Prostate cancer molecular rapid diagnostic test

Prostate cancer is a silent disease, often detected at a critical stage, and is the leading cause of death among men aged 40 and above in Nigeria,  (https://www.ijaar.org/articles/v8n10/ijaar81015.pdf) with 10.8% of male population at risk of developing the disease before the age of 75 (https://gco.iarc.fr/today/data/factsheets/populations/566-nigeria-fact-sheets.pdf). Early diagnosis is challenging due to the lack of cancer-specific markers, limitations of the PSA test (https://www.mdpi.com/2073-4425/11/12/1396), genetic diversity signatures of the black African population(https://www.frontiersin.org/articles/10.3389/fonc.2020.606400). To improve disease management, a simplified Lamp-CRISPR/Cas-based test holds great promise. (https://doi-org.ezproxyberklee.flo.org/10.1021/acs.analchem.1c02533)

Early detection is crucial for improving patient outcomes, increasing the chances of successful treatment and reducing the burden. By utilizing the CRISPR-Cas12a and Lamp technologies, this project will provide a faster and more cost-effective diagnostic method compared to traditional techniques, like PCR and sequencing techniques. The point-of-care nature of the test enables it to be easily implemented in resource-limited settings, such as Ogun state in Nigeria, where access to advanced laboratory facilities may be limited. Additionally, focusing on the specific genetic and genomic signatures of the black African population, the project will address the unique characteristics and challenges of prostate cancer in this population. We plan to develop a CRISPR-Cas12a/LAMP point-of-care test for early prostate cancer diagnosis in Ogun state, Nigeria. We will gather genomic data from established cancer genomics databases and use advanced bioinformatics techniques to identify dysregulated genes and molecular signatures associated with prostate cancer. Experimentally, we will recruit 50 participants and collect urine, blood and biopsies for further exploration. Using Lamp-CRISPR-Cas12a technology and qPCR, we will assess the presence and expression levels of two identified genes and signatures. 

The solution of developing a non-invasive and cost-effective CRISPR-Cas12a/Lamp point-of-care test for early diagnosis of prostate cancer in Ogun state, Nigeria aims to serve the target population of men at risk of or affected by prostate cancer. This includes individuals in Ogun state and potentially other regions in Nigeria where access to advanced diagnostic tools is limited.

To understand the needs of the target population, extensive research will be conducted to gather data on the prevalence of prostate cancer, existing diagnostic methods, and the challenges faced by healthcare providers and patients. This research will involve engaging with healthcare professionals, patients, and relevant stakeholders through surveys, interviews, and focus group discussions.

By developing a non-invasive and cost-effective diagnostic test, the solution addresses the needs of the target population in several ways. Firstly, it eliminates the need for invasive procedures, such as biopsies, which can be uncomfortable and costly. This improves the overall patient experience and reduces the financial burden on individuals seeking early detection. Secondly, the point-of-care nature of the test enables faster results, allowing for timely intervention and treatment planning. This will significantly contribute to improving patient outcomes and survival rates.

Engaging the target population throughout the development process ensures that the solution aligns with their specific needs and challenges. Continuous feedback and collaboration with healthcare professionals and patients will shape the design, implementation, and dissemination of the test, ultimately leading to a solution that directly and meaningfully improves the lives of those affected by prostate cancer in Ogun state, Nigeria.

Our team is well-positioned to deliver this solution for several reasons. Firstly, as the Team Lead, I have a deep understanding and personal connection to the communities we aim to serve. I have spent significant time in Ogun state, Nigeria, and have witnessed firsthand the challenges faced by individuals affected by prostate cancer. This proximity to the community allows me to empathize with their needs and perspectives.

Furthermore, our team consists of diverse members who bring different backgrounds and expertise to the table. We have researchers with a strong scientific background in biotechnology and molecular biology, clinicians with experience in diagnosing and treating prostate cancer, and community engagement specialists who understand the importance of involving the target population in the solution development process.

To understand the needs of the communities we serve, we actively engage with them through various means. We conduct regular meetings and discussions with healthcare professionals, patient support groups, and advocacy organizations to gather insights and feedback. We also conduct surveys and interviews with patients to better understand their experiences, challenges, and preferences regarding diagnostic methods. This ongoing engagement ensures that the design and implementation of our solution are guided by the input, ideas, and agendas of the communities we serve.

