Implementation
Practical approach for early detection of cervical cancer
CEApture — Sanitary Pad, easy and early cervical cancer diagnosis
By attaching a biosensor to sanitary pads and adult diapers, we move away from the conventional cervical cancer diagnostic kits. This allows easy early detection of cervical cancer through line exhibition.
What is CEApture-Pad?
Based on our CEApture project, we envision the creation of a CEApture pad. CEApture-Pad is a sanitary pad embedding CEA protein-detecting biosensors. Women will use these sanitary pads regularly. When vaginal fluid or menstrual blood is absorbed by the pad, it comes into contact with the biosensor. The biosensor is designed to identify specific biomarkers, such as the CEA protein, present in the fluid, resulting in a visible line exhibition. Women can easily observe this two-line positive at home, enabling them to monitor and determine the potential development of cervical cancer.
Within the female reproductive system, a significant amount of cervicovaginal fluid (CFV) is produced. In contrast to menstrual blood, CFV is generated in postmenopausal women as well. This concept inspired us to engineer a biosensor for diagnosing cervical cancer by detecting the CEA protein, a biomarker present in CFV. The biosensor will utilize a paper-based lateral flow assay (LFA) similar to the methodology used in COVID-19 rapid antigen test kits or the PURE system. Utilizing CFV for diagnosis allows for potential integration into urinary incontinence pads, enabling menopausal women, regardless of their menopausal status, to utilize it for the early detection of cervical cancer.
CEApture-Pad Design
The CEApture-Pad is composed of three layers:
◦ The Cover Layer: This layer is in direct contact with the body and securely attaches to undergarments. ◦ The Menstrual Blood Absorption Layer: The biosensor is embedded in this layer ◦ The waterproof layer
The biosensor attaches to the middle menstrual blood absorption layer. This positioning allows the biosensor to detect substances in vaginal fluids without direct contact with the user's skin, ensuring safety. When the biosensor detects the presence of CEA protein within the absorption layer, it triggers a two-line positive response. This two-line indication can be observed by detaching the sticker on the side that attaches to the outermost layer.
More specifically, the side of the pad that attaches to undergarments is waterproofed to prevent menstrual blood from permeating through. A transparent film and a removable sticker are attached to the center of this side. Users can remove the sticker from the sanitary pad after menstrual blood has been collected. Once removed, either one or two lines become visible through the transparent film. The presence of two lines indicates the potential risk of developing cervical cancer. The interpretation of the two lines will be explained either on the product packaging or in an accompanying instruction manual provided with the product.
Who & Where: Target Audience and Market
According to the World Health Organization's 2020 statistics, cervical cancer is the fourth most common cancer in women globally, with a higher incidence in low and middle-income countries, leading to fatalities. [1] Based on the statistics from the Ministry of Health and Welfare, Every year, over 570,000 women worldwide are diagnosed with cervical cancer, and about 310,000 women lose their lives to this disease. [2] This translates to one woman dying from cervical cancer every two minutes, making cervical cancer one of the most significant threats to women's health. The prevalence of cervical cancer among young women aged 20-39 has been increasing, particularly in the 20-30 age group, constituting more than 10% of female cancer cases in that age range. This emphasizes the growing demand for cervical cancer screening, necessitating regular check-ups and effective management due to the high recurrence risk even after successful treatment.
Presently, a self-diagnosis kit for cervical cancer has gained significant market traction after FDA approval. Sanitary pads are essential products for women, constituting a large market in itself, primarily focusing on disposable pads in the Korean market. By integrating a biosensor capable of diagnosing cervical cancer into disposable sanitary pads, we can merge disease diagnostics with the sanitary pad industry, generating substantial revenue.
As part of welfare initiatives, sanitary pads with embedded cervical cancer diagnosis biosensors could be distributed to socioeconomically vulnerable women. Collaborating with menstrual pad donation campaigns like Good Neighbors and Sharing Love Field would not only involve pad donations but also enable affordable and regular cervical cancer diagnostics. This initiative could significantly enhance the ability of vulnerable women, especially those in their 20s to 30s, to monitor their health for cervical cancer conveniently and affordably.
Why?
