of London UK teams in the future. We envision that our tool would be used by phlebotomy departments in Integrated Care Systems in the NHS, to test blood samples of patients in the early stages of a referral to a secondary healthcare, or patients who have been referred to the department to form the basis of a preliminary diagnosis of PCOS, Endometriosis, Cervical Cancer & Breast Cancer. This would be done through the use of a blood test (which can be done in GP Surgeries, before being sent to the lab, or in the department itself), a sample can be taken and miRNA can be detected using our tool. As a result, a preliminary diagnosis for endometriosis, PCOS, ovarian cancer, and breast cancer can be given, to more quickly provide grounds for referrals to more specialised tests to confirm the diagnosis. We believe that by using our tool, a diagnosis of these diseases can occur more rapidly, easily, and cost-effectively, ultimately decreasing the level of suffering of patients awaiting a diagnosis.Fundraising
We began by forming a fundraising strategy roughly outlining the steps we would take: write an investment brief, create a fundraising pitch deck. Then email the brief to every biotech investment firm under the sun, livery companies, biotech design companies, charities, past investors of the COL iGEM projects and anyone we thought might be interested, and then pitch to any companies that wanted an in-person pitch. When writing our investment brief, we kept it accessible to those who had experience in biotech investment and those who didn’t. We included the intricate details of our project and how it worked but also ensured that anyone who skimmed through this very biology-heavy section would still fully understand the project and its aims. First and foremost, one will usually write how the investment will benefit them and their team; however, we emphasised how these investing individuals and companies would profit from the exposure that our iGEM team would bring them. In the iGEM jamboree, in front of many teams and companies, their logo (either in pitch decks, on our team hoodies etc.) would be displayed - demonstrating their philanthropy and kindness. In the end, we didn’t have to give in person pitches to any of our investors - but our biggest win was emphasising how a contribution would benefit us, and also how it would benefit them!Data Collection
“What are the most pressing issues in women's healthcare today?”. This is one of the big questions that the City of London iGEM team was tasked with answering when developing Project Genoswitch. To find out more, we surveyed the wider community, asking a range of questions which provided us with an insight into the importance of education of female healthcare.
Interestingly, respondents ranked their awareness of women's health concerns at 5.51 out of 10 on average. There was a range of 4 across age groups, as seen in Figure 1. However, those between 50 and 60 had the highest average of 8 out of 10, and those aged between 19 and 25 had the lowest average of 4. When comparing responses between men and women, there was an average difference of 0.71, which was much lower than expected. On average, women rated their awareness of women's health concerns at 5.83/10, whereas men ranked their awareness of women's health concerns at 5.12/10. This highlighted the general limited access to female health education, and the impact this has on both men and women. As many of the participants were of school age, we expected a significant number of people to be receiving health information from their schools.
However, as seen in Figure 2, only 41.9% of respondents got any kind of information from their schools, with many saying that the information they received was “surface level”, “minimal", “focused on biology GCSE”, and not discussed outside of science lessons. The internet was shown to be the second most popular place to find information, with 65.3% of surveyors getting information from family and friends. Some participants identified that it was due to the lack of direction towards trustworthy information online, as many used social media but were unsure about the reliability of the content they saw. By asking family and friends about the issues surrounding female healthcare, participants were able to understand the impact it has on people they are close to, but many mentioned they did not understand the bodily processes that occur when someone has a period, or what it means to have PCOS. This lack of knowledge was reflected in the general inability to name symptoms of common health problems in women, specifically endometriosis, PCOS, ovarian cancer, and breast cancer.
As shown in Figure 3, the group who consistently had the largest proportion of people unable to name any symptoms of these diseases were men. Overall, it can be seen that participants struggled the most to name symptoms of ovarian cancer, with PCOS at a close second.
To gain an understanding of what knowledge participants had of these diseases, they were asked to name common symptoms of PCOS, endometriosis, ovarian cancer, and breast cancer. The symptoms most frequently identified were 'lump', 'pain', and 'heavy periods', as shown in Figure 4. Another shocking statistic was men only being able to name 7/10 common symptoms between the 4 diseases mentioned. This once again showed us the importance of educating people on these conditions, which have the propensity to impact 50% of the population. To play our part in educating the community, we created short profiles summarising the main symptoms, diagnostic methods and barriers to diagnosis of PCOS, endometriosis, ovarian cancer, and breast cancer. Many of the respondents of the survey expressed a desire to know more about these diseases. By creating these profiles, we are able to share brief and useful information about an area of healthcare which many people are unaware of.
