Funding Opportunity to support the development of Point-of-Care Technologies in Nutrition, Infection, and Cancer for Global Health

Overview

The Point-of-Care Technologies for Nutrition, Infection, and Cancer for Global Health (PORTENT) Center is a one-of-a-kind international network of clinical, training, and device development facilities with worldwide expertise in point-of-care diagnostics, their application and commercialization. Our integrated core clinical and validation facilities across 4 continents in New York City, Uganda, Ecuador, and India, can help accelerate point-of-care technologies for a broad range of populations, clinical samples, and with a unique set of users. The PORTENT Center is unique in that it (1) Focuses on primary health care globally, (2) Addresses the needs of the most vulnerable in the US and internationally and (3) Enables a broad range of diagnostic technologies to be validated on a global scale while simultaneously developing expertise and strengthening capacity domestically and internationally.

Funding Opportunity

Through this opportunity, PORTENT will provide funding to teams developing point of care diagnostic technologies based on our criteria and those who need support for clinical validation, commercialization or regulatory expertise, manufacturing, training, or technology development skills to bring their product to market. Specifically, we aim to accelerate technologies that (1) are beyond the proof-of-concept stage and would benefit from clinical validation, (2) have been validated or even commercialized domestically but want to expand reach and have impact internationally, (3) have been developed/incubated by our international partners and show promise at addressing a market need locally or in the US. For this opportunity the term, “diagnostic” should be considered broadly and inclusive of technologies that enable accurate diagnosis, risk assessment, screening, monitoring of response to treatment or intervention, and promotion of wellness and health at the point-of-care.

Specific Criteria for Funding

PORTENT is focused on supporting development, clinical validation, commercialization, and deployment of point-of-care technologies for nutrition, infection, and cancer for global health in locations where access to better diagnostics can have the largest worldwide impact. We focus on technologies that address the primary needs of the most vulnerable in the US and internationally.

To meet this need, our 2024 PORTENT RFP identifies the following specific criteria for funding.

1. Proposals must show direct responsiveness to our annual needs assessment consensus addressing a specific issue in Nutrition, Infection or Cancer with a Global Health Focus as described in the Needs Assessment and Areas of Interest section below.
2. Proposals must have sufficient proof-of-concept evidence that they are likely to be successful in further development through PORTENT. This typically means that projects must be at the TRL stage 3-5. Please reference CIMIT's GAITS for more information.
3. Projects must identify an intended “setting of use” where their technology could have the greatest impact and describe:
   • How the technology is compatible with its intended “limited resource setting” of use which may include: home care settings, clinical settings, laboratory and primary care settings.
   • Demonstrate a pathway towards effective linkage to care, counseling, treatment or intervention if their diagnostic solution happens to be successful.
   • Demonstrate access to clinical care (prevention or treatment) in the diagnosed populations in the proposed setting of use.
4. Projects must identify the key barrier(s) to advancement and implementation of their technology. This may include (but should not limited to): clinical validation, manufacturing, prototyping, regulatory, customer discovery & commercialization, specific expertise needed. Are there ways the PORTENT center could help you overcome them?
   • The PORTENT Clinical Network represent key parts of our center. All selected teams are expected to participate in the PORTENT Knowledge Transfer workshops and Lab-2-Market accelerator. Details on these capabilities is available through the PORTENT website. How can these resources help address some of these key barriers?
5. A successful outcome for a PORTENT project is when a project achieves well-defined milestones that will allow it to advance towards commercialization. Proposals must identify these specific milestones at specific time points and describe how a successful outcome could advance the technology towards commercialization.

Expressions of Interest

Expressions of interest are due March 31, 2024 at 11:59PM ET and should be submitted here.

Funding Opportunity Details, Awardee Requirements, and Solicitation Policies

Total funds available 

$500,000

Number of projects anticipated 

About 5-7 awards with budgets ranging from $50,000 to $100,000 in total costs for projects up to 12 months in duration.

Additional Awardee Requirements

• Awardees are expected to review progress with the PORTENT Team monthly and provide progress reports at the 6- and 12-month points. Awardees are required to use CIMIT's GAITS to track progress at these monthly reviews.

• Awardees are expected to attend the PORTENT new project kick-off meeting and in-person PORTENT Annual Knowledge Transfer Workshop and participate in the Global Health POC Lab-2-Market bootcamp. 

Additional Solicitation Policies

• Animal studies and human clinical trials may not be proposed under this solicitation.

• 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.

• All expressions of interest, full proposals, and affiliated documents must be submitted through the online system by the dates and times outlined in the timeline. Late applications will not be accepted. Proposals should not include information which could be considered proprietary.

Needs Assessment and NIH Institutes Areas of Interest

Global Health Impact of Nutrition, Infection and Cancer: The regularly updated Global Burden of Disease data illustrates the top causes of mortality and morbidity, both in the US and globally, along with their risk factors. Infectious Diseases and Cancer are responsible for millions of deaths every year globally and also accounts for several million disease adjusted life years lost. Cancers account for 250 million plus disability-adjusted life years and are the second ranked cause of disease burden globally. Similarly, infections, including the scourge of antibiotic resistance and sepsis, exact a heavy toll in terms of both qualities of life and lives lost both in the US and internationally. Major infections including tuberculosis, HIV, enteric infections, malaria, and neglected tropical diseases collectively account for more than 400 million DALYs with the numbers much higher when COVID-19 is included. Many of the infections that we believed to have been controlled in certain parts of the world have re-emerged or become difficult to manage because of antibiotic resistance; new ones emerge with recent pan/epidemics such as those of SARS CoV-2, Ebola, and Zika viruses; continuing diseases such as Tuberculosis; and with climate change inflicting catastrophic damage to both lives and the public health infrastructure, the health community has to be prepared for other ones.