The primary symptom of cervical cancer is vaginal bleeding, often mistaken for menstrual bleeding. Early-stage cervical cancer typically doesn't exhibit symptoms, making timely diagnosis challenging. Vaginal bleeding indicates significant progression, stressing the urgency of diagnosis and treatment. The 5-year relative survival rates highlight the importance of early detection, underscoring its global significance.
Regular screenings are pivotal for early detection, yet they can be costly and inconvenient. Current diagnostic kits offer a more accessible option but require sending samples to a lab and a subsequent hospital visit for results. Embedding biosensors in sanitary pads presents an affordable, convenient solution. These biosensors enable proactive health management through immediate color changes, signaling potential cervical cancer. Utilizing a 'cell-free system' ensures safety and boosts consumer confidence. Sanitary pads with biosensors promote active health monitoring for all women, regardless of their economic status.
How?
User Guide
| Step 1 | Remove the sticker on the outermost layer. |
|---|---|
| Step 2 | Observe line appearance according to the guidance |
| Step 3 | Throw into the garbage according to regulations. |
Interpreting Result
| Clear Two Lines | High possibility of cervical cancer development. Checkup is required. Visit a nearby hospital. | Ambiguous lines | High possibility of cervical cancer development. Checkup is required. Visit a nearby hospital. |
|---|---|
| Only 1 line | Low possibility of cervical cancer development. Checkup is recommended for confirmation. |
Business Plan
After consulting with experts, a detailed plan was crafted to realize the project. Beyond the iGEM competition, the goal was to continue the research and translate it into a commercial venture benefiting many. A comprehensive business plan was devised, and essential information was gathered to kickstart the project swiftly. In addition to product development, various aspects were carefully considered, including the business model, government engagement, and distribution with government support.
The approach involves a detailed strategy for sanitary pad sales. The choice was a B2B sales model, collaborating with sanitary pad manufacturers to produce and distribute biosensors. We designed and produced the biosensor, leveraging expertise in cervical cancer diagnostics. The plan is to contract with sanitary pad manufacturers to provide them with biosensor-embedded sanitary pads. This collaboration allows for the effective initiation of sanitary pad sales. Furthermore, a plan has been outlined to secure exclusive production rights by applying for biosensor patents through the Korean Intellectual Property Office, essential for establishing a successful business.
This is a brief 3-year business plan for the project-based product. The specific plans are as follows:
| Timeline | Goals |
|---|---|
| Quarter 0 | Confirm marketability |
| 1st Quarter [1 year] | Biosensor production and verification |
| 2nd Quarter [5 months] | Collaboration agreement signed with sanitary pad production partner |
| 3rd Quarter [3 months] | Sample production and testing |
| 4th Quarter [7 months] | Prototype production |
| 5th Quarter [1 year] | Issuance of a permit (certificate) conforming to medical device manufacturing and quality control standards |
| 6th Quarter [1 year] | Establishment and implementation of the pre-market advertising plan |
| 7th Quarter [1 year] | Start of marketing |
| 8th Quarter [1 year] | Reflection of user reviews and formation of a stable B2B supply chain |
Diverse Aspects
[Economic Impact - Local]
The integration of biosensors into sanitary pads positions it as the pioneering functional sanitary pad for immediate cervical cancer diagnosis within South Korea's 500 billion KRW sanitary pad market. This innovation is expected to significantly impact the market, considering that the domestic market for sexually transmitted disease diagnosis amounts to approximately 80 billion KRW, with the HPV-related diagnostic market constituting about 60 billion KRW.
The Ministry of Food and Drug Safety has disclosed that the market size of sanitary pads amounts to approximately 300 billion Korean Won, underscoring the extensive utilization of sanitary pads within the market. [3] Not limited to Korea, there is a significant global consumer base for sanitary pads. The global market size for sanitary napkins achieved a valuation of US$ 25.6 billion in 2022. Additionally, the market is expected to reach US$ 34.0 billion by 2028. [4] This reveals that this product has potential consumers not only locally, but also globally.
