Team:Rochester/Implementation
UteRus
Implementation
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Women with Endometriosis
Our project aims to influence health care and diagnostics for women with endometriosis, particularly women still struggling to receive recognition of their symptoms.
Endometriosis goes unheard. By spreading awareness through infographics, brochures, and our website to educate people about endometriosis, we aim to give women control back over their health and reduce stigma surrounding women’s reproductive illness.
Endometriosis doesn’t discriminate (Viganò, 2004). By creating a low cost diagnostic tool, we strive to enable women around the world to receive proper diagnosis, regardless of background, culture or geographic location.
Endometriosis is painful. By considering the physical symptoms and experiences of women with endometriosis, we seek to ensure comfort for those using our products.
Our project aims to influence health care and diagnostics for women with endometriosis, particularly women still struggling to receive recognition of their symptoms.
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Physicians and Clinics
Our project aims to enable physicians to recognize the symptoms of endometriosis and provide empathetic and quality care to this patient population.
Physicians are often uneducated on the severity and prevalence from endometriosis (Dr. Ashley Gubbels, June 2020, Personal Interview, Dr. Idahliz Flores, June 2020, Personal Interview). By creating materials that review endometriosis clinical assessment strategies and pathophysiology, we hope to provide physicians with a deeper understanding of endometriosis.
Clinics around the world vary in the resources available to conduct diagnostic tests. By designing low cost and easy to use diagnostic tools, we aim to enable accurate diagnostic testing throughout diverse clinical settings.
Our project aims to enable physicians to recognize the symptoms of endometriosis and provide empathetic and quality care to this patient population.
It’s like a story…
A woman who constantly complains about severe pelvic pain finally feels heard when she goes to a clinic that not only utilizes our diagnostics tools and educational materials, but has empathetic doctors that are knowledgeable about the sign of endometriosis. When she arrives at the clinic, our educational material is surrounding her. From our brochures at the front desk to the walls plastered with our infographics, she is able to not only learn about endometriosis but feels more comfortable discussing her symptoms. She sparks a conversation with her doctor leading him to use our clinical predictive to determine the likelihood of the woman having endometriosis. Based on the results, she is handed our menstrual cup specifically designed for endometriosis patients. On her next period she puts our menstrual cup to use, collecting her menstrual effluent and using our syringe system to secure the effluent in a vial. She brings the vial back to the clinic where the sample is processed with our DIY centrifuge. The sample is run on our non-invasive test strips enabling the doctor to rapidly test for the disease.
Imagine it. She avoided 11 years of chronic, debilitating pain (Agarwal et al., 2019). She didn’t have to frequently miss work or school (Fourquet et al., 2011). She got to spend more quality time with friends and family. She didn’t have to feel alone or misunderstood.
Our Promotinal Video
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Audio Description of Promotional Video
The logo for the organization “iGEM” has appeared on the screen. The logo is a cartoon image with a green gear on the right and a green bacteria on the left.
The video begins as a black and pink cartoon animation.
In big, black letters, the word “Endometriosis” appears on the screen. Underneath it reads: “A production by: University of Rochester iGEM Team”. A teenage female with light hair pulled into a low ponytail is sitting at a desk in a high school classroom holding a phone.
“Meet Eddie.”
Suddenly, Eddie drops her phone and wraps her arms around her stomach. Eddie is biting her lip and appears distressed.
Right now she is sitting in her health class but is too distracted by her intense period cramps to pay attention.
A dark pink school bell appears on the screen and rings shown by lines that represent vibrations of the bell.
Eddie is in the school hallway with lockers on the wall in front of her and a classroom door behind her. Eddieis talking to her friend, who is a female with long hair.
After class, Eddie tells her friends that she is thinking of going home because she is in too much pain.
The friend has an annoyed facial expression and is crossing her arms.
Her friends remind Eddie that she constantly uses this excuse to miss school. They tell Eddie that cramps are normal.
Eddie is sitting in a doctors office, across a table from a male doctor with dark short hair that is combed over a bald spot. There is a scale on the left side of Eddie, a clock on the right side, and a stethoscope on the table. Eddie shrugs her shoulders.
Once again, Eddie tells her pediatrician about her constant cramps and heavy periods but unsurprisingly, he dismisses her.
One by one, five orange medication bottles continue to appear on the table and the clock is winding through time. Eddie’s hairstyle continuously changes as her face appears to be getting older. The physician sitting in front of Eddie is also changing indicated by the changing of hairstyles. Eddie appears increasingly tired and stressed.
