POCTRN - NIH Participating Institute and Center Statements of Interest

    NIBIB National Institute of Biomedical Imaging and Bioengineering

    National Institute of Biomedical Imaging and Bioengineering

    The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB supports new tools and technologies to improve human health within its internal laboratories and through grants, collaborations, and training. In the area of POC technologies, the NIBIB supports research that enables patient-centered health care through the development and application of point-of-care and home-based technologies. The NIBIB will support point-of-care and home-based technologies to detect, measure, and analyze biological information including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters at the site of patient care or within the home to assist prevention, diagnosis, treatment, and management of diseases. NIBIB is interested in supporting Research Center(s) that are structured around emerging technologies, clinical needs and opportunities in the following example areas, but not limited to:

    • Primary Care
    • Emergency Preparedness
    • Emerging Infectious Diseases
    • Low-Resource Settings
    • Ambulatory Care

    The above suggestions are intended to be exemplary rather than exhaustive or prescriptive. See list of previously funded POCTRN TRDCs supported by NIBIB. 

    NHLBINational Heart, Lung and Blood Institute

    National Heart, Lung and Blood Institute

    The NHLBI supports development of technologies to detect, prevent, or treat heart, lung, blood and sleep (HLBS) disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources.

    The NHLBI is interested in sponsoring a Center to facilitate clinical validation and adoption studies for technologies that can be deployed in low-resource settings. The NHLBI Center will support clinical validation of POC technologies by serving as a “clinical laboratory” for innovators. To facilitate clinical validation of a technology, the NHLBI Center will provide appropriate clinical samples, test integration into clinical workflow and electronic health records, and optimize user interfaces. Additionally, the Center will support feasibility and demonstration studies to test how these technologies could be used in low-resource settings, and whether these technologies could improve the quality of life, quality of care, and reduce health care costs. The NHLBI Center will also conduct needs assessment to understand the critical unmet needs within these communities (including needs of healthcare providers and end users) and identify specific technologies, along with requirements for these technologies to be acceptable and usable in low resource communities. The NHLBI Center’s annual solicitation will require applicants to address implementation outcomes to close the “know-do” gap, such as accessibility, feasibility, costs, penetration and sustainability, because implementation science outcomes need to be considered at the beginning of the design and research of POC technologies for low-resource settings.

    The NHLBI POCTRN Research Center will not support early stage development of prototypes, but will support refinement of prototypes based on clinical validation results and user feedback. NHLBI supports early state prototype development work through the Catalyze Program. Functional prototypes that have been validated in animal models, when applicable, will be candidates for clinical validation studies within the Center. Services provided by the Center include, but are not limited to, the following aspects:

    • Provide clinical samples to validate analytic performance
    • Help to identify data management and integration issues and strategies
    • Provide access to clinical testing lab to identify issues and strategies in quality control, workflow integration, and unanticipated human factors
    • Provide feedback on user interface optimization and user acceptance
    • Provide initial data on device/technology usability in a real-world clinical setting
    • Provide statistical consultations

    Technologies that are already on the market but need additional demonstration studies for low resource settings will be candidates for additional clinical adoption support, which include but are not limited to the following examples:

    • POC technologies that aid in the home-based management of cardiometabolic disease by identifying acute decompensations (i.e., detection of an acute flare of chronic obstructive lung disease or decompensation after COVID-19 infection, thereby avoiding hospital admission) in specific populations (e.g., according to race, ethnicity, sex/gender, socioeconomic status).
    • OC technologies that help better define patients at risk of bleeding or thrombosis, including key groups such as those treated with anticoagulants for pulmonary hypertension, venous thromboembolism, pulmonary embolism, or atrial fibrillation.
    • POC technologies that help differentiate patients with atherosclerotic heart disease who will progress to myocardial infarction or sudden death from those with stable disease.
    • Technologies that can monitor or enhance physiological responses to therapies (e.g., continuous positive airway pressure devices) at the point of care for the treatment of sleep disorders.
    • POC devices that define physiologic, phenotypic, or molecular characteristics to predict HLBS outcomes and, when applied in clinical studies, predict differential responses to therapy in individuals and in different populations with HLBS disorders (e.g., sickle cell disease, heart failure).
    • “Smart” POC devices that both monitor physiology and use novel algorithms to assist, adjust, or intervene automatically to treat acute complications of cardiovascular disease (e.g., a heart failure monitor that can be used to adjust diuretic dosing to reduce acute heart failure worsening).
    • POC technology that enables real-time, individual-level remote monitoring that would be used to detect and predict worsening respiratory status and reduce risk for intubation or hospitalization (i.e., in the context of pneumonia or recovery from COVID-19).
    • POC technologies well-suited for use by healthcare providers in the ambulatory clinic or home setting that accurately measure critical determinants of health, including treatment adherence, integrate them into the electronic health record, and enhance quality of care.

    The NHLBI Center is anticipated to have the capacity to cover four main programmatic areas: heart, lung, blood, and sleep disorders. The applicant is encouraged to have co-investigators or collaborators with expertise in all four programmatic areas and should demonstrate the following in the application:

    1. Adequate clinical capacities to validate POC technologies, such as number of clinics, ability to conduct clinical research within the center, biospecimen banks, etc.
    2. Description of POC technologies that can be validated in the center at the onset of the award.
    3. Supporting letters from ongoing clinical trials or observational studies with the types of POC technologies that can be validated in the study.
    4. Plan for identifying and selecting POC technologies to be validated in the center.
    5. Have a strong partnership with under-served communities that have high burden of HLBS diseases.
    6. Capability to address social determinants of health (diverse and inclusive study populations) and strive for health equity.
    NCINational Cancer Institute

    National Cancer Institute

    The focus of the NCI in this initiative is to support the transition of scientific discoveries and engineering advances into tools to address clinical cancer research for assessment of cancer risk, cancer screening, early detection, prevention, diagnosis, treatment, treatment monitoring and/or disease management.

    The NCI is interested in funding one center for the development, validation and/or adoption of point of care technologies in clinical and other settings where the point-of-care device and assays will be deployed.

    The cancer POCTRN center is envisioned to incentivize the development of POC technologies for cancer care continuum, including technologies explicitly designed to address challenges and barriers associated with cancer health disparities and low resource settings. For this purpose, the center will encourage the engagement of minorities during technology optimization and validation to better serve underserved populations.

    Examples of POC technologies supported by the NCI include, but are not limited to:

    • POC technologies that work with non-invasive or minimally invasive samples
    • POCTs for in vitro and in vivo imaging
    • Portable platforms for near patient use
    • Paper based POC platforms
    • Printed sensor/electrode based POC platforms
    • Smartphone-based platforms (beyond cell phone apps)
    • Technologies that enable processing of complex samples, such as samples obtained by self-sampling, in the POC and point-of-need settings to quickly deliver results
       
    NIAIDNational Institute of Allergy and Infectious Diseases

    National Institute of Allergy and Infectious Diseases

    NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID advances the understanding, diagnosis, and treatment of many of the world’s most intractable and widespread diseases. 

    NIAID is interested in supporting, by intellectual and technical input and guidance, POCTRN TRDC that are structured around emerging technologies, clinical needs and opportunities focused on advancing innovative point-of-care and home-based diagnostic technologies for emerging and re-emerging infectious diseases, sexually transmitted infections, and other research areas within its mission. Technologies to distinguish vaccine induced seropositivity from infections or to allow early detection or characterization of emerging variants conferring resistance to treatment are needed.
     

    NIDANational Institute on Drug Abuse

    National Institute on Drug Abuse

    NIDA focus is to support the transition of scientific discoveries and engineering advances into tools to address the clinical and field research in the area of drug detection, screening and quantification with the goal of diagnosis, treatment, treatment monitoring and/or disease management. Additionally, devices aiding the determination of cause of death in cases of suspected drug overdose are of interest.

