Description:
Introduction
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), works to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes. NCATS focuses on research that impacts systemic change across the entire translational spectrum from basic research, pre-clinical research, clinical research, clinical implementation, and public health. NCATS encourages innovative approaches to systemic change and is disease and science domain agnostic. NCATS is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster, and strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to all patients.
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications from Small Business Concerns (SBCs) to pursue the development of improved clinical diagnostics or the development of alternative clinical diagnostics that address health inequities created by clinical laboratory assays and/or point-of-care devices that fail to incorporate diverse patient groups. Applicants will identify a potential issue within a clinical diagnostic or group of clinical diagnostics that perpetuates health inequity and disparities, clearly define the disparity issue, and develop a solution to address the concern. In using this funding, it is expected that recipients will lay the groundwork for implementation of more equitable clinical diagnostics that lead to improved health, healthcare delivery, and the elimination of health disparities.
Key Definitions
Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as “health disparity populations” based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Black Americans and African Americans, Hispanics and Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, individuals or groups with disabilities, and sexual and gender minorities.
Clinical Diagnostic: clinical tools, assays, devices or other resources for the purpose of identifying, characterizing, defining or diagnosing a disease state to identify, treat or prevent disease, as well as the screening, prognosis, therapeutic monitoring and/or evaluation of the progression of any disease.
Non-biological Parameter: parameters utilized in a clinical diagnostic that do not have a biological context, such as race and/or ethnicity, cultural differences between groups or population distribution, among others.
Social Determinants of Health (SDOH): SDOH are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.
Background
An important component to efficient and successful medical diagnoses and interventional decisions are results obtained from clinical laboratory tests and point-of-care devices (such as pulse oximeters and glucometers), which can provide insight into physiological states within a patient that are not directly observable. However, many of these clinical diagnostics do not reflect the diversity of patient populations, often utilizing non-biological parameters as a proxy for diversity. As a result, clinical diagnostics suffer greatly from a diversity issue, causing underrepresented groups to receive inferior medical treatment and in some cases can cause complete loss of opportunities for early diagnoses.
During the development phase for these clinical diagnostics, it is often the case that inadequate attention to biological diversity of patient populations leads to the release and utilization of many assays / devices that work best for only select populations and may disadvantage populations that experience health disparities. The purpose of this NOFO is to promote the development of improved clinical diagnostics or the development of alternative clinical diagnostics that address health disparities created by clinical laboratory assays and/or point-of-care devices that fail to incorporate diverse patient groups. This NOFO aims to engage and support small businesses in providing seed (i.e., early-stage investment) funding for developing solutions to a clinical diagnostic or group of clinical diagnostics that perpetuates health inequity and disparities that disadvantage African Americans, Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, disadvantaged socioeconomic groups, underserved rural populations, individuals or groups with disabilities, and sexual and gender minorities.
Research Objectives and Specific Areas of Interest
Under this NOFO, research may take place within the context of existing clinical diagnostics within established health care settings or may involve the proposal of new clinical diagnostics. Applicants will need to provide a clear vision of the proposed clinical diagnostic, who would be the consumer of this diagnostic, and how they plan to take this technology to market. Applicants are strongly encouraged to reach out to the Federal Drug Administration (FDA) to ensure that what they develop will meet the approval requirements of the FDA for usage of this technology in a clinical setting. Applicants must develop clinical diagnostics that are as accessible or more accessible to HD populations than currently available diagnostics and should meet or exceed the quality of existing diagnostics. Applicants are encouraged to consider aspects of social determinants of health (SDOH) during the development process, though SDOH should not be the sole focus of their project. Applicants should include a plan for including input from relevant HD populations to ensure the needs of the HD population are addressed.
This NOFO accepts different types of projects with the intent of developing clinical diagnostics that address patient inequity and healthcare disparities including, but not limited to, the following:
Novel technologies that address a quantifiable, known issue in an existing clinical diagnostic that perpetuates health disparities, such as pigment variation and its relation to light absorption in imaging and point-of-care devices.
Novel technologies utilizing equitable parameters to replace clinical diagnostics that incorporate non-biological parameters, such as race.
Projects that address health inequities in analytics or bioinformatics that support or are used in the development of clinical diagnostics, such as variant identification, annotation and interpretation in molecular diagnostics.
Projects associated with addressing and correcting health inequities in clinical decision support tools and/or software intended to be utilized in the clinical environment.
Pilot or small-scale projects that validate new technology designed to address an identified health disparity within an existing clinical diagnostic.
Larger-scale studies for which pilot data or small-scale success for correction of a health disparity has already been documented, but which need further development to enter the market.
Examples of activities and corresponding SBIR Phase assignment includes but is not limited to the following:
Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and determine the quality of performance of the small business recipient organization before proceeding to Phase II.
Phase II. For small businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, NIH can issue a Direct to Phase II award. The NIH will accept Direct to Phase II applications regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Direct to Phase II awards should be submitted as “New” applications and not continuations ("Renewal") of Phase I SBIR or STTR projects. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase project period.
Fast Track. In an NIH STTR fast-track both Phase I and Phase II are submitted and reviewed as one application to reduce or eliminate the funding gap between phases. Fast-Track (Phase I/ Phase II) applications should:
Include a clear rationale of the technical and commercial feasibility of the proposed approach and technology
Demonstrate a high probability of commercialization through a commercialization plan that describes the long-term commercialization strategy and details of any independent third-party investor funding that has already been secured or will be provided during the Phase project period; and
Include specific, measurable, achievable, relevant, and timebound milestone deliverables. It is important to clearly state the go / no-go milestone(s) that will determine transition to Phase II and indicate potential Phase III support/interest (non-STTR) from future commercialization partners.
For Fast-Track applications, an administrative review will be conducted by NIH Program staff to decide whether a project will be considered for transition from the Phase I to Phase II. Phase II eligible projects must successfully accomplish milestones of Phase 1 as defined in Milestones Plan. Funding for the Phase II application will be contingent upon (1) assessment of the Phase I progress report and determination that the Phase I goals and milestones were achieved; (2) an update (as necessary) of the Commercialization Plan; (3) determination of the project's potential for meeting the mission of the awarding component and for commercial success; (4) review and approval of other documents necessary for continuation; and (5) availability of funds. The continuation application package is due 2 months prior to the anticipated start date of Phase II.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases. For information on NIAMS SBIR/STTR program, please refer to https://seed.nih.gov/NIAMS_SBIR_home.NIAMS will not support clinical trials with this NOFO.
Sexual & Gender Minority Research Office (SGMRO)
The SGMRO coordinates research and activities related to the health and well-being of sexual and gender minority (SGM; defined for NIH research in NOT-OD-19-139) populations by working directly with the NIH Institutes and Centers (ICs) and serves as a liaison for the research community to ensure SGM populations are considered and represented in research activities across the agency. The SGMRO does not have grant-making authority and can only support grants selected for funding after review by one of the ICs participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant scientific/research contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021-2025, the FY 2021 NIH SGM Research Portfolio Analysis, and the office’s Research Resources webpage.
For this NOFO, SGMRO encourages research across the life course that focuses on the clinical diagnostic needs of and diagnostics- and device-based inequities faced by SGM populations and SGM people who are members of other populations that experience health disparities and inequities (link). When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework, NIMHD Research Framework).
National Human Genome Research Institute (NHGRI)
The National Human Genome Research Institute (NHGRI) strives to improve the health of all humans through advances in genomics research. The NHGRI Small Business Program encourages research and development applications with commercial potential that are comprehensive across the genome or are generalizable across variants, tissues, diseases or functions. NHGRI priority areas are described in the NHGRI 2020 Strategic Vision and generally fall into one or more of the following research areas: 1) Genomic Technology Development; 2) Genome Structure and Function; 3) Computational Genomics; 4) Genomic Variation, Population Genomics and Disease; 5) Clinical Genomics and Sequencing; 6) Genomic Medicine Implementation and Evaluation; 7) Ethical, Legal, and Social Implications of Genomics; and 8) Genomics Training and Education.
