Human Practices
This page demonstrates how our team collaborates among different sectors by involving them in our engineering cycle.
Objectives of Our Project
Our ultimate goal: to create a non-invasive home-use rapid testing kit for CRC that:
aligns with stakeholders’ needs
tackles the weaknesses of current detection methods.
This involves three Key Phases created to promote effective feedback cycles between various stakeholders and our project:
Phase 1: Empathise and define
Identify the significant impact of CRC on the general public
Define and empathise with the needs of key stakeholders
Phase 2: Development and Co-design
Gather critical insights
Develop the project with actionable feedback
Phase 3: Validation and Implementation
Validate our prototype with different feedback
Establish clear adoption pathways
Timeline of Our Human Practice
Background Information on Colorectal Cancer
As our project aims to navigate colorectal cancer (CRC) in terms of diagnosis and detection, we first have to understand the context of the matter.
What is colorectal cancer (CRC)?
Colorectal cancer (CRC) begins in the colon or rectum, parts of the digestive system. It often starts as small, noncancerous polyps that can develop into cancer over time through the adenoma-carcinoma sequence, where benign growths gradually become malignant tumors.[1]
Symptoms may include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss[2]. CRC can spread to other parts of the body through the bloodstream, leading to metastasis and complicating treatment.
Early detection through screening is crucial, as it can significantly improve treatment outcomes and reduce mortality rates, laying the foundation for the development of this quick test paper.
Situation of CRC in Hong Kong
Colorectal cancer (CRC) has resulted in a significant number of deaths, with 2,266 fatalities reported in 2023 alone. Notably, males are at a higher risk compared to females, and the incidence of CRC has shown a steady increase since 1981.
Situation of CRC around the globe
Colorectal cancer (CRC) is the third most common cancer worldwide and the second leading cause of cancer-related deaths. It accounts for approximately 10% of all cancer cases, highlighting its significant impact on global health.
In 2020, there were approximately 1.93 million new cases of colorectal cancer (CRC), resulting in about 940,000 deaths, which reflects a death rate of nearly 49%. Looking ahead to 2040, new cases are projected to rise to 3.2 million, marking a 63% increase, while deaths are expected to reach 1.6 million, representing a 73% increase[5]. CRC predominantly affects older individuals, with the majority of cases occurring in those aged 50 and above.
Therefore, the serious effects of CRC in both Hong Kong and the world laid the foundation for us to develop this quick test paper.
Risk Factors of CRC
Colorectal cancer (CRC) risk factors are a mix of genetic, dietary, and lifestyle elements. Age is a significant factor, with the risk rising sharply after 50. Family history also plays a big role; if one has close relatives who had CRC or polyps, one’s risk increases. Genetic conditions like Lynch syndrome and familial adenomatous polyposis (FAP) can further heighten this risk.
Diet plays a key role. Eating a lot of red and processed meats while not getting enough fruits, vegetables, and fiber can lead to higher chances of developing CRC. Lifestyle choices matter, too. Being inactive, overweight, smoking, and drinking heavily are all linked to an increased risk of the disease.
Additionally, people with inflammatory bowel diseases, such as ulcerative colitis or Crohn's disease, face a greater threat, as do those with a history of polyps or type 2 diabetes.[7]
These dietary and lifestyle factors can lead to cellular mutations, which accumulate over time and can turn into cancer. For instance, smoking can cause a significant number of mutations each year, increasing cancer risk.[8] Regular screenings, healthy eating, and active lifestyles are essential steps people can take to lower their risk of colorectal cancer.
Pros and Cons of Current Detection Methods
There are currently 5 main detection methods for CRC :
Colonoscopy
uses a flexible tube with a camera to examine the inner lining of the colon and rectum
helps detect abnormalities like polyps or tumors
can remove tissue samples
Sigmoidoscopy
allows doctors to look at the lower part of patients’ colon using a flexible tube with a camera
helps identify problems like inflammation, polyps, or tumors
less invasive than a colonoscopy and usually requires only minimal sedation
CT Scan
creates detailed pictures of one’s colon and nearby areas
helps doctors find tumors, see how far the cancer has spread, and check if it has moved to other parts of the body
Faecal Immunochemical test (FIT)
detects hidden blood in stool samples by using antibodies to specifically detect human haemoglobin, which can indicate the presence of polyps or tumors.
easy to use, requires no dietary restrictions
applied in the Hong Kong CRC Screening Programme
Faecal Occult Blood Test (FOBT)
detects hidden blood in stool samples by using guaiac resin.
requires dietary restrictions, more complicated to use than FIT.
lower sensitivity and specificity than FIT.
