We hope to collaborate with local clinics or healthcare institutions in the future and establish testing stations in these locations. Through blood sampling and the use of fully automated equipment, we will measure the concentration of Circular RNA in the blood (interpreted in nanogold assay), with the entire process yielding test results in approximately two hours.

Regarding the PCRD screening aspect, we aspire to follow a similar approach to COVID-19 rapid testing by making rapid test kits and testing reagents available for purchase at pharmacies or clinics for individuals who require testing. If individuals receive a positive rapid screening result with three lines during testing, they should seek further medical diagnosis and help at the hospital.

Click to go Hardware!

According to the statistics on medical and healthcare expenses for cancer patients in Taiwan in the year 2022, as shown in Figure 1, there were 110,579 patients who sought medical treatment for colorectal cancer (including colon, rectal, and anal cancer). The pharmaceutical expenses covered by National Health Insurance (NHI) amounted to approximately NT$5.67 billion New Taiwan Dollars, while the total medical expenses incurred reached NT$16.07 billion New Taiwan Dollars. On average, each patient incurred about NT$51,287 New Taiwan Dollars in pharmaceutical expenses and NT$145,284 New Taiwan Dollars in total medical expenses.

According to a report from MARKETSANDMARKETS, the global cancer diagnosis market size in 2021 was $17.2 billion USD. It is projected to reach $29.6 billion USD by 2026, growing at a Compound Annual Growth Rate (CAGR) of 11.5%. The majority of the market, accounting for 67%, is comprised of equipment, including Pathology-based Instruments, Imaging Instruments, and Biopsy Instruments, as illustrated in Figure 2.

Figure 1. Cancer Epidemiology in Taiwan (Ministry of Health and Welfare - Statistics of Pharmaceutical Expenses and Medical Costs for Cancer Patients in 2022)

Figure 2. The Market Size of Cancer Screening (MARKETSANDMARKETS(2021/04) Cancer Diagnostics Market worth $26.6 billion by 2026)。

    Purpose

With the purpose of meeting the needs of the public and ameliorating the current condition of detecting early-stage Colorectal Cancer, our team designed a survey to investigate the severity of colorectal cancer worldwide and the acceptable price range for cancer screening among the general public. The questionnaire reflected the public's thoughts on our product and how they felt about current methods of detecting early-stage Colorectal Cancer.

    Analysis

The result data showed that there were over four hundred people joined this investigation, and the composition of the respondents ranged from college students to workers, medical-related industry, professors, and others. The age of the respondents ranges from less than 18 years old to over 60 years old. From the data, we can summarize a few important points as follows:

1. Colorectal Cancer is common and serious:

> According to the database, there are 84.8% of the respondents considered Colorectal Cancer to be common and serious while 8.6% of them considered Colorectal Cancer to be common but not serious. And only 1% of the respondents think Colorectal Cancer is not common or serious.

2. Colorectal Cancer could cause inconvenience to life:

> According to the database, there are 98% of the respondents think having Colorectal Cancer is a tragedy to life and only 1% consider the disease to have no impact on life.

3. Current fee for detecting Colorectal Cancer is too expensive:

> Even though Taiwan has health insurance, there are still over half (52.1%) of the respondents consider the cost of detecting Colorectal Cancer to be too high for the general public, not to mention countries that do not have health insurance!

4. Current detecting method(such as FIT) is inconvenience:

> According to the database, there are 76% of the respondents think the current method of detecting early-stage Colorectal Cancer is way too inconvenient.

5. NanoCircDx is acceptable to the public:

> According to the database, 96.3% of the respondents are willing to use our product for early detection of Colorectal Cancer due to its convenience, accuracy, minimal invasiveness, and efficiency. And only 2.7% of the respondents don’t have to will to use our product.

    Realistic Milestone

1. Find the problem of early-stage detection of Colorectal Cancer.
2. Brainstorm the solution to the problem—NanoCircDx.
3. Inquire for professional and industrial advice.
4. Take the public's thoughts into consideration.
5. Improve our product.
6. Meet the needs of the public.