Meaningful community participation is at the core of our approach. We involve community members in decision-making processes, prioritize their perspectives, and co-create solutions with them. This collaborative approach ensures that our solution addresses their specific needs, is culturally sensitive, and has a higher chance of acceptance and adoption within the target population.

Driven by the discovery of trans-cleavage activity by several Cas nucleases, highly sensitive, specific and rapid CRISPR-Cas based assays have been developed in the last few years for infectious disease diagnostics at POC.  Previous work performed by researchers from the University of Cambridge in MBOALAB Biotech In Yaoundé Cameroon, optimized CRISPR-Cas12a assay protocol for typhoid fever diagnostics in Cameroon, which included the assay’s affordability and robustness. Therefore, the overall aim of the project was to make the CRISPR-Cas12a assay more affordable and robust. so in collaboration with Mboalab Biotech in Cameroon and the team in University of Cambridge we intend to continue the project but adapt the protocol in cancer diagnosis the case of prostate cancer. 

I am applying to the Prize because I believe it provides a unique opportunity to accelerate the development and implementation of our solution for early diagnosis of prostate cancer in Ogun state, Nigeria. The specific barriers we hope the Prize can help us overcome include financial and technical challenges.

Financially, the Prize can provide the necessary funding to support our research activities, prototype development, and field testing. It can help us secure resources and equipment required for the CRISPR-Cas12a/Lamp point-of-care test, which may otherwise be limited due to budget constraints. Additionally, the Prize can support the dissemination of our solution by covering costs associated with awareness campaigns, training programs, and community engagement initiatives.

Technically, the Prize can provide access to expert mentorship, technical support, and specialized training in areas such as molecular diagnostics, point-of-care testing, and product development. This guidance and expertise can help us optimize and refine our solution, ensuring its accuracy, sensitivity, and reliability. Moreover, the Prize can connect us with a network of professionals and stakeholders who can provide valuable insights and partnerships to further advance our project.

By overcoming these barriers, the Prize can enable us to accelerate the development and implementation of our solution, ultimately improving the early diagnosis of prostate cancer in Ogun state. The financial and technical support provided by the Prize will empower us to overcome challenges that may otherwise hinder the progress of our project, making a significant impact on the lives of individuals affected by prostate cancer in our community.

As team Lead I have a strong connection to the community in which our project is based. As a resident of Ogun state, Nigeria, I understand the local context, cultural dynamics, and healthcare challenges faced by the community. I have actively engaged with community members, healthcare professionals, and stakeholders to gain firsthand insights into the needs and concerns related to prostate cancer diagnosis.

I established partnerships with local healthcare facilities, research institutions, and community organizations to foster collaboration and gather input from diverse perspectives. By actively participating in community outreach programs, health campaigns, and awareness initiatives, I built trust and rapport with community members, ensuring their voices are heard and their needs are taken into account during the development of our solution.

Through this direct connection to the community, I have been able to understand the unique challenges and barriers that individuals face regarding early diagnosis of prostate cancer. By incorporating community input and feedback into the design and implementation of our solution, we aim to ensure that it is tailored to the specific needs, preferences, and cultural contexts of the community we serve.

Our solution is innovative and sustainable in several ways. First, we are leveraging the power of CRISPR-Cas12a/Lamp technology, which allows for highly specific and sensitive detection of genetic markers associated with prostate cancer. This approach offers a significant improvement over traditional diagnostic methods, providing faster and more accurate results with minimal invasiveness.

Furthermore, our point-of-care-based test is designed to be cost-effective and easily deployable, making it accessible to resource-limited settings such as Ogun state, Nigeria. By eliminating the need for complex laboratory infrastructure and specialized personnel, our solution addresses the existing barriers to early diagnosis, particularly in underserved communities.

In addition, our solution has the potential to catalyze broader positive impacts in the field of cancer diagnostics. By demonstrating the effectiveness and feasibility of non-invasive and cost-effective point-of-care testing, we hope to inspire other researchers and innovators to explore similar approaches. This could lead to a shift in the market towards more affordable and accessible diagnostic tools, ultimately benefiting communities beyond our immediate target population.

Overall, our innovative and sustainable solution has the potential to change the market by revolutionizing the early diagnosis of prostate cancer. By combining advanced molecular technology with affordability and accessibility, we aim to improve healthcare outcomes, reduce the burden on healthcare systems, and empower individuals to take proactive steps towards their health.

Our impact goals for the next year and the next five years are centered around creating a transformational impact in the early diagnosis of prostate cancer and improving the lives of individuals in Ogun state, Nigeria, and beyond. Our specific impact goals are as follows:

Next Year:

• Develop and validate a prototype of the CRISPR-Cas12a/Lamp point-of-care test for early diagnosis of prostate cancer.
• Conduct extensive clinical trials to evaluate the performance and accuracy of the test in diverse patient populations.
• Establish partnerships with local healthcare providers and organizations to pilot the implementation of the test in Ogun state.

Next Five Years:

• Scale up the production and distribution of the point-of-care test to reach a broader population, including rural and underserved areas in Nigeria.
• Collaborate with national and international stakeholders to advocate for the integration of our test into healthcare systems and guidelines for prostate cancer diagnosis.
• Train and empower local healthcare professionals in the implementation and utilization of the test to ensure sustainability and long-term impact.
• Continuously monitor and evaluate the impact of the test on early detection rates, treatment outcomes, and overall survival rates in prostate cancer patients.

In measuring our progress toward our impact goals, we will utilize a combination of indicators that align with the UN Sustainable Development Goals (SDGs) and are specific to our solution's objectives. Some key indicators we will use to measure our progress include:

• Early detection rates: We will track the percentage increase in the number of prostate cancer cases detected at an early stage using our CRISPR-Cas12a/Lamp point-of-care test compared to conventional diagnostic methods.
• Treatment outcomes: We will assess the improvement in treatment outcomes, such as the percentage of patients who receive timely and appropriate treatment following early diagnosis, as well as the increase in overall survival rates.
• Test accessibility: We will monitor the distribution and accessibility of the point-of-care test by measuring the number of healthcare facilities, particularly in rural and underserved areas, where the test is available and utilized.
• Stakeholder engagement: We will evaluate the level of engagement and collaboration with key stakeholders, including healthcare professionals, local communities, government agencies, and advocacy organizations, to ensure the successful adoption and integration of the test into existing healthcare systems.
• Awareness and education: We will measure the impact of our community engagement and education initiatives by assessing the increase in knowledge and awareness of prostate cancer, early detection, and the availability of the CRISPR-Cas12a/Lamp test among the target population.
• Policy influence: We will track the extent to which our advocacy efforts result in policy changes or recommendations for the integration of the test into national or regional guidelines for prostate cancer screening and diagnosis.

By regularly monitoring and evaluating these indicators, we will be able to assess our progress, identify areas for improvement, and make data-driven decisions to ensure the effectiveness and sustainability of our solution.

Our solution, the development of a non-invasive and cost-effective CRISPR-Cas12a/Lamp point-of-care test, is designed to have a significant impact on the early diagnosis of prostate cancer in Ogun state, Nigeria.

Here's a simple explanation of how and why we expect our solution to make a difference:

• Activities: We will conduct research and development to design and optimize a CRISPR-Cas12a/Lamp-based test for the early detection of prostate cancer. This test will be non-invasive, cost-effective, and suitable for point-of-care settings, making it accessible to underserved communities.
• Outputs: The outputs of our activities will include a validated and optimized CRISPR-Cas12a/Lamp assay specifically designed for early detection of prostate cancer. We will also develop standard operating procedures, training materials, and guidelines for the implementation of the test.
• Immediate outcomes: By developing this innovative diagnostic tool, we aim to improve early detection rates of prostate cancer in Ogun state. Early detection allows for timely intervention and treatment, increasing the chances of successful outcomes and reducing the burden on healthcare resources.
• Longer-term outcomes: The successful implementation of our solution can have broader positive impacts. It can lead to reduced morbidity and mortality rates associated with prostate cancer by enabling early intervention. It can also improve the overall healthcare system by reducing late-stage diagnoses, providing more targeted treatments, and increasing survival rates. Additionally, our solution can serve as a model for similar initiatives in other regions, catalyzing advancements in cancer diagnostics and improving healthcare practices.

