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 point-of-care (POC) technologies to improve the early detection of pre-cancer and cancer in hospital, mobile, community and home settings, including hard-to-reach and rural settings in the US. This solicitation prioritizes support for POC 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 POC technologies can have the most immediate impact. High priority focus areas include organ sites such as the lung, liver, and ovary, characterized by the following: 

• Screening of cancers that are currently diagnosed radiologically
• Cancers that currently lack affordable point of care diagnostic tools, are challenging to detect at an early stage, have high morbidity/mortality and are typically only screened for in high-risk populations 

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

Lung Cancer: Lung cancer is the leading cause of cancer-related mortality in the US and one of the most diagnosed cancers among both men and women. Despite evidence that early detection reduces mortality, most lung cancers are diagnosed at advanced stages. The U.S. Preventive Services Task Force (USPSTF) recommends annual low-dose computed tomography (LDCT) screening for adults aged 50–80 years with a significant smoking history; however, national screening uptake remains low, with fewer than one in five eligible individuals receiving recommended screening. Barriers include limited access to LDCT facilities, geographic disparities in imaging and specialty care, lack of awareness among patients and providers, and challenges in coordinating follow-up after abnormal results. Additionally, LDCT screening has a high false-positive rate, often triggering multi-step diagnostic pathways involving repeat imaging, invasive procedures, and specialist referrals, which can lead to delays, increased costs, and loss to follow-up. Disparities in lung cancer incidence and mortality persist by race, socioeconomic status, and geography. Point-of-care innovations that support early risk stratification, triage of screen-positive individuals, or minimally invasive diagnostic testing, especially tools deployable in primary care or community-based settings, could reduce diagnostic delays, improve follow-up, and expand the reach and effectiveness of lung cancer screening and early detection in the US.

Liver Cancer: Liver cancer incidence and mortality have risen steadily in the US over recent decades, with hepatocellular carcinoma (HCC) accounting for the majority of cases. HCC disproportionately affects individuals with chronic liver disease, including those with hepatitis B or C infection, alcohol-associated liver disease, and metabolic dysfunction-associated steatotic liver disease. Clinical guidelines recommend routine surveillance for HCC in high-risk populations, typically using abdominal ultrasound with or without serum alpha-fetoprotein (AFP) testing every six months. However, adherence to surveillance recommendations is suboptimal, and the effectiveness of ultrasound is limited by operator dependence and reduced sensitivity in patients with obesity or advanced liver disease. Access to imaging, hepatology specialists, and longitudinal surveillance is particularly constrained in rural and safety-net healthcare settings, leading to missed or delayed diagnoses. As a result, many patients in the US are diagnosed with advanced-stage disease and are no longer eligible for curative therapies. Point-of-care technologies that enable affordable, reliable, and minimally invasive surveillance or early detection of liver cancer, without reliance on advanced imaging infrastructure, could improve adherence to surveillance guidelines, facilitate earlier diagnosis, and reduce disparities in liver cancer outcomes across diverse US populations.

Ovarian Cancer: Ovarian cancer remains a leading cause of gynecologic cancer death in the US, largely because most cases are diagnosed at advanced stages. Early-stage disease is often asymptomatic or presents with vague, nonspecific symptoms, and there is currently no effective population-based screening strategy shown to reduce ovarian cancer mortality in average-risk women. Existing diagnostic approaches rely on a combination of pelvic imaging, serum biomarkers such as CA-125, and surgical evaluation, typically after symptoms prompt clinical concern. These pathways are poorly suited for early detection and are dependent on access to specialty care, including gynecologic oncologists, who are unevenly distributed across the US. Delays in recognition, referral, and diagnosis are common and contribute to poor survival outcomes and persistent disparities by geography and socioeconomic status. Point-of-care innovations that support earlier identification of high-risk individuals, triage of symptomatic patients, or real-time assessment of malignancy using affordable, minimally invasive tools could transform ovarian cancer care. Such technologies have the potential to improve diagnostic timeliness, optimize referral pathways, and ultimately reduce ovarian cancer mortality in the US.

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. 

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

A subset of responsive full proposals will be evaluated by 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 Table 1: Key Dates for Application and Anticipated Award Deadlines. Please note that all deadlines are in Eastern Time (ET). CITEC will not consider proposals that are in the process of submission but not yet submitted prior to the cut-off and not stamped as received in time. Information 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 at the point-of-care? 
• 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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