And that’s how it went. Medication after medication, doctor after doctor, Eddie still feels unheard.
A bright pink uterus appears with purple growths growing all over it.
So what’s happening to Eddie? Eddie is now in a new doctors office sitting at a table across from a male doctor with short, dark hair. There is a clock on the right side of the wall and a sign that says “Normal Period?” on the left side.
After struggling with infertility, she finally meets a doctor that recognizes her pain.
The doctor believes Eddie is suffering from endometriosis, a chronic disease characterized by uterine tissues growing outside the uterus. However, the doctor cannot confirm her suspicions without surgery.
A pause button appears at the center of the screen.
This is the story of 1 in 10 women. But it doesn’t have to be.
A rewind button appears at the center of the screen as the animation rewinds to the opening scene of Eddie sitting in a high school classroom desk. A play button appears.
Let’s change the narrative.
Eddie, a fair-skinned teenage female with light brown hair pulled into a low ponytail and a yellow shirt is sitting in a green high school classroom desk holding a phone.
Suddenly, Eddie drops her phone and wraps her arms around her stomach. Eddie is biting her lip and appears distressed.
A dark pink school bell appears on the screen and rings shown by lines that represent vibrations of the bell.
Eddie is in the school hallway with yellow lockers on the wall in front of her and a classroom door behind her. Eddie is talking to her friend, who is a fair-skinned female with long black hair and a light blue dress.
This time, Eddie’s friends are concerned about her pain. They mention that these symptoms sound similar to endometriosis, which they had just talked about in health class.
Eddie is back in the doctor's office with pink walls covered with three brightly colored infographics that describe abnormal periods and endometriosis.
One infographic has a bright pink uterus with purple lesions and red streaks. The purple lesions are labelled as “growth” and the red streaks are labelled as “inflammation”
Eddie sees an infographic in her pediatricians office for endometriosis and remembers the support from her friends.
There is a pink brochure labelled “Uterus” on the table. Eddie opens the brochure. The left page has the UteRus team logo on the top of the page with text: “Who are we? University of Rochester iGEM team!”. The brochure has three bullet points on the right page that read, “Non invasive diagnosis, endo education and unique menstrual cups.”
Eddie has a conversation about endometriosis with her pediatrician.
There are four brightly colored infographics about endometriosis signs and symptoms. There is a fair-skinned female with short brown hair standing, a fair-skinned male with short, black hair sitting and a fair-skinned female with light blond hair on her hands and knees. The three people are surrounding pink papers labelled “Endo”. The word “Infographic” is in big black letters.
Because of an earlier diagnosis, Eddie was not only able to manage her symptoms, but she was also able to have children.
A tall fair-skinned male with short Black hair is placing a purple menstrual cup into a container labelled “UV”, which stands for ultraviolet light. A female with long, brown hair is placing a test tube into a centrifuge. A fair-skinned female with long black hair is holding a menstrual cup. The word “Hardware” is in big black letters.
The scene transitions to show three white females are surrounding a lab bench. One has blonde hair in a ponytail and is holding a phone. Another girl has short brown hair and is holding a test strip. The test strip is enlarged to show “Lateral Flow assay” basic design. The last girl has wavy black hair and is pipetting into a petri dish. The petri dish is enlarged to show a bacteria plasmid. The word “Wet lab” is in big black letters.
The pediatrician performs a risk assessment using a simple survey and minimal lab equipment to run a diagnostic panel to determine Eddie’s likelihood of having endometriosis.
Two students, a dark-toned male and a light-skinned female, are each sitting at a laptop. A fair-toned girl with brown hair is standing next to them. There are math equations surrounding the three people as well as graphs. The word “modeling” is in big black letters.
Through iGEM, Team UteRus from the University of Rochester is creating these tools to rewrite the narrative.
There is a 6 panel brochure opened with three panels showing. Each panel talks about endometriosis signs and symptoms for adolescents, adults, and post-menopausal women.. A female with long black hair is peaking her head out of the left side of the brochure. The word “Education” is in big black letters.
Many endometriosis patients don’t feel heard, and we want them to know that we’re listening.
A large team UteRus logo appears on the screen surrounded by 5 team members. The slogan “Let’s take it back from Endometriosis!!!” also appears on the screen underneath a clock that reads “It’s time”. Every letter is black except for the U and R in the uterus which are pink and the word endometriosis which is also pink.
It’s your UteRus, it’s time to take it back from endometriosis.
Future Directions
Bacterial production of antibodies can drastically reduce the cost of immunoassays while build-it-yourself centrifuges lend themselves to use in medical settings with limited funding. We hope that creating these methods will also provide future directions for iGEM teams looking for low cost alternatives to current diagnostic methods for endometriosis and other under researched diseases. Additionally, as more research becomes available regarding endometriosis biomarkers in menstrual effluent, we hope that teams will design innovative endometriosis diagnostic tools that are even more sensitive and specific.
In order to successfully implement our project in the real world, we decided to consider current issues in society that may create barriers to the implementation of our project. To do this, we analyzed the United Nations’ Sustainable Development Goals and designed our project to address challenges relevant to endometriosis and women’s reproductive healthcare.
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Goal #3: Good Health and Well-Being
Governments and private enterprises disproportionately distribute resources, prioritizing certain diseases while undervaluing other prevalent diseases. Endometriosis is one such overlooked disease, affecting at least 10% of women worldwide (As-Sanie et al., 2019). This disease affects not only women's physical well-being but also mental health as approximately 86.5% of patients with endometriosis have depressive symptoms (Sepulcri & do-Amaral, 2009). The combination of symptoms with the astounding 11 year diagnostic delay (Agarwal et al., 2010) negatively impact patients’ daily activities such as work, school, intimate relationships, and social lives, for a significant portion of their lives.
Understanding how the diagnostic delay exacerbates the impact of endometriosis inspired our team to implement our project not just at gynecological clinics but also at pediatric primary care providers, who often lack training on the clinical presentation of endometriosis (Moen, 2017). We aim to make our diagnostics tools available to pediatricians as well as provide pediatricians with information on how to detect the early signs of endometriosis in adolescents. Additionally, we created brochures targeting pre-teens and teenagers to educate them on normative versus atypical period symptoms.
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Goal #4 Quality Education and Goal #5: Gender Equality
Many women experience microaggressions and bias in clinical settings as women’s pain is minimized and considered “over-reactions” (Freeman & Stewart, 2018, Young 2019). These experiences strain the patient-provider relationship as physicians view women as incapable of giving knowledge about their bodies and women, in turn, feel misunderstood and unheard (Freeman & Stewart, 2018). This is particularly relevant to endometriosis patients as the most common symptom is moderate to severe pelvic pain, which may be marginalized by physicians who have minimal training in female reproductive healthcare (DiVasta, 2018, Young 2019).
Marginalizing patients with endometriosis and overlooking their symptoms has been a big issue for patients that suffer from this disease (Grogan et al., 2018, Young 2019). Successful implementation of our diagnostic tools relies on physicians knowing when to use them and women advocating for a test to be done even when physicians minimize their symptoms. Our project aims to empower women to spark conversations with their physicians about their pain and advocate for themselves. To accomplish this, women must be educated on the sign and symptoms of endometriosis and be confident in their knowledge of their own menstrual health. Additionally, physicians must be educated on how to provide empathetic and quality care to women who experience pelvic pain. We launched an outreach program designed to target women of all ages and physicians who may be exposed to endometriosis patients. We distributed these infographics and brochures to local clinics and created an educational website with the hopes of inspiring women to self-advocate.
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Goal #10: Reduce Inequalities
Endometriosis affects at least Comment start 200 million people worldwide (Eskenazi & Warner, 1997) Comment end demonstrating that this is a global issue. However, access to healthcare, specifically women’s healthcare, and the quality of care varies significantly across countries due to differences in available resources and diverse cultures surrounding women’s reproductive health.
By utilizing E.coli for the production of antibodies in our diagnostic panel, we considerably reduced the cost of our test making it thousands of dollars cheaper than the cost of invasive laparoscopic surgery for diagnosis (Fuldeore et al., 2011). Our test can also be done with minimal equipment and training by healthcare providers or technicians. Between the ease of use and reduced cost, we aim to be able to implement our project in all clinical settings, despite the clinic’s access to medical resources or the financial status of the patient. However, it is also important to collaborate with the communities we plan on implementing our project in to discuss how we can adapt our product and educational materials to meet the unique needs of the individual community.
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Goal #12: Responsible Consumption and Production
While tampons and pads remain the most popular menstrual hygiene products in developed countries, their single-use nature and plastic non decomposable composition leads to build up of these products in landfills and increases microplastics in the ocean (Peberdy et al., 2019). Menstrual cups are environmentally friendly alternative to tampons and pads as a single cup can be reused for up to 10 years. However, only a small percentage of women use menstrual cups due to lack of education on menstrual cups and general public familiarity with them (Van Eijk et al., 2019).
When designing our menstrual blood sample collection kit, our team decided to utilize menstrual cups due to their sustainability. However, knowing that most women prefer single-use disposable menstrual hygiene products, we focused our outreach on promoting the benefits of menstrual cups and how to properly use them in order to increase women’s comfort and confidence with menstrual cups.
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Goal #17: Partnership for the Goals
According to the United Nations, successful implementation of solutions that address the sustainable development goals requires strong partnerships among groups that share the same vision. Throughout our project, we partnered with endometriosis and women’s health foundations, organizations, and manufactures in the U.S., U.K., Denmark and India who are also working towards sustainable and globally accessible solutions to the lack of research and awareness of endometriosis. With their guidance, our team was able to design a diagnostic panel, menstrual blood collection kit, and laboratory equipment that can be used across various cultures and socioeconomic backgrounds. Additionally, we were able to create educational materials that are accessible to people from diverse backgrounds and spread materials to physician practices in the USA; online versions were posted on social media and websites from various collaborators that can be accessed and downloaded worldwide.
Through continued partnerships with these and similar organizations, our team will be better able to globally implement our project as it will be informed by the needs of various stakeholders world-wide.
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Centrifuge
Electrocution, sample leakage, and tube ejection were considered when designing the centrifuge. Our centrifuge only requires 5V, meaning the possibility of electrocution is extremely low even in the case of circuit shortage. Additionally, we added a plexiglass case around the centrifuge rotor so that if samples are misplaced in their socket, they cannot spill outside the centrifuge and no projectiles would be created from the rotations speed.
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UV Sanitizer
Direct exposure of flesh with the UV light from the sterilizer could cause artificial sunburns. As such, we decided to use ar-UVC light (207–222 nm) which is likely not harmful if exposed to human tissue. During the development stage, safety was considered in the hardware design including the use of a contact switch to ensure the device is only turned on once the cap is closed and a water leakage test to ensure that the sterilizer is fully sealed and no liquid could touch the electronic components. To further ensure safety we will be providing clear user instructions on how to use as well as warnings to not put fingers or eyes inside the sterilizer.
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Menstrual Cup
The first safety aspect that many practitioners and specialists pointed at was using medical grade silicone for the cup’s material. There are some risks that are associated with inserting hygiene products in the vaginal canal. The one we focus our effort on is Toxic Shock Syndrome, or TSS. TSS is typically caused by two specific strains of bacteria- Staphylococcus aureus and Group A Streptococci. Our proposed method of reducing the risk of TSS is using an UltraViolet light sterilizer that can remove the bacteria more efficiently from the cup between uses compared to washing it using soap or sterilization using boiling water.
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Diagnostic Panel
The laboratory and clinics that request the diagnostic tool kits will receive the test strips preassembled, meaning that there will be no biochemical experimentation required on the part of the users. Sample collection and preparation will be done following the proper biohazard safety level guidelines. These guidelines were developed by the Environmental Health and Safety at the University of Rochester, outlining proper protective equipment for handling and disposing of biological specimens. Minimal laboratory equipment will be required for five of the six biomarkers, while a more intensive isolation process will be required for IGFBP-1.
The IGFBP-1 assay is recommended to be performed in a more developed laboratory setting. Even though the majority of the diagnostic panel can be carried out with minimal equipment, it is possible to run the diagnostic panel excluding IGFBP-1. Sample collection and serum separation carry minimal risk of hazard if using the proper protective equipment and proper disposal of biological waste. The gold enhancement solution will be provided in the kit at minimal volumes that should also pose minimal risk through the use of personal protective equipment. There are no risks associated with the physical test strip. We recommend the use of a biosafety level-2 industrial lab for the mass production of antibodies in E. coli.
When implementing our project, we have to take into account realistic constraints within our society.
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Lack of therapeutics
Providing a noninvasive diagnostic for endometriosis is important, but unfortunately, it may not have a significant impact on patient care. Even with a reliable diagnostic tool, there are limited treatment options available for endometriosis and most medications focus on symptom management and menstrual suppression.
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Lack of medical intervention in under-served areas
The question of whether it is ethical to provide a patient with a diagnosis that they are unable to treat is a controversial challenge to address. The social issue of diagnosing endometriosis in under-served areas that could lack any treatment or management options may increase the burden of the family instead of increasing the quality of life for patients. Additionally, providing a voice to women in underserved communities, who may not have access to physicians who were educated about endometriosis, presents a great challenge. The production of educational material and the use of limited lab equipment for the development of our design was taken into account but, we would need to develop more in-depth outreach programs for these communities in order to overcome these challenges.
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