Disease Profiles
Average time until formal diagnosis after onset of symptoms: 7-9 years.
Barriers to Diagnosis:
Social:- Normalisation of pain in females, symptoms disregarded as more severe menstrual symptoms - which aren't usually addressed.
- Stigma surrounding periods and menstruation.
- Lack of non-invasive means to diagnose the condition.
- May not be painful, and so might not be flagged to doctors.
- Many different clinical presentations.
- Uncertainty surrounding normal and abnormal pain in the female genitalia.
Groups predominantly affected:
- 30-40 year old females.
- Those who have not had children.
- Those whose menstrual cycle usually lasts more than 7 days.
Usual symptoms:
- Pain in your lower tummy or back - pelvic pain – usually worse during your period.
- Period paid that stops you doing your normal activities.
- Pain during or after sex.
- Pain when peeing or pooping during your period.
- Feeling sick, constipation, diarrhoea, or blood in your urine or faeces during your period.
- Difficulty getting pregnant.
- Very heavy bleeding.
- Depression / low mood.
- Pain in other areas of the body (bleeding and damage to organs).
- Increased likelihood of infections.
Current Diagnostic Method:
There is only one definitive method: a laparoscopy. This is a surgery where a small cut is made below the navel and a camera is inserted in the pelvis to check for pelvic abnormalities. It is a highly invasive procedure that can cause infection, bleeding and organ damage.External Outreach
As part of our education aims, we talked to a global children's online education company called Macademia. Macademia aims to provide educational play through games, challenges and engaging content for children from the ages of 2-18 years old through their two brands: Azoomee (for kids up to 6 years old) and DaVinci (for grown ups and kids 7+). While their content does not touch on women’s health, their expertise in children’s education can help us determine how best to capture the interest of audiences of many ages. We spoke to the founders of the company, Estelle and Douglas Lloyd, to gain insight on what content is engaged with most by young audiences so that we could incorporate these ideas into educational plans. Our conversations showed us that children tend to be more receptive to games than the bombarding of information that school health education usually entails. Having interactive games, videos and experiences means the information learnt will be remembered for much longer periods of time, and is more likely to be absorbed. When producing educational materials for schools to use, we would keep in mind what is most likely to be engaging for children as learning about women’s health requires a lot of information to be retained. We would also aim to make these resources a series of short sessions that are presented to students over a long period of time - as our research showed that many repeated sessions will cause the information to be stored in long-term memory, while one long session may also lead to wavering interest over the length of the session and information will not be remembered.
Education
One of our main aims for the project was education. The problem we have encountered many times during our research is the lack of knowledge around PCOS, endometriosis, breast and ovarian cancer. When we carried out a survey we collected data that corroborated our theories - that very few people (especially men) are capable of naming the main symptoms of these four diseases. One of the great benefits of our test is the speed at which it provides results in comparison to modern day diagnostic methods; however, if no one can identify the symptoms to begin with, they will not be aware that they should test themselves. This is when we decided to make education one of the goals of our project. We initially established social media presence on Instagram, Twitter and Facebook - ensuring we tended to the trending platforms for all age groups. On these platforms, we shared posts about our project and will continue to share easily digestible information about the diseases our project is focused on. Our engagement in the two schools began with an article in The Citizen, the CLS (City of London School (for boys)) weekly newspaper to start conversations about our project and the diseases we were researching, accompanied by articles in the weekly newsletters at CLSG (City of London School for Girls). We then followed up with an assembly at CLSG talking about our project, the diseases and overall about synthetic biology. We also spoke to Macademia, an international kids EdTech company that focuses on online education for children between the ages of 2-18 years old and adults to gain more of an understanding on what is the most engaging for this age group. They gave us advice on how to make information digestible especially when tackling topics that require a lot of information to be communicated in a short space of time. Overall, we sought the expertise of experienced individuals in the field of education for children to produce interactive assemblies and online resources - reaching the school community through newsletters, magazines and newspapers. Also using our school communities to collect information through a survey that helped further inform our project and increase our understanding.