    Product Development Plans

4P Model

Based on the MARKETSANDMARKETS report, the global cancer diagnosis market is projected to reach a substantial value of $29.6 billion by 2026. Our product leverages cutting-edge liquid biopsy technology, offering a solution that addresses the limitations commonly associated with existing methods, such as invasiveness and inconvenience, as supported by public survey feedback.

In the realm of marketing, our pricing strategy stands out as a key component. Our product boasts affordability when compared to traditional colonoscopy procedures. Patients are only responsible for covering the registration fee and associated blood testing costs. Moreover, our fully automated equipment substantially reduces hospital labor costs, thereby lightening the load on the healthcare system.

In terms of promotion and placement, our ongoing product development efforts align with collaborative ventures with local clinics and healthcare institutions. We aspire to have a significant impact on the field, ultimately contributing to the preservation of lives. This integrated approach, encompassing the 4Ps of marketing (Product, Price, Promotion, and Place), positions us to make a meaningful difference in the cancer diagnostics market.

Figure 3. 4P Analysis of NanoCircDx

    SWOT Analysis

Figure 4. 4P Business Analysis - SWOT Analysis

SWOT Analysis

From a strengths perspective, the research product emphasizes a novel exosome-based colorectal cancer detection system (prognosis) with high sensitivity, specificity, precision, and cost-effectiveness. This positions it in the market as a differentiated product in terms of technology and product attributes compared to existing methods, which is a competitive advantage for the research team. Furthermore, the research team possesses core technology expertise and has established relevant patents, along with control over key raw materials and suppliers, which provides a significant advantage in terms of product ownership and know-how.

However, internal weaknesses include the fact that the current methods are well-known in the clinical field, making it costly to “teach users" about the research product when entering the market. Additionally, this technology product requires integration with its own sensing devices, which involves a bundled sales approach of instruments with testing reagents. This aspect needs to be carefully considered in the subsequent marketing strategy. Simultaneously, the research team is a startup and lacks brand recognition and corporate visibility, which will require substantial resources in the marketing efforts when entering the market through distribution channels.

External opportunities in the market, based on data analysis in this study, indicate that there is still a need for more effective ways of applying liquid biopsy in cancer detection within the clinical setting, and there is a high level of expectation for liquid biopsy in the market. Analysis of competitors also reveals that international companies are still in the development stage for exosome diagnostics, and non-invasive testing is currently the primary trend in the market. All of these factors present opportunities.

Furthermore, by the research, it can be observed that major corporations or self-developers are currently at the nascent stage of exosome diagnostics. Only one American company is active in clinical applications. However, when considering the broader context of liquid biopsy, there are already products and services on the market in areas such as CTC and ctDNA.

External threats in the market consider that exosome technology is still in its infancy, and thus, if the team possesses critical core technology, it needs to seize the initiative in development. Additionally, healthcare distribution channels are closed, and the barrier to entry for new products into these channels is high.

    Future Work

The ultimate goal of our project is to raise awareness of early colorectal cancer screening among the public. The fastest way is to popularize and commercialize our project as soon as possible. The following will be some brief introductions to the different works and goals we planned to meet during the process of implementing our project.

1. Issue a paper

When we came up with the project and prepared experiments, we referred to many papers and suggestions from professionals in different fields. Therefore, after completing the competition, we will publish our project as a paper to help future iGEMers and other scientists who want to use circRNA to screen cancer.

2. Apply for product patent

Nowadays, the world pays more and more attention to intellectual property rights. Applying for patents for our products is a good way to protect the intellectual property rights of creators and at the same time protect the rights and interests of consumers. It ensures the quality and source of products. Enable consumers to trust the goods or services they purchase.

    POSITIVE:

1. Reduce the burden of the NHI

If our project is successfully developed into a commercial product, it will be very helpful to the National Health Insurance of our country (Taiwan) and can greatly reduce the burden of the National Health Insurance.