Overall comparison among current detection methods
- Polyps can be identified and removed during the procedures
- Detailed image
- Cheaper than a colonoscopy
- Easy to use
- No diet restrictions
- Long queuing
- Expensive
- Expensive
- False negative
- False negative
- Requires dietary restrictions
Table 1. Advantages and Disadvantages of the 5 current detection methods
Diagnosis and Treatment
If CRC is diagnosed to be present in the patient’s body by the detection methods above or otherwise, treatments regarding the stage of tumor growth will be carried out. For stages 1 to 3, surgery is used since the tumor can usually be removed. For stage 4, chemotherapy for about 3 to 6 months is mainly used as the tumor has spread. If the cancer is in the rectum, electrotherapy can also be used. Post-surgery monitoring for 5 years will also be pivotal to check the colon for any problems and address any precursors for CRC relapse.
Role of miRNA in CRC
What is microRNA (miRNA)?
MicroRNAs (miRNA) are small non-coding RNA molecules that are crucial in regulating gene expression. They bind to complementary sequences on target messenger RNAs (mRNA), subsequently resulting in either RNA silencing or suppression of translation of mRNA into proteins. This makes them responsible for regulating cell differentiation, cell cycle progression, and apoptosis.[9]
MicroRNA and CRC
In the case of CRC, there would be an aberrant expression of certain miRNAs within the cancer cells, in which the miRNAs either act as an oncogene or a tumour suppressor. Oncogenic miRNAs, such as miR-21, one of the most well-studied miRNA implicated in CRC, target multiple tumours suppressor genes, including Phosphatase and Tensin Homolog (PTEN) and Programmed Cell Death Protein 4 (PDCD4) in the context of miR-21, which leads to cell proliferation, invasion/metastasis, and resistance to apoptosis.[10]
Conversely, other miRNAs function as tumour suppressors by inhibiting oncogenic pathways. miR-34a is another well-known miRNA in CRC which acts as tumour suppressors. It is directly regulated by tumour suppressor p53 and target genes involved in cell cycle progression and apoptosis, including BCL2 apoptosis regulator and Cell Division Protein Kinase 6 (CDK6).
MicroRNA as Diagnostic Biomarkers for CRC
MicroRNAs have promising capabilities to be diagnostic biomarkers for CRC for its high sensitivity and capability, stability in human fluids, and easy detection in non-invasive samples.[12] Most importantly, the dysregulation of certain miRNAs correlated to CRC can be used as reliable biomarkers.
N.B. Certain miRNAs (miR-21, miR-92a) are upregulated while others (miR-125b, miR-139-3p) are downregulated in the presence of CRC. Such dysregulation could be utilised to deem patients at “high-risk of CRC”.
In this project, we would utilise the dysregulation of certain miRNAs to detect CRC. Specifically, miR-135b and miR-92a-3p were proposed as candidate miRNAs for their upregulation in advanced adenoma (AA) and faeces in the presence of CRC.[14][15] In the end, miR-92a-3p and miR-135b-5p were selected as the biomarkers to be used in our kit. How they were selected is summarised in the section “Summary of Our Integrated Human Practice-Why miRNAs?”.
Identification of Stakeholders
High Power - High Interest
Valuable feedback from doctors and healthcare professionals allowed us to strengthen our foundation for the project and streamline the prototype.
High Power - Low Interest
We mainly target patients and high-risk groups. Conducting interviews with them allows us to acknowledge their authentic experiences and possible demands for a CRC fast test kit.
Low Power - High Interest
Their knowledge and interests help us to identify our kit’s clinical positions as well as the potential of our kit in the market.
Low Power - Low Interest
Through interactions with the public, we can collect views about public awareness and their knowledge about CRC screening.