    NIDA is interested in funding one center for the development, validation and/or adoption of point of care (POC) technologies in clinical and other settings where the point-of-need devices and assays will be deployed.

    A NIDA POCTRN center is envisioned to incentivize the development of point of care (POC) technologies for substance use disorder (SUD) care continuum, including technologies explicitly designed to address challenges and barriers associated with SUD health disparities and low resource settings. For this purpose, the center will encourage the engagement of minorities, tribes, as well as justice system-involved groups during technology optimization and validation to better serve underserved populations.

    Examples of POC technologies supported by NIDA could include, but are not limited to:

    • POC technologies for drug quantification in blood, saliva, sweat or tissues with minimal or no sample preparation
    • POC technologies capable of analyzing 2 or more matrices without change in workflow
    • Reusable POC drug panels for rapid toxicology testing
    • Low-cost electrochemical, optical or calorimetric-based POC platforms for drug detection
    • POC technologies focused on rapid detection of emerging drugs of abuse and/or drug analogs
    • Technologies that enable processing of complex samples in point-of-need settings to facilitate the POC use of existing technologies
    NCCIHNational Center for Complementary and Integrative Health

    National Center for Complementary and Integrative Health

    The NCCIH supports the development and validation of technologies that assess symptoms commonly treated by the public with complementary and integrative health (CIH) approaches or technologies that monitor or enhance these approaches for symptom management, prevention of diseases, and promotion of well-being.  The CIH approaches of interest include natural products, such as herbs, prebiotic, probiotics, and selective medical diets, and mind and body practices including acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies. 

    NCCIH is particularly interested in the development and validation of technologies that aim to monitor, assess, enhance, or incorporate these CIH approaches into point of care for the following applications:

    • Pain and pain management;
    • Sleep and sleep disturbances;
    • Symptomatic conditions, such as those associated with menopause;
    • Management of mental health conditions commonly managed in primary care such as mild to moderate depression, or anxiety;
    • Behavior change to promote healthy behaviors such as healthy eating and physical exercise.

    The NCCIH is interested in supporting a Center(s) to facilitate the development, clinical validation, and adoption studies for clinic or other health settings where the point of care assessment or treatment will be deployed.  For this FOA, NCCIH will not support clinical trials. NCCIH does not need the Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to be in place at the time of application, but an IDE (if needed) must be obtained before an award is made.

    Examples of such technologies include, but are not limited to:

    • Mobile devices or applications that can monitor the dose, intensity, duration and/or frequency of CIH approaches employed by the patients at POC;
    • Technologies that can objectively measure pain or functional limitations due to pain, which would be treated by CIH approaches, at home or in primary care facilities;
    • Technologies that can monitor or enhance physiological responses to CIH approaches at POC for the treatment of pain, sleep disorder, mild to moderate depression, anxiety, or other symptomatic conditions;
    • Technologies that can objectively assess or monitor stress, pain, sleep dysfunction, depression, or anxiety, which would be treated or managed by CIH approaches, at home or in primary care facilities.
    FICFogarty International Center

    Fogarty International Center

    The FIC is interested in facilitating research in a Center on the development, validation, and adoption of technologies to address global health problems. Technologies studied should be specifically suited for low resource settings and applicable to low- and middle-income countries (LMICs; as defined by the World Bank as low-, lower-middle-, or upper-middle-income economies). Specific health areas of focus should be justified and highly relevant to priorities in LMICs. Additionally, the FIC is dedicated to building partnerships between U.S. and LMIC investigators and prioritizes collaborations with and training of LMIC researchers.

    Potential applicants interested in proposing projects related to HIV/AIDS should ensure that the research aligns with NIH HIV/AIDS high priority research topics by reviewing the NIH HIV/AIDS Research Priorities and the NIH Office of AIDS Research Strategic Plan
     

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