The primary customers, accounting for over 90% of the market share, are the top five sanitary pad companies. For companies seeking innovative and safe sanitary pad ideas aligned with women's preferences and emphasizing stability, the biosensor-integrated sanitary pad presents an attractive option. Yuhan-Kimberly, in particular, has shown a keen interest in investing 1.43 trillion KRW to pioneer new growth avenues and innovative product supply bases. Their investment aligns with the national trend of bioscience development, aiming to offer differentiated employment opportunities. These factors may further indicate its global product potential.
[Societal Impact]
Engaging with Youth sanitary pad support activity allows us to address health and welfare challenges within underserved communities, creating a positive impact at the local level and garnering public attention. Positioning this innovation as an effective means to alleviate concerns about sexually transmitted diseases, in tandem with public interest campaigns for HPV vaccination, amplifies awareness of related conditions while promoting women's health. Additionally, introducing the concept of commercializing diagnostic kits in a sanitary pad-sized format, akin to self-diagnostic COVID-19 kits, not only holds promise for immediate cervical cancer diagnosis but also paves the way for potential expansion into diagnosing various other diseases.
Further Challenges and Improvements
Implementation Challenge
1. Biosensor Integration and Stability Integrating the biosensor into the sanitary pad while maintaining its stability and functionality throughout the pad's lifespan and surrounding environment, including during storage and use.
2. Manufacturing Scalability and Cost-efficiency Developing a cost-effective and scalable manufacturing process to produce biosensor-embedded sanitary pads at a large scale to meet market demand.
3. User Acceptance and Education Ensuring that users understand the purpose and usage of the biosensor-embedded sanitary pad, addressing any concerns or misconceptions related to its use and effectiveness.
Vector Development of CEApture
According to the template DNA designed for CEA N domain expression, the CEA N domain sequence was integrated into the pET-28a(+) vector. Post-cell-free expression experimentation, enhancements to the template DNA were made utilizing iGEM parts to boost protein expression. iGEM components such as T7 promoter, RBS, T7 terminator, and RBS_strong part were incorporated for heightened protein expression levels. This advancement is expected to enhance diagnostic efficacy, particularly for detecting trace amounts of biomarkers within the CFV.
What do we Expect?
We envision our project contributing to broader social goals by fostering collaboration and knowledge sharing within the scientific community. This collaborative approach aims to amplify the positive impact of our innovation and drive advancements in healthcare and diagnostics.
[Community]
1. Enhanced Women's Health Awareness: By providing a simple and accessible tool for early detection of cervical cancer, we can increase awareness about women's health within the local community. Providing education to the public about regular screenings and the importance of early detection can save lives.
2. Affordable Healthcare Access: Making cervical cancer screening more affordable and convenient through CEApture-pad ensures that a broader segment of the local population can access regular check-ups, ultimately leading to early detection and treatment.
3. Support for Vulnerable Groups: Collaborating with sanitary pad support programs can enhance their health and well-being, fostering a sense of community care and support.
4. Job Creation and Economic Impact: As production scales, it has the potential to create jobs in local manufacturing, distribution, and associated services. This can contribute positively to the local economy and enhance the standard of living in the community.
[Scientific Community]
1. Advancing Diagnostics Research: This project contributes to the field of diagnostics and biosensors. The successful development and application of technology can advance research in biosensing and encourage further innovation in diagnostics for various health conditions.
2. Collaboration and Further Innovation: Sharing methodologies and challenges with the scientific community can promote collaboration and knowledge sharing. It can inspire other researchers to explore new interdisciplinary approaches in healthcare and diagnostics. This project can serve as a stepping stone for future research in biosensors, healthcare technologies, and materials science.
Reference
[1] World Health Organization, “Cervical Cancer,” *World Health Organization*, Feb. 22, 2022. https://www.who.int/news-room/fact-sheets/detail/cervical-cancer
[2] World Health Organization, “Cervical Cancer,” *World Health Organization*, n.d https://www.who.int/health-topics/cervical-cancer#tab=tab_1
[3] Ministry of Food and Drug Safety. Status report on female hygiene products and safety information. Cheongju: Ministry of Food and Drug Safety;2017.
[4] IMARC Group, Sanitary Napkin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028, Report ID: SR112023A825