Market Features of our test kit
From the engagement with stakeholders, we have found the following features to be favourable for them and feasible for our project, helping our project position as a strong competitor in the market.
Specificity
From literature reviews, we know that the high specificity of microRNA in faecal samples for CRC and AA are well-documented, where even FIT has limited specificity in AA. More encouragingly, miRNAs are more specific than the FOBT rapid test kits in the market.
Convenience
Rapid results
The kit will provide a qualitative result of the presence of CRC by using coloured proteins, which would quickly dye the buffer to an easy-to-distinguish hue for patients to identify whether they are at risk of CRC.
Domestic use
Convenience is also a significant factor for people to screen for CRC regularly. Thus, we decided to design a kit that can be used conveniently at home, resembling rapid antigen tests (RAT) and the INDICAID home-use FOBT test kit. Not only that, a home-use test kit can also induce people to screen more on their own, alleviating the workload of healthcare workers.
Personalized medicine
Early detection
Greater morbidities result from later stages so we should detect CRC as soon as possible. Meanwhile, we have found that some of the microRNAs are upregulated in early CRC and even precancerous AA, so by detecting them, we can easily spot out people in need.
Lower-class asymptomatic patients as target users
CRC patients do not have reliable precursors, suggesting a large portion of the at-risk group is potentially suffering from CRC. Therefore, the target group of our test kit should be the asymptomatic groups, e.g., middle-aged individuals.
From our public surveys and interviews, we found that they need accuracy > convenience > price. In that cohort, we have to put a particular focus on the grassroots, who may have little access to the local CRC screening tools.
Clinical position
Our kit should serve as an assistant to FIT. FIT and colonoscopy are highly accurate and reliable. Thus, it is not practical to replace them. However, our kit should aim to replace the FOBT fast test kit, which has limited accuracy.
Integrated Human Practice of Our Project
Integrated Human Practice, as its name suggests, not only involves interviews and surveys, but also integration of our work by continuously incorporating the feedback from stakeholders into the wet lab and our education team, and vice versa, forming a feedback loop.
Public Sector
The public feedback loop demonstrates how community insights shape and validate our miRNA-based rapid CRC test kit. We first conducted an online survey (n=286), which revealed 77.1% avoid screening due to cost and awareness, with 81% interested at HK$100-300.
Responding to their needs, the education team launches CRC awareness events to address the 24% unaware, and we set out to craft a kit with the clinical position of “a highly specific home-use rapid CRC test” as the kit utilises miRNA-based mechanisms, which are specific in action, and with easy collection to boost screening.
Our responses were validated by Phase 3 street interviews assessing public uptake. From the result of the interview, we found out that accuracy of miRNAs, convenience and price, which are our clinical niches, are deemed the 3 most important factors for the public, confirming that our kit’s features align with stakeholders’ needs.
Healthcare Sector
The healthcare feedback loop illustrates how our design is refined with clinical practices and patient care. To begin with, Dr. Steven Siu, emphasized unreliable precursors like blood in faeces (often mistaken for haemorrhoids) and public reluctance towards CRC screening due to their cost and low awareness. He suggested the kit should assist FIT.
Also, Dr. Dennis Ngo stressed the need to target asymptomatic patients. It is worth noting that FIT has low sensitivity in AA, which could be the potential niche of our kit
Figure 15. (right) Interview with Dr Dennis Ngo
The interview with Dr. Alice Chan, who provided expertise on nursing techniques and challenges. With her deep understanding in CRC patients, we identified that the grassroots have limited access to local CRC resources and we should tailor our kit for them, and optimized the features they desired, such as convenience and rapidity, for our kit.
As for our feedback, the wet lab is optimizing miR-21 and miR-135b toehold switches for specificity, addressing doctors’ insights; concurrently, the education team is creating CRC awareness and embarrassment-reducing activities to support patients and nurses, aligning with student observations.
As a result, in Phase 3 (block in sharp orange), nursing students help validate our project’s alignment with healthcare requirements. For example, the home-use nature of the kit reduces workload.
Science Sector
The science feedback loop is mainly situated in Phase 2 for continuous co-design, illustrating how research expertise advances and validates our kit’s technical foundation. With our preliminary ideas – a miRNA-based test kit, formed from Phase 1, Dr William Wu agreed with the potential of miRNAs, a panel of which can give better accuracy, but also pointed out some possible challenges in the development of our kit, such as not enough miRNAs in CRC patients to give visible qualitative results and concerns about toehold rapidity.