Nutritional deficiencies individually account for nearly 50 million DALYs. In addition, they are also one of the biggest risk factors for most of the other disease causes included. The interplay between nutrition and health is well established - poor nutrition predisposes to risk of disease as well as severity - and disease itself leads to worsening of nutritional status. The importance of nutrition cannot be overemphasized, given that nearly 2/3rds of the US population is obese or overweight, and an estimated 1 out of every 3 individuals globally has one or more micronutrient deficiencies, a number which may be substantially higher depending on setting. Today we recognize nutrition as one of the few truly 'modifiable risk factors' for health states. For example, the latest GBD analysis highlights nutrition-associated factors including healthy eating, diet diversity, maintaining a normal weight (high BMI), high blood pressure and high fasting glucose levels, and lack of regular exercise, constitute most of the risk factors across low and high resource settings. Further, a third of all premature deaths in the US, such as those due to non-communicable diseases (e.g., diabetes and obesity), are attributed to dietary risks (2). The global numbers are equally stark - deaths attributable to poor diets have grown by 15% since 2010, faster than the population growth, accounting for 26% of all adult deaths in a year, per the latest Global Nutrition Report.

The Role of Early Detection: A common thread to nutrition, infection, and cancer, is the key role of early detection. Diagnosing a malnourished state early can allows us to intervene to optimize nutritional status most effectively in a simple low-cost manner. For example, determining vitamin A deficiency in children early in its course can be easily reversed relatively without lasting sequelae with supplementation; however, waiting for clinical signs and symptoms such as night blindness to manifest carries a hefty price tag of greatly increased risk of mortality or permanent blindness. Detecting an infection early likewise is key to interrupting transmission as well as ensuring appropriate management along with antibiotic stewardship. Similarly, for many cancers, timely diagnosis is often the most critical factor for prognosis. These are the areas where POC technologies can have the biggest and immediate impact. By providing actionable information in real time along with the potential to create positive feedback loops to influence behavior, POC technologies can truly transform the health care landscape around the world.

The Impact of Point-of-Care in Limited Resource Settings: In resource limited settings, many diagnostic tests are cost prohibitive and inaccessible given limited laboratory infrastructure. Patients frequently travel great distances for clinical care yet cannot access routine testing. Clinical management is often guided by recognition of clinical syndromes, which may be inaccurate resulting in either inadequate treatment or overtreatment. In the case of presumed bacterial infection, undertreatment can be fatal yet overtreatment can result in unanticipated antibiotic resistance. Nutritional deficiencies that predispose to infectious diseases may also not be recognized due to lack of symptoms. Therefore, in all three domains of nutrition, infection and cancer, diagnosis remains the biggest gap in the cascade of care (from screening, diagnosis, and treatment) for many cancers in low resource settings thus precluding appropriate timely care. Even when facilities are available, personnel issues (particularly lack of trained pathologists) can delay diagnoses for long periods of time making it difficult to track down patients to return results. The combination of these factors means there is great potential to reduce morbidity and mortality through implementation of POC screening and diagnostic technologies and screening tests for infectious diseases, cancers, and nutritional deficiencies across all settings.

PORTENT 2024 Funding Priorities

For 2024 the PORTENT center will consider a broad range of point-of-care diagnostic technologies for funding which address priorities in Nutrition, Cancer, and Infection with a Global Health impact as described this section. For this opportunity the term, “diagnostic” should be considered broadly and inclusive of technologies that enable accurate diagnosis, staging or severity of disease assessment, screening, monitoring of response to treatment or intervention, and promotion of wellness and health at the point-of-care.

Areas of specific interest this year include, but are not limited to, the following:

• Diagnosis of nutritional deficiencies particularly those related to women’s health (including maternal and child health).

• Multiplexed screening and diagnostic assays for combined HIV and STI infection, acute febrile illness, neglected tropical diseases, and/or mosquito borne illnesses (e.g. Malaria, Dengue, Chikungunya). Specific STIs of interest include but are not limited to Chlamydia trachomatis, Syphilis, Trichomoniasis, and Neisseria gonorrhoeae. Technologies that can additionally assess the antibiotic sensitivity of the infectious agents (in all use cases) will be of particular interest.

• Broadening cancer diagnosis and risk stratification screening to community and clinic level, and in doing so addressing a neglected need of timely screening and promoting decentralization of diagnosis. Specific interest in gastric cancers, cervical, liver, breast, colorectal and lung cancers. This includes tests which screen for infectious agents known to be causative agent for  some cancers.

• Digital and AI (machine learning, deep learning, solutions) to support risk stratification, clinical staging, clinical decision making, promotion of health/wellness and encouraging use of behavioral lifestyle interventions.

• The development and validation of point-of-care technologies that can facilitate the integration of complementary and integrative health approaches into the management of diseases and conditions and/or promotion of whole person health, and well-being.

• Further areas of interest include those outlined by our sponsoring institutes (NIBIB, Fogarty, and NCCIH) as expressed in PAR-22-203. 

Technologies supported in 2024 should exhibit some or all of the following critical feature set:

• All technologies supported by this program must convincingly demonstrate that they are compatible with the “setting of use” described in the proposal and offer a distinct advantage over existing approaches.

• Projects must demonstrate how they are compatible with WHO REASSURED criteria for diagnostics.

• Projects should outline their key performance metrics for success. Depending on the specific technology proposed, this could include:

