Overview

Innovation Awards

The Center for Innovation and Translation of Point-of-Care Technologies for Expanded Cancer Care Access (CITEC) seeks to support and accelerate the development and adoption of affordable new technologies to improve the early detection of pre-cancer and cancer in community and home settings, including hard-to-reach and rural settings in the US. This solicitation prioritizes support for point-of-care tests to improve screening, early detection and/or diagnosis of pre-cancers and early cancers that arise in epithelial tissues in organ sites accessible for early detection, because this is where point-of-care technologies can have the most immediate impact. High-priority focus areas include: 

• Screening of cancers that are currently diagnosed radiologically (e.g., lung, breast) 
• Anal neoplasia screening 
• Histopathologic diagnosis of cancer and precancer at the point-of-care 

Applicants should consult CITEC’s Guide to Cancer Screening for more information about these opportunities. Priority will be given to platform technologies with potential for more than one organ site. 

Funds available

A total of $450,000 USD is available for 4-6 sub-awards to support improvements to point-of-care technologies for early cancer detection.  

Number of projects anticipated

CITEC may award $75,000 USD subawards with a performance period not to exceed six months or $150,000 USD subawards with a performance period not to exceed 12 months. 

Clinical Needs to Be Addressed

Most cancers can be cured if detected early and treated effectively. Yet, existing tests for early cancer detection are too complex and/or expensive to implement in home and primary care settings, particularly those that are hard to reach. The Center for Innovation and Translation of Point-of-Care Technologies for Expanded Cancer Care Access (CITEC) is working to identify high-priority clinical needs for point-of-care cancer technologies; to accelerate development of effective, affordable point-of-care technologies to meet these needs; to evaluate and improve the clinical impact of point-of-care technologies in varied settings; and to train developers and users to create and disseminate more affordable point-of-care technologies. CITEC prioritizes development of point-of-care tests to improve screening, detection, and diagnosis of pre-cancers and early cancers that arise in epithelial tissues accessible for early detection. 

Relevant links: https://www.nature.com/articles/s44222-023-00135-4  

Representative Clinical Scenarios to be Addressed

Breast Cancer: Breast cancer is the second most common cancer and the second most common cause of cancer death in the United States. Recent advances in early detection and treatment have contributed to improved survival rates; however, access remains limited in many settings, including the rural US. The USPSTF currently recommends biennial screening mammography for women aged 40-74; however, access to mammography is limited. Indeed, women in settings/areas with limited medical resources and/or infrastructure have lower survival rates <. To date, mammography is the only population-based strategy shown to reduce mortality but remains inaccessible to many women due to environmental and workforce limitations (infrastructure, technical support, diagnostic interpretation, etc.). 

Anal Cancer: The recently published ANCHOR (Anal Cancer/HSIL Outcomes Research) study showed that treatment of anal cancer precursor lesions reduces cancer risk for People Living with HIV (PLWH) ​(Palefsky et al., 2022)​, and clinical experts recommend screening with anal cytology and/or HPV testing ​(Albuquerque et al., 2019)​. Screen-positive patients are asked to return for a second visit to undergo high-resolution anoscopy (HRA) ​(Clarke & Wentzensen, 2018)​. Suspicious areas are biopsied and evaluated by a pathologist. HRA-guided biopsy requires a high degree of expertise; new HRA practitioners take around 200 cases to begin consistently identifying all precancerous lesions (high-grade squamous intraepithelial lesions (HSIL) or anal intraepithelial neoplasia grade 2 or more severe (AIN 2+) ​(Richel et al., 2014)​. Patients diagnosed with AIN 2+ return for a third visit to receive treatment. While treatment of anal precancer has been shown to reduce the risk of progression to cancer significantly, the multiple visit approach has led to high patient loss-to-follow-up rates ​(Fernandez, 2021)​. A study on the outcomes of an anal cancer-screening program from 2009 to 2019 found that only 58% of patients diagnosed with AIN 2+ returned for treatment ​(Silvera et al., 2021)​. Simplifying screening for HPV and early detection of AIN 2+ using point-of-care methods could improve anal cancer prevention. By offering an in vivo diagnosis during HRA, more selective biopsies could be performed. Additionally, the ability to delineate normal from neoplastic mucosa in real-time may facilitate “Screen & Treat” and “Screen, Triage & Treat” approaches, reducing the number of patients lost to follow-up. 

Diagnostic Pathology: Histopathology plays a crucial role in early detection and treatment of cancer and precancer. Microscopic examination of cells and tissues is currently the only way to diagnose cancer, and is needed to assess disease severity, help determine and manage treatment plans, and to monitor response to therapy. Despite widespread availability of microscopes, access to diagnostic pathology is limited in many settings, including community hospitals in the rural US, because of the high cost of equipment (e.g., microtomes and slide stainers) and the need for trained personnel (e.g., histotechnologists and expert pathologists) ​(Fleming et al., 2016)​ ​(Wilson et al., 2018)​. Given the shortage of expert pathologists (especially in remote and rural communities), these bottlenecks limit or delay clinical decision-making and eventually treatment, resulting in worse outcomes. Affordable point-of-care tools to support quality histopathologic diagnosis are needed. 

Scope of Projects

The proposed project must focus on a specific need related to screening or early detection of epithelial pre-cancer or early cancer in a community- or home-based setting and must show promise to improve health outcomes. The proposed project may consist of technology development activities including developing and/or refining technology, clinical field testing, establishing test characteristics, obtaining feedback on user steps from end users, evaluating usability, conducting market research on product concepts or prototypes with distributors, implementers, procurement agencies, policy makers or other stakeholders, evaluating test implementation, and assessing feasibility. The application should describe how an innovation award and/or targeted expertise from CITEC or other consultants will enable the technology to move forward in the development pathway. 

Relevant technologies that will be considered for innovation awards include, but are not limited to, point-of-care technologies that work with non-invasive or minimally invasive samples, point-of-care technologies for in vitro and in vivo imaging, paper-based point-of-care sensors, and/or mobile-based platforms. Qualified projects should be: based on a working prototype or an existing device to be adapted and demonstrate test characteristics compatible with the ReASSURED criteria ​(Land et al., 2019).  

Expected Technology Maturity

Applicants with a working prototype or an existing assay/device (not necessarily used for the proposed application) and preliminary data to demonstrate its potential for screening or early detection of epithelial cancer in community and/or home settings will have priority.  

Minimum preferred maturity levels in the product development cycle domains of GAITS (Guidance and Impact Tracking System, ​(Cimit, 2023)​ are:   

• Technology:  proof of concept (3) or preferably proof of feasibility (4);  
• Regulatory: proof of concept (3) or preferably proof of feasibility (4);  
• Marketing/Business: proof of concept (3) or preferably proof of feasibility (4);  
• Clinical: proof of concept (3) or preferably proof of feasibility (4). 

Applicant Eligibility

Applications from all sources, including domestic or foreign, public or private, and non-profit or for-profit, will be considered. Awards under this solicitation may be made only to NIH-eligible applicants. Details regarding specific requirements can be found in the NIH Grants Policy Statement Part II: Terms and Conditions of the NIH Grant Awards. Foreign parties (governments, universities, corporations, or individuals) will be screened against the various US government-restricted party lists as required by NIH guidelines. 

CITEC Resources Available to Awardees

CITEC makes adjunct resources available to awardees and other interested point-of-care technology researchers. These include:  

• NIH resources, such as the I-Corps program 
• Access to the Point of Care Technology Resource Network (POCTRN) 
• CITEC Technology Core Support: Access to a network of experts to support the design, fabrication, and rapid optimization of point-of-care imaging technologies, point-of-care molecular sensors, and machine learning based on image analysis strategies appropriate for mobile platforms. Engineering resources to support design, prototyping, technical evaluation, usability assessment, and design for manufacture for a wide variety of point-of-care diagnostic technologies, including point-of-care imaging tools, point-of-care molecular diagnostics, machine‐learning and artificial intelligence‐based algorithm development, and point-of-care mobile technology platforms. In addition, CITEC can provide navigator services to CITEC-funded investigators and develop a tailored package of support for commercialization activities and regulatory support. CITEC partnerships provide a unique mechanism to develop and disseminate technology for use in global markets. 
• CITEC Clinical Core Support: Access to a network of experts in clinical evaluation and translation of tools for cancer screening and early detection, including study design, IRB protocol development, and access to study sites in community settings. The clinical core can provide clinical input and feedback for technology development, optimization, validation, biostatistical expertise for study design and evaluation, pathology expertise for correlation and evaluation, and simulation center support for ex vivo or simulation models. 

Application Timeline Process and Criteria

Proposal Submissions

All proposals will be evaluated by at least three independent scientific reviewers who are external to CITEC. Only electronic submissions will be accepted. Submissions must be time-stamped by the submission system prior to or at the cut-off date and time listed in the timeline at the top right of this page. Please note that all deadlines are in Eastern Standard Time (EST). The Center will not consider proposals which are in the process of submission but not yet submitted prior to the cut-off and not stamped as received in time. Information that is relevant to your organization’s intellectual property should be marked “Business Sensitive” or “Proprietary.” Classified information or markings such as the word “Sensitive” alone must not be used in any part of the submission. 

Review Criteria

Significance:  

• Does the project address innovations to improve the screening, early detection or diagnosis of cancer, particularly for community and/or home settings?   
• Does the proposed technology have application for more than one cancer? 

Scientific Basis:  

• Is there a sound scientific basis presented (including preliminary data) that supports the technology and the proposed research? 

Responsiveness to CITEC/NIH Areas of Interest:  

• Is the project designed to accelerate the refinement and clinical testing of point of care technologies for early detection of cancer? Is the project designed to improve the screening, early detection or diagnosis of cancer? Will the technology under development accelerate rapid adoption into clinical practice? 

Technology Performance:   

• Reviewers will be asked to review the Technology Performance Criteria above. Is the project at a “late stage” of development (defined as ready for clinical validation or prototype refinement)? Projects proposing prototype development or preclinical studies are not in scope. Later-stage technologies that are closer to deployment will be given priority. 

Feasibility: 

• Does the scientific team have the transdisciplinary expertise to move the project forward (i.e., engineering, usability testing, clinician engagement, statistical expertise)?   
• Are all human subject regulatory procedures (e.g., approved IRB protocol) complete so that the project can start in a timely way?   
• Is it highly likely that the proposed science can be accomplished with the funding and time allotted? 

Expertise:  

• Do one or more members of the applicant team have expertise in affordable technology development and validation, and addressing gaps/needs in community and/or home settings? 

Implementation Science: 

• In the application, has the applicant team considered implementation science metrics and outcomes such as acceptability, adoption, appropriateness, fidelity, penetration, and sustainability? 

Population: 

• Does the proposed test have the potential to be applicable to varied settings? 

Innovation: 

• Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches, methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? 

Intellectual Property and Development Plan:  

• A path to implementation should be clearly outlined in the application. This includes regulatory, manufacturing, and distribution plans for the hardware and software used in the technology. Has a path to FDA or other appropriate regulatory approval been identified and is it clearly articulated? Is there a manufacturing and distribution strategy? 

Consumer Costs and Commercialization Strategy:  

• What is the commercialization strategy? Does the strategy have the potential to reach patients in remote communities? Does the strategy have the potential to reduce healthcare costs for patients and/or payors? 

Environment:  

• Do the study team and/or company have an environment that is conducive for success? Has there been outside investment in the company? 

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