After that, HKMU experts suggested the LacZ reporter gene as a EGFP alternative and raised faecal impurity concerns.
As an outcome, we did extensive literature reviews to choose 2 competent candidates for our test kit within our constraints. Also, the wet lab tests LacZ and discusses possible designs and pre-treatment protocols for miRNA stability and impurities to give clear results rapidly.
Industry Sector
The industry feedback loop stresses how we form our kit’s commercialization strategy with industries’ input. The Industry Input node includes: Dr. Ricky Chiu emphasized higher accuracy than FOBT using miRNAs, and expressed concerns about the indirectness of using the rarely used biomolecules.
To address their needs, not only do we spare no effort to test and research the miRNA panel to meet Dr. Ricky Chiu’s accuracy goal, but we also found out that toehold switches can be a wonderfully versatile synthetic biology tool for detecting miRNAs.
Furthermore, we explored a market strategy and regulatory roadmap in the interview with Dr. Francis Chan, an industrial leader and core research member of a novel CRC test called M3CRC. We discussed possible market implementation strategies as well as FDA/NMPA certification to ensure the reliability and accuracy of our test, setting the validation benchmarks.
Implementation of Our Human Practice
Overall records of our implemented human practices:
Table 2. Overall records of IHP work
Online Survey
Objective
To investigate how our kit would be helpful to the public
To show the clinical importance of the detection kit
To identify the needs of potential users
To understand the medical habits of the public
Methodology
Via Google Forms
Published through the public social media pages (e.g. Instagram)
Yielded a sample size of 286 interviewees
Summary
HK people have a limited understanding of CRC. Some individuals may not even recognize they have CRC, even with multiple symptoms of CRC. This shows the importance of the kit by providing the public with an accurate KIT to prevent overlooking this problem.
Results show that CRC screening programmes may not be well known in HK, with 69 respondents (around 24%) to not recognize any screening methods. This shows the lack of awareness of the public on CRC, which increases the risk of them getting CRC.
It is shown that the public has a positive view on a Rapid Test Kit for CRC, with 81% of respondents expressing their interest in purchasing a test kit. This shows that a kit can be useful and popular among the public.
The price of the Kit is preferred by most at HKD300 or lower.
Feedback on Our Project
Found out that HK people’s knowledge on CRC is insufficient, which leads to our education activities
Learnt about the requirements of a kit favourable to the public, such as reducing waiting time, convenience, easy-to-use and having a preferred price
Interview with Dr. Steven Siu
Objective
Dr Siu is a clinical oncologist at a local hospital
To better understand the goals of our rapid test kit concerning the needs of CRC patients
Summary
See more
Treatment and Management Differences Across CRC Stages
All CRC stages require surgery.
Late stages (III & IV) need extensive chemotherapy to reduce relapse, with metastasis often preventing full eradication.
Management focuses on surgical suitability (early stages) or chemotherapy tolerance (late stages).
CRC Precursors and Symptoms for Early Detection
Blood in faeces or egestion changes are unreliable due to overlap with haemorrhoids
Painful symptoms like abdominal pain appear in middle-late stages
Detection varies by tumour location.
Barriers to Frequent CRC Screening
Public reluctance to screening that stems from unwillingness, high costs, low awareness, and misconceptions about precursors
Those barriers deter them from having the ideal screening frequency of FIT every 2 years.
Impact of a Fast Test Kit on CRC Detection and Survival
A fast test kit can improve CRC detection and survival by:
offering lower cost,
higher sensitivity/specificity than FIT/FOBT
better awareness
It should FIT in Hong Kong’s screening framework, but not replacing colonoscopy.
Feedback on Our Project
Identified the need for early detection
Dr. Siu’s focus on early-stage survival from Question 1 validates the necessity of miRNA’s early-stage overexpression for the test kit.
Identified the need for more accurate biomarkers
Furthermore, acknowledging the unreliability of precursors, we noted the need for screening tools.
Explored clinical positions
The low screening uptake due to cost, unwillingness, and misconceptions emphasises the kit’s need for affordability and education. Additionally, given the high accuracy of current detection methods, the kit should assist FIT in Hong Kong’s screening framework, not replace colonoscopy, guiding commercialisation.
Interview with Dr. Dennis Ngo
Objective
Dr. Ngo is a surgeon who specialises in CRC surgery and works at a local hospital.
To enhance our understanding of CRC
To acknowledge our possible targeted group
Summary
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Target group for our test kit
We should target asymptomatic patients to maximise its functions and uses
CRC has no significant symptoms or precursors
Patients will not be adversely affected in the early stages of CRC
Early precursors of CRC
No significant precursors.
Only a few local presentations, including minor bleeding, obstructive symptoms, and inflammation of tumours etc.
CRC symptoms cannot be integrated into our kit due to their limited specificity and sensitivity.
Patients are advised to do a colonoscopy for accurate results, which is hardly replaceable by a rapid test kit or even a FIT test
Treatment ways for CRC
In early stages (I&II), simple surgery can be used to remove the tumour.
In late stages (III&IV), chemotherapy is needed to be used as metastasis occurs.
Downsides of the FIT test
Incapability in detecting AA
70 - 80% of CRC is developed from the adenoma carcinoma sequence
However, the FIT test has a low sensitivity (20 - 30%) in detecting AA
Feedback on Our Project
Support for the Early Detection of CRC from a Surgical Perspective
There is an apparent trend that intensity and complexity of treatment will increase according to the severity of different stages. We can draw that, the earlier CRC is being cured, the less the patient will suffer.
Identified critical weaknesses of FOBT/FIT that may be a niche for our kit
We have conducted a literature review on the regulation of miRNAs. It is suggested that our kit can target miRNAs that are upregulated in AA to make up for the deficiency of FIT. It helps to confirm our clinical position to target asymptomatic patients.
Interview with Dr. Alice Chan
Objective
Dr Chan is a Senior Lecturer at the School of Nursing at Tung Wah College
To learn about the needs of our first-line users, namely CRC patients and nurses, so that we can create a kit tailored to their needs.
Summary
See more
Challenges in nursing CRC patients
Nursing difficulty depends on the patients’ progress
Some device is permanently attached to the patient, affecting their dignity and self-image
Having a large device attached to the rectum can adversely impact their quality of life
Our kit is an appeal to the grassroots
Colonoscopy is excruciating with prohibitive costs, and probably needs someone to accompany
Our kit’s low cost, convenience and rapidity are appealing to people who are not in the screening demographic and do not have money → get more patients to go for CRC screening
We should target more on ethnic minorities, who may have little access to local CRC screening resources.
Suggestions on making our kit more convenient
To make the collection of samples not awkward for patients
Hospitals have holders that are put on the toilet that capture faeces into a bag, which could be integrated into our test kit
With clear and bilingual instructions
Feedback on Our Project
Lower-class at-risk groups as our target users
Dr Chan believes that the target group of our kit should be the lower social class, who need an affordable and accessible CRC test kit. One particular focus should be on the ethnic minorities, who do not know much about Hong Kong’s CRC screening tools.
Optimising the convenience and rapidity of our kit
The convenience and rapidity of our kit are crucial to get more people to screen for CRC. We can take the current stool collection procedure in local hospitals as a reference for our kit, as well as discover rapid biomarkers for our project.
Interview with Dr. Ricky Chiu
Objective
Dr. Ricky Chiu isan expert in biotechnology and the CEO and Founder of PHASE Scientific,
PHASE Scientific is a company that has invented numerous popular rapid test kits, including the Indicaid™ Faecal Occult Blood Test (FOBT) for detecting CRC.
To shape the design and positioning of our kit
To understand the differences between miRNA test and FOBT.
Summary
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Design and positioning of our miRNA detection kit
FOBT has a similar niche for early detection, known as the FOBT.
We inevitably need to compete with FOBT on two main aspects – accuracy and usability
Comparison with the current detection kit
Occult blood results in false positives more easily with piles or hurts.
miiRNA test kit has a higher specificity than FOBT by detecting upregulated miRNA in CRC
Potential Impacts of the miRNA Test Kit
People's awareness of CRC is not good enough.