Taiwan's healthcare system, called National Health Insurance (NHI), makes sure everyone gets affordable, high-quality medical care. It's like a big insurance plan run by the government.

2. Increase willingness to get cancer screening

3. Potential market demand

Colorectal cancer is a common cancer worldwide, so there is a huge potential market demand, especially for new technologies for early screening.

4. Impact on medical research

The successful development of such reagents will have a profound impact on medical research and clinical practice and is expected to improve the early detection rate of colorectal cancer.

    NEGATIVE:

1. Requires more resources and takes a longer time

Developing new medical reagents requires significant time and resources and requires rigorous regulatory and approval procedures, which can be a long and expensive process. In addition, the development of rapid screening reagents requires highly sensitive and specific technologies to ensure accuracy and reliability, which may be part of the technical challenges.

2. Cost and availability

Making new screening tests more widely available requires large-scale production and distribution, which can involve high costs, especially in the early stages.

Go to Integrated Human Practice page to see more!

Click to go IHP!

In order to raise funds for our experimental research, community outreach initiatives, and various expenses associated with the 2023 iGEM competition, we have been actively seeking scholarships and reaching out to the public for donations, as well as proactively seeking sponsors. Thanks to the laboratory project and the sponsorship from various organizations, we believe that every contribution, regardless of its amount, plays a crucial role in supporting our journey.

We heartfully thank Prestigious supports from MOST 109-2222-E-007-003-MY2; NSTC 112-2321-B-007-003; NSTC 112-2221-E-007-019-MY3; SPARK grants@NTHU; MGH FMD Fellowship; NIH T32; APAC Award; MOE STEM grant; NTHU-CGMH joint grants; CMRP grants; NTHU grants; NHRI grant; ITRI BMCC grant; National Tsing Hua University scholarship; Integrated DNA Technologies; Taiwan Ministry of Education scholarship; College of Life Science and Medicine, National Tsing Hua University; NTHU Alumni Association; Taiwan Association For Virtual And Augmented Reality scholarship; iGEM Impact Grant and ongoing applications.

Reference

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[19] Colorectal Cancer Diagnosis Methods - Handy Guide https://www.cmuh.cmu.edu.tw/NewsInfo/NewsArticle?no=5745

[20] Colorectal Cancer Prevention and Screening https://reurl.cc/RvoxEG

[21] How to Properly Screen for Colorectal Cancer https://www.tyh.com.tw/health/f11.html

[22] Introduction to Colorectal Cancer Screening https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=621&pid=1136

[23] Circulating Tumor Cell Detection Introduction - Harvard Health Check https://reurl.cc/X4Z79D

[24] Chang Gung Medical Center Fee Standards https://reurl.cc/Zr4yDW

[25] National Taiwan University Hospital Medical Fee Standards https://reurl.cc/3jKeGl

[26] Beitou Checkup Management Hospital Self-Pay https://reurl.cc/qOG0MN

[27] Shin Kong Wu Ho-Su Interpretation of Examination Results https://reurl.cc/pWa5Q8

[28] Exosome Treatment and Diagnostic Companies Worldwide http://www.xpbiomed.com/newsitem/278546988

[29] Roche and Takeda's Layout: Nearly 50 Companies Compete in the Exosome Industry https://reurl.cc/rLVddO

[30] Bio-Techne Brands https://www.bio-techne.com/cn/about/bio-techne-brands

[31] Bio-Techne Investor Presentations https://investors.bio-techne.com/presentations

[32] How Exosome Diagnostics Became a Benchmark in the Exosome Diagnostic Industry https://www.vbdata.cn/38851

[33] Exosome Liquid Biopsy Achieves Breakthrough, ExoDx Prostate IntelliScore Granted Breakthrough Medical Device Designation by FDA https://xueqiu.com/1912517390/128531591

[34] ExosomePlus http://www.exosomeplus.com/