To assess the impact of our solution, we will measure indicators such as the number of early-stage prostate cancer cases detected, the percentage of patients receiving timely treatment, and the overall survival rates. We will also gather feedback from healthcare professionals and patients to evaluate the acceptability and effectiveness of the CRISPR-Cas12a/Lamp test in real-world settings.

By providing a non-invasive and cost-effective diagnostic tool for early prostate cancer detection, we expect our solution to improve patient outcomes, reduce the burden on healthcare resources, and contribute to better healthcare practices in Ogun state and potentially beyond.

The core technology that powers our solution, the development of a non-invasive and cost-effective CRISPR-Cas12a/Lamp point-of-care test for early diagnosis of prostate cancer, is based on the combination of two powerful molecular biology techniques: CRISPR-Cas12a and Loop-Mediated Isothermal Amplification (Lamp).

CRISPR-Cas12a is a revolutionary gene-editing technology that allows precise targeting and modification of specific DNA sequences. In our solution, we harness the highly specific binding ability of CRISPR-Cas12a to detect and amplify specific DNA markers associated with prostate cancer.

Lamp, on the other hand, is an isothermal amplification technique that enables rapid and efficient DNA amplification at a constant temperature. This eliminates the need for complex thermal cycling equipment, making it suitable for point-of-care settings with limited resources.

By combining the specific DNA recognition capabilities of CRISPR-Cas12a with the rapid amplification power of Lamp, we can detect and amplify prostate cancer-related DNA markers in a simplified and cost-effective manner. The result is a user-friendly, non-invasive, and portable diagnostic tool that can be easily deployed in clinics, community health centers, and other healthcare facilities.

The core technology of our solution leverages the advancements in molecular biology and gene-editing techniques to provide a highly accurate and sensitive method for early diagnosis of prostate cancer. By integrating these technologies, we aim to improve the accessibility, affordability, and effectiveness of prostate cancer screening, ultimately leading to better patient outcomes and a reduction in the burden of the disease.

In addition to the core technologies of CRISPR-Cas12a and Lamp, our solution also incorporates bioinformatic analysis for gene marker identification specific to the African population.

Bioinformatic analysis plays a crucial role in identifying and analyzing genetic variations and markers associated with diseases, including prostate cancer. By utilizing genomic data from diverse African populations, we can identify specific gene markers that are relevant to prostate cancer in this population. This analysis involves processing and interpreting large-scale genomic datasets, applying statistical algorithms and computational models to identify significant genetic variations and associations.

The integration of bioinformatic analysis allows us to tailor our diagnostic test specifically for the African population, considering the unique genetic characteristics and diversity within this population. By identifying and targeting gene markers that are more prevalent or specific to African individuals, our solution aims to improve the accuracy and reliability of prostate cancer diagnosis in this context.

By combining the power of CRISPR-Cas12a and Lamp technologies with bioinformatic analysis, we can develop a comprehensive and innovative solution for early diagnosis of prostate cancer in the African population. This integration allows us to address the specific genetic variations and markers relevant to this population, enhancing the precision and effectiveness of our diagnostic test and ultimately improving the outcomes for individuals at risk of prostate cancer.

Through a previous research CRISPR Dx Academy project undertook in Mboalab Biotech in Cameroon and the application in Typhoid diagnosis in Cameroon and scientific research and validation studies demonstrated by Gong et al., 2021 https://pubs.acs.org/doi/10.10... , additionally Chen et al.,2023 who demonstrated the application of the technology in the diagnosis of prostate cancer in his work via this link  https://www-sciencedirect-com.ezproxyberklee.flo.org/...

prof OGUNLANA ADEBANKE Olujoke the Lecturer of Biochemistry in Covenant University in Nigeria Project Manager of the project

NGUEDIA KAZE Niels the project Investigator Training Manger MBOALAb Biotech in Cameroon and Research Assistant Covenant University in Nigeria 

Melingui Bernard the Biostatiscian of the projet 

Stephane FADANKA Executive director Mboalab Biotech and Expert of the applied technology in the project responsible for technical assistant 

DJIYOU Armando Biotechnologist and Technical Assistant in the project 

we started the project since 2022

in the team each one has a specific tasks and each end of a month there is monitoring meeting where everybody present the indicators of success, challenges and solution to transcend the issues. 