Our test kit can we promote the harmfulness of CRC to the general public
Biosafety and bioethics
An individual diagnostic tool and an in-vitro test ours does not need to invoke any specific measures.
Feedback on Our Project
Finalised clinical position
Dr Chiu emphasised the need for rapidity, convenience, and accuracy, and our kit must have these qualities in order to have a place in the market. Thus, the kit is finally positioned to be a rapid home-use test kit for early screening.
Confirmed niches our miRNA kit can occupy compared to FOBT
As miRNA-based tests are unpreferred in the market, given their indirectness, it nudged us towards the use of toehold switches, which are versatile synthetic biology tools. Moreover, he figured that miRNA-based tests are more accurate than those of FOBT from a biotechnology perspective, which is likely to replace FOBT.
Identified the impacts of our test kit
Dr Chiu also believed our kit can help raise the public’s awareness of CRC, so our Education team continues to do so with different stakeholders.
Although we strictly conform to the regulations not to experiment with human samples, as an impact on the future, it might potentially involve human samples, such as faeces, which urges us to search for any biosafety and bioethical measures. With Dr Chiu’s insights, such concerns have been allayed, so we focus on the biosafety of our lab. For more details, please click here to visit our wet lab’s page.
Interview with Dr. William Wu
Objective
Dr William Wu is a Professor and Head of Graduate Division in Anaesthesia and Intensive Care, The Chinese University of Hong Kong.
To refine our project design with scientific basis and expertise
To delve into the use of miRNAs and possible directions of our test kit
Summary
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Potential and challenges using miRNAs
From his research, our target miRNAs, miR-92a and miR-135, are upregulated during CRC
Those miRNAs usually exfoliate into the intestinal lumen so it is appropriate to use faecal samples
Concerns on whether there is a significant increase in miRNA needed for our kit to produce sufficient coloured protein
Implementation of miRNAs into our project
miRNAs can produce a relatively fast result: miRNA detection can be done in a lab in 1 day, but it requires special equipment.
A panel of miRNAs over a single one could potentially increase the accuracy of the test, but may have associated implementation challenges with more targeted biomarkers
For other cancers, it is likely to detect them using miRNAs as they may also be upregulated in blood excreted from microvesicles and exosomes
Ensuring smooth and appropriate usage of the test kit
A dilute faecal sample can be obtained without interference, coloured protein can be used in a point of care and rapid test.
However, if the concentration of miRNAs is not high enough, we should opt for EGFP protein.
To ensure biosafety, we should carry out the test in a safety cabinet for lab-based tests
Ethically speaking, we need to acquire patients’ informed consent before they have the test
Feedback on Our Project
Testing out more 2 miRNAs
Due to technical and time constraints, we decided to only target miR-92a and miR-135b. In our stretch goals, we aim to try out more combinations of miRNAs to cover all specific biomarkers, and test out different protein expression options using the toehold switch.
Designing a rapid test kit
The wet lab proposed dissolving faecal samples in a solution, possibly EDTA buffers that retains RNA stability. Yet, more research is still needed to make a definite choice.
Developing a qualitative test
A significantly high concentration is crucial for our kit to become a qualitative test. Through literature reviews, we found that both target miRNAs have great fold increases in CRC that lead us to propose 2 modifications to our project design:
Setting up a toehold expression threshold gate with respect to miRNA concentration
Setting an appropriate read time
As for coloured protein to be observable, our team planned to carry out in vitro expression to determine whether our test kit works with diluted samples.
Interview with Healthcare Scientists
Objective
A group of health science experts from the School of Nursing and Health Sciences of the Hong Kong Metropolitan University (HKMU), including Dr. Cheung Ka Tik, Dr. Daniel Zhang, Dr. Stan Chan, Ms. Sandy Choi and Ms Janet Wong
To refine our project and receive suggestions for our wet lab development
To make a decision between the use of EGFP and coloured protein
Summary
See more
Acknowledge the limitations of EGFP and coloured proteins
Coloured proteins can reduce the use of the costly UV light.