UK NSC Criteria for Screening Programmes
We have assessed our project against the UK National Screening Committee's criteria for appraising the viability, effectiveness and appropriateness of a population screening programme. Each criteria has been marked as: Green for fulfilled, yellow for partially met / unable to complete, red for unfulfilled.Some criteria can not be fulfilled as of yet as we have not put our test through clinical trials.
| UK NSC Criteria | Our Diagnostic Tool |
|---|---|
| The condition being screened should be an important health problem as judged by its frequency and/or severity. | Endometriosis 10% of women worldwide have endometriosis (176 million).[1] Symptoms include heavy periods and debilitating chronic pelvic pain (which is exasperated during periods and physical activity), and the condition / treatment can cause infertility.[2] PCOSPolycystic Ovary Syndrome affects roughly 10% of women worldwide. It can increase the risk of developing type 2 diabetes and high cholesterol later in life, as well as cause infertility and irregular/no periods / severe menstrual pain.[3] Ovarian CancerThere are approximately 7,500 new ovarian cancer cases in the UK each year, with a 35% survival rate over a ten year period.[11] In the US, there were an estimated 236,511 women in the United States alone living with ovarian cancer.[10] Symptoms include difficulty eating and persistent abdominal / pelvic pain.[5] Breast CancerAs the most common cancer worldwide[6], breast cancer affects both men and women, however it has a much higher incidence in women. In 2020, 2.3 million women were diagnosed with breast cancer and an estimated 685,000 of these cases resulted in death.[7] In combination these conditions pose a serious health threat for a wide demographic. Most can cause severe symptoms and some have high mortality rates as well as the possibility to give rise to other life-threatening conditions. |
| The epidemiology, incidence, prevalence and natural history of the condition should be understood, including development from latent to declared disease. There should be robust evidence about the association between the risk or disease marker and serious or treatable disease. | The natural history and cause of some of the diseases is known but there is ongoing research into all conditions, especially breast cancer due to its high frequency. Incidence of conditions such as endometriosis is often an approximation, due to the long diagnosis times[2] and similarity of symptoms between multiple diseases (e.g. endometriosis, characterised by painful periods and heavy menstruation can be mistaken for PCOS, multiple cancers, hormonal imbalances, etc.) meaning the conditions often go undiagnosed or misdiagnosed. Our biology team has investigated which biomarkers would be most effective to test for our chosen conditions. The data they have collected shows a strong association between the disease markers and the diseases. |
| All the cost-effective primary prevention interventions should have been implemented as far as practicable. There are no other cost-effective interventions (such as improving treatment or providing other services) that could be introduced within the resources available. | WHO has multiple strategies to reduce global breast cancer mortality, which include three main pillars: health promotion for early detection, timely diagnosis, and comprehensive breast cancer management.[7] The organisation has a plan to reduce breast cancer mortality by 2.5% per year, thereby averting 2.5 million breast cancer deaths globally between 2020 and 2040. The NHS has ensured that affiliated practices always have easily accessible information on early symptoms of breast cancer in the form of leaflets. The NHS has a screening programme in place for breast cancer. Women from the ages of 50-71 will be called in for a mammogram every 3 years. Breast cancer is usually caused by a combination of a family history with the cancer and getting older. This means vaccination programmes and campaigns (for example against smoking for lung cancers) are not applicable. There are no screening programmes currently for ovarian cancer, PCOS or endometriosis as there is no test that reliably / easily and effectively diagnoses these conditions in the early stages.[4][12] Blood tests in most cases are not enough to diagnose the disease and symptoms can represent a multitude of different diseases. Endometriosis is diagnosed through the invasive laparoscopy surgery, ovarian cancer through a blood test and further ultrasounds, CT scans and laparoscopies, and PCOS through an ultrasound scan. These diagnostic methods are difficult to provide to all women and are only used when the disease is suspected. For these conditions better understanding of the disease from doctors and more readily information about them in GP offices would be the best method of cost-effective primary intervention. In our human practices team we are working towards bettering education on these diseases and their symptoms through social media. |