1. Value proposition: Provide a non-invasive and cost-effective point-of-care test for early diagnosis of prostate cancer in Ogun State, Nigeria, using CRISPR-Cas12a/Lamp technology. The solution aims to improve the accessibility and accuracy of prostate cancer diagnosis, leading to early intervention and better patient outcomes.

2. Customer segments:

   • Healthcare institutions: Hospitals, clinics, and diagnostic centers that can offer the test to their patients.
   • Medical professionals: Oncologists, urologists, and healthcare providers who can utilize the test for accurate diagnosis and treatment planning.
   • Patients: Individuals who can benefit from early detection of prostate cancer for timely medical intervention.

3. Channels:

   • Collaborations with healthcare institutions: Establish partnerships with hospitals and clinics to offer the test through their existing infrastructure.
   • Direct outreach to medical professionals: Conduct workshops, training sessions, and awareness campaigns to educate healthcare professionals about the benefits and usage of the test.
   • Patient awareness programs: Engage in community outreach, health fairs, and online campaigns to raise awareness among the target population about the importance of early detection and the availability of the test.

4. Revenue streams:

   • Test kits: Generate revenue by selling the CRISPR-Cas12a/Lamp test kits to healthcare institutions at a competitive price.
   • Service fees: Charge a fee for conducting the tests and providing diagnostic reports for patients.
   • Licensing and partnerships: Explore opportunities for licensing the technology or forming strategic partnerships with relevant stakeholders.

5. Key resources and activities:

   • Research and development: Continuously invest in R&D to improve the test's sensitivity, specificity, and cost-effectiveness.
   • Laboratory facilities: Establish a well-equipped laboratory for sample analysis and test validation.
   • Regulatory compliance: Ensure compliance with relevant regulations and obtain necessary approvals for diagnostic use.
   • Training and support: Provide training and technical support to healthcare professionals using the test.

6. Cost structure:

   • Research and development expenses: Allocate resources for ongoing research, validation studies, and technology optimization.
   • Laboratory infrastructure: Invest in necessary equipment, reagents, and consumables for efficient sample analysis.
   • Marketing and outreach: Allocate a budget for marketing activities, including workshops, awareness campaigns, and online presence.
   • Operational costs: Cover overhead expenses, staffing, quality control, and regulatory compliance.

1. Grants and donations: Seek funding from governmental and non-governmental organizations, philanthropic foundations, and research institutions that support initiatives in healthcare, cancer research, and innovative diagnostics. Apply for grants, research funding, and competitive awards to secure financial support for project implementation and ongoing operations.

2. Product and service sales: Generate revenue by selling the CRISPR-Cas12a/Lamp test kits and associated products to healthcare institutions and professionals. Develop a scalable and cost-effective manufacturing process to ensure competitive pricing while maintaining product quality and performance.

3. Service contracts and partnerships: Collaborate with healthcare institutions, diagnostic centers, and government agencies to establish service contracts for conducting tests and providing diagnostic reports. Explore partnerships with organizations involved in cancer screening and treatment programs to offer the test as part of their service packages.

4. Licensing and intellectual property: Protect any intellectual property associated with the CRISPR-Cas12a/Lamp technology through patents or other appropriate means. Explore licensing opportunities to generate revenue through technology transfer or partnerships with other diagnostic companies or research institutions.

5. Health insurance coverage: Work towards securing coverage for the CRISPR-Cas12a/Lamp test by engaging with health insurance providers and demonstrating its clinical and cost-effectiveness. This will enable patients to access the test without significant financial burden.

6. Collaboration with research institutions: Collaborate with academic and research institutions to secure research grants and conduct collaborative studies to further validate and refine the CRISPR-Cas12a/Lamp technology. Such partnerships can also attract additional funding and enhance the project's credibility.

7. Fundraising and awareness campaigns: Organize fundraising events, crowdfunding campaigns, and public awareness initiatives to engage the community and garner support for the project. Collaborate with local and international organizations to amplify the impact and reach of these campaigns.

1. the project CRISPR CAs 12 LAMP for the diagnosis of typhoid funded University of Cambridge EPSRC Institutional Sponsorship 2021/22 - International Partnerships (Funder ref:             EP/W524293/1) that financed the project for about 25000£