Dr Chan came across a publication detailing a colourimetric method involving LacZ reporter gene as an alternative to EGFP in the toehold switch
Expressed concerns over whether faecal matter would interfere with the test
Stool samples are dirty with a lot of impurities, potentially interfering with the binding of the toehold switch with miRNAs
Pre-treatment or ways to reduce them are crucial, as suggested by Dr Zhang.
The form of faeces may also affect the test result
Feedback on Our Project
Refining the colourimetric methods
On top of our current proposed colourimetric methods, i.e. EGFP and coloured protein, we include the use of the LacZ reporter gene system as a choice for comparison and contrast with other avenues.
Possible Limitations associated with Faecal Impurities
To follow up on the experts’ concerns over faecal impurities, the wet lab carries out further investigation and research. Due to legal constraints, unfortunately, we do not have permission to perform any related testing on human samples. Nonetheless, the wet lab has discussed potential methods and DYOR (Do Your Own Research) on the collection of samples and in-depth testing, which will be included in our stretch goals and future plans.
Public Street Interview
Objective
To have a more precise and accurate understanding of CRC
To figure out the needs among the public for further actions
Methodology
A mix of multiple-choice questions, sort-by-priority question and scenario-type questions
Yielded a sample size of 59 interviewees
An even distribution of sex and age
Summary
84.7% of interviewees report they had none of CRC symptoms. It can be said that a large percentage of people are relatively healthy, or they do not focus on the symptoms of CRC.
Over 71.2% of interviewees reported that they had never conducted such screening, and 11.9% of the interviewees reported that they screen for CRC every 5 or more years. It can be concluded that most people do not have such a habit of doing screening for CRC, as we were told most CRC screenings are complicated and generally require large sums of money.
We found that accuracy is the most important factor the interviewees consider, then in order how easy to use, price and easy to get. This suggests that our main focus is on accuracy when we are making the kit.
The results resembled a U-quadratic distribution, suggesting polarity in habits for screening CRC.
The responses were polarized, with 40% of the interviewees deciding to go to hospital to do a screening, while 36% of interviewees will not have any followup actions. Still, a significant portion of the public directly go to hospital to check CRC when symptoms are observed, and thus, it is more meaningful for us to screen asymptomatic patients.
Feedback on Our Project
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Inadequate knowledge with public and subsequent education
From the street interview, it can be interpreted that the general public has inadequate knowledge in preventing and treating CRC. Understanding this status quo, our team has carried out extensive education to different institutions, teaching the general public and students the fundamental knowledge on CRC, consequently raising their awareness on such disease.
Aligned the test kit with the needs of the stakeholders
It allowed us to verify that the features of the kit aligns with the stakeholders’ needs as the public survey confirmed that people tend to not have a habit of checking for CRC. Also, it is reasonable to target asymptomatic patients as those with symptoms will be likely to go to the hospital directly. This ultimately completed the feedback loop second engagement with second engagement.
Interview with Dr. Francis Chan
Objective
Dr. Francis Chan is the former Dean of the Faculty of Medicine of the Chinese University of Hong Kong.
He is also an experienced gastroenterologist, he is a research member of the M3CRC detection test (click here for more info), which is a non-invasive, microbiome-based diagnostic test for CRC.
To obtain insight for Phase 3 Validation to brainstorm future actions from a successful novel CRC test
Summary
See more
Several qualities are crucial from the perspective of a patient
Accuracy, convenience, cost, and the implications of follow-up treatments are critical for consideration.
M3CRC test has identical advantages to FIT/FOBT, but is more sensitive and specific than them.
There are myriad difficulties in the process of designing a new kit
The process begins with asking critical questions about how the kit can contribute to both patients and society in tackling current deficiencies in diagnosis and prevention.
Asking why another occult blood test for CRC is needed when existing options are already available.
Designing research to establish a proof of concept: formulating a hypothesis that suggests measurable and recordable changes in biomarkers during the development of CRC.
Testing the hypothesis: a comprehensive approach, encompassing research, animal experiments, human tissue sample experiments, and clinical tests to establish accurate and reliable correlations.
Identifying the limitations of the test
Marketing the test kit: identifying the incentives that encourage individuals to use the kit, implementing strategies to enhance public acceptance, and persuading government bodies and pharmacies of its value
Achieving professional medical certification: FDA or NMPA
There is a need to promote the test kit among different stakeholders
Raising public awareness about the kit
Incentivising the public to adopt new habits for CRC detection
Persuading healthcare professionals of the kit's reliability and accuracy
Feedback on Our Project
Real-world Implementation Strategies
Dr Francis Chan’s insights on rolling out the M3CRC test can serve as a reference to our further investigation:
Identify limitations of the test
Test on lab animals
Test on in-vitro human tissue
Clinical test
Marketing + promotion
Although most steps are restricted by current guidelines, they can be included in our stretch goals and future plans.
Importance of education in promoting products to the market
Education is indispensable for our project. We should continue to introduce our project to different stakeholders (e.g., healthcare professionals), prompting to have a meeting with the nursing students from Tung Wah College.
Interview with Nursing Students from Tung Wah College
Objective
A total of 70 nursing students from Tung Wah College to gain inspiration for our project from their frontline experience.
As a response to the suggestion of Dr. Francis Chan to promote our project to other concerned professionals
To validate the qualities of our test kit from a nursing perspective for Phase 3
Summary
We learnt the nursing and diagnosis procedures of CRC patients, and noticed how our kit can help mitigate their workload.
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Comparison between nursing CRC patients and other patients
CRC patients may need more psychological and emotional support apart from physical care
The newly diagnosed CRC patients may wish to know the result faster.
Our kit addressing physical challenges in nursing CRC patients
The home-use test can reduce late-stage CRC patients with clear instructions
Our kit reduces their workload in managing medical devices such as stoma bags
Our kit countering patients’ avoidance reasons for screening
Patients have little time for tests.
The preparation procedures of CRC tests are too complex
Our simple home-based test kit can be an effective and simple method to save time
Feedback on Our Project
All the kit’s features align with the needs in the nursing context
As our kit is positioned as a home-use rapid test kit, it can address patients’ craving for a fast test result and save time, given that they are busy, while the home-use nature of the kit can reduce the workload of nurses.
Summary of Our Integrated Human Practice
IHP has collaborated with stakeholders in our local community, as well as other sub-teams (the Wet Lab and Education sub-teams), to help answer the questions that have arisen from our project development.
Achievements in Phase 1: Empathise and define
Why do we still need to make a new test kit when we have other CRC screening methods?
Colorectal cancer (CRC) is a significant public health issue in Hong Kong, but current screening methods like FIT have limitations, such as poor sensitivity for advanced adenoma (AA). Our project aims to create a more convenient, affordable, and accurate home-use test kit to improve early detection and public awareness..
What do our stakeholders need?
Through stakeholder analysis, we identified key needs:
Public: Affordable (HKD 100–300), easy-to-use, and rapid testing.
Healthcare workers: Early detection for asymptomatic patients, especially lower-class and ethnic minorities.
Medical professionals: More accurate biomarkers, with miRNAs showing promise for AA detection.
Achievements in Phase 2: Development and Co-design
Why miRNAs?
miRNAs like miR-135b and miR-92a-3p were selected for their high specificity and sensitivity in CRC and AA. Feedback from experts like Dr. Chiu and Dr. Wu validated their potential, leading us to focus on these biomarkers.
What’s with Toehold Switches?
Toehold switches offer a direct mechanism to detect miRNAs, addressing concerns about indirectness in traditional miRNA tests. Wet lab modifications, such as threshold gates and optimized read times, ensure reliable qualitative results.
How to ensure the test result is conspicuous and readable?
We explored colorimetric methods (EGFP, colored proteins, LacZ reporter gene) to ensure clear results. Feedback from HKMU experts guided our optimization for faecal sample interference.
Achievements in Phase 3: Validation and Implementation
Does our test kit actually matter?
Validation through street interviews and nursing student feedback confirmed the kit’s alignment with stakeholder needs: convenience, accuracy, and affordability. The home-use design reduces healthcare workload and encourages regular screening.
What’s next?
Future steps include strategizing product validation, clinical validation, and market promotion, inspired by Dr. Francis Chan’s M3CRC Test development. Education and stakeholder engagement remain critical for adoption.
To sum up, our miRNA-based toehold switch test kit has become a promising solution to bridge gaps in CRC screening, validated by extensive stakeholder collaboration.
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