| There should be a simple, safe, precise and validated screening test. | As we are using a cell free system, our test is safe. Our test would comprise a blood test, followed by miRNA purification and fluorescence measurements which are all relatively simple. However, for our test to be shown to be precise and validated, further characterisation is required with the miRNA biomarkers and validation with a large data set of patients. |
| The test, from sample collection to delivery of results, should be acceptable to the target population. | From a patient’s perspective, our sensor would just be a blood test. As such there should not be any issues with it. We are using a cell free system which is sterile and abiotic - there are no bacteria involved which could potentially give rise to objections. |
| The benefit gained from screening outweighs any harms, such as false positives, uncertain findings and overdiagnosis. | NHS screening programmes for gynaecological diseases are influential in minimising their mortality rate. For example, the NHS states that the screening programme for cervical cancer (a related condition) ‘helps save around 5,000 lives each year’.[14] For breast cancer, screening reduces the number of deaths by about 1,300 a year in the UK.[9] Widespread screening programmes using our test would likely have a similar, if not greater effect. With a test that is less invasive people would be more open to attending their screenings and so the NHS would be able to prevent / treat many more cases than before, and so the test would be a huge benefit to both the NHS and the population. Our test would not be offered as a conclusive diagnosis, it would only act as an efficient and cost-effective tool to show if a patient should be referred for further testing. As our diagnostic tool removes the need for years of GP visits, various medications and stress (from the lack of diagnosis), it allows for a much less labour-intensive diagnostic process for the patient and will take strain off of the NHS. Overdiagnosis and false positives could pose an issue for the test, but our tool combined with other established testing methods should provide an incredibly accurate diagnosis. |
| There should be an agreed policy on further diagnostic investigation of individuals with positive test results, as well as which individuals should be offered interventions, and which interventions are appropriate to be offered. There should be evidence that intervention at a pre-symptomatic phase leads to better outcomes compared to usual care. Evidence relating to wider benefits of screening should be taken into account. | After testing positive using our tool, you would be referred back to the NHS to undergo the full diagnostic procedure for the disease (e.g. a laparoscopy for endometriosis). This would be to ensure and validate the diagnosis, as our test is not conclusive. There is ‘robust evidence’ to suggest that cancer survival rates are higher at early stages of diagnosis, especially with breast and ovarian cancers.[15] For conditions such as PCOS or endometriosis, earlier diagnosis could help patients deal with pain and discomfort, or receive treatments earlier on. |
| The testing, diagnosis and treatment, administration, training and quality assurance of the screening programme should be economically balanced with the expenditure on medical care as a whole. | N/A - We do not have the data to support a cost-effectiveness model / to show the possible expenditure as our diagnostic tool has not been run through clinical trials. |
Potential participants should be provided with evidence-based information explaining the purpose and potential consequences of screening and preventative intervention or treatment. Public pressure for widening the eligibility criteria and for increasing the sensitivity of the testing process should be anticipated. Decisions about these parameters should be scientifically justifiable to the public. | When the individual is being screened, information, similar to that on our wiki, could be presented to them. Evidence for the efficacy of screening could only be given once clinical trials have been carried out. The screening interval could also be optimised from these trials. |
There should be a plan for managing and monitoring the screening programme and an agreed set of quality assurance standards. Adequate staffing and facilities for testing, diagnosis, treatment and programme management should be available prior to the commencement of the screening programme. Clinical management of the condition and patient outcomes should be optimised in all health care providers prior to participation in a screening programme. | Clinical management of PCOS, endometriosis and ovarian and breast cancers are optimised by NICE. NICE would be in charge of creating management and monitoring plans for our test, were it to be used clinically. Our test would allow healthcare staff, facilities and ward space to be freed up for other patients.[13] Early detection would reduce the number of cancers diagnosed at later stages where the only option is palliative care, which is more expensive than earlier stage treatment. Easier and more accessible detection of diseases like endometriosis and PCOS would reduce the number of GP visits, for example in the case of endometriosis where 51% of pre-diagnosis endometriosis patients will see their GP 10 or more times with symptoms.[8]An effective test would allow patients to receive their diagnoses quickly and so not need to continually see healthcare professionals for their symptoms, which would free up healthcare facilities and allow patients to receive intervention faster. |
There should be evidence that the complete screening programme (test, diagnostic procedures, treatment/ intervention) is clinically, socially and ethically acceptable to health professionals and the public. There should be evidence from high quality randomised controlled trials that the screening programme is effective in reducing mortality or morbidity, as well as measuring risk for tests that provide information on making an ‘informed choice’. The individual being screened must readily understand this information. The distribution of test values in the target population should be known and a suitable cut-off level defined and agreed. | N/A as this data is only obtainable after testing. Our diagnostic tools would have to undergo large-scale clinical trials to ensure the screening programme would be effective in reducing mortality or morbidity. This data would allow the public to make an informed choice about the diagnostic tool, which would also ensure it is socially and ethically acceptable to health professionals and the public. |
References
1. ^ Meuleman, C., Vandenabeele, B., Fieuws, S., Spiessens, C., Timmerman, D. and D’Hooghe, T., "High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners", Fertility and Sterility., 92(1), pp.68-74, July 2009, Available: https://www.fertstert.org/article/S0015-0282(08)00975-8/fulltext
2. ^ NHS England, "Endometriosis - Overview", N/A, N/A, September 2022, Available: https://www.nhs.uk/conditions/endometriosis/
3. ^ NHS England, "Polycystic Ovary Syndrome - Overview", N/A, N/A, October 2022, Available: https://www.nhs.uk/conditions/polycystic-ovary-syndrome-pcos/
4. ^ Cancer Research UK, "Screening for ovarian cancer", N/A, N/A, N/A, Available: https://www.cancerresearchuk.org/about-cancer/ovarian-cancer/getting-diagnosed/screening
5. ^ NHSinform, "Ovarian cancer symptoms and treatments", , February 2023, Available: https://www.nhsinform.scot/illnesses-and-conditions/cancer/cancer-types-in-adults/ovarian-cancer
6. ^ Sung, H., Ferlay, J., Siegel, R.L., Laversanne, M., Soerjomataram, I., Jemal, A. and Bray, F., "Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries", CA: Cancer Journal for Clinicians, 71(3), pp.209-249, 2021, Available: https://doi.org/10.3322/caac.21660
7. ^ World Health Organisation, "Breast Cancer", N/A, N/A, July 2023, Available: https://www.who.int/news-room/fact-sheets/detail/breast-cancer
8. ^ All Party Parliamentary Group, "Endometriosis in the UK: time for change", N/A, N/A, 2020, Available: https://www.endometriosis-uk.org/sites/default/files/files/Endometriosis%20APPG%20Report%20Oct%202020.pdf
9. ^ Cancer Research UK, "Breast Cancer Screening", N/A, N/A, May 2023, Available: https://www.cancerresearchuk.org/about-cancer/breast-cancer/getting-diagnosed/screening-breast
10. ^ National Cancer Institute, "Cancer Stat Facts: Ovarian Cancer", N/A, N/A, 2018, Available: https://seer.cancer.gov/statfacts/html/ovary.html
11. ^ Cancer Research UK, "Ovarian cancer statistics", N/A, N/A, N/A, Available: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer
12. ^ NHS England, "Diagnosis - Polycystic ovary syndrome", N/A, N/A, October 2022, Available: https://www.fertstert.org/article/S0015-0282(08)00975-8/fulltext
13. ^ Cancer Research UK, "Saving lives, averting costs - An analysis of the financial implications of achieving earlier diagnosis of colorectal, lung and ovarian cancer", N/A, N/A, September 2014, Available: https://www.cancerresearchuk.org/sites/default/files/saving_lives_averting_costs.pdf
14. ^ NHS England, "NHS urges women to book a cervical screening as a third don’t take up vital offer", N/A, N/A, January 2023, Available: https://www.england.nhs.uk/2023/01/nhs-urges-women-to-book-a-cervical-screening-as-a-third-dont-take-up-vital-offer
15. ^ Hawkes, N., "Cancer survival data emphasise importance of early diagnosis", BMJ, (8185), p.l408, January 2019, Available: https://doi.org/10.1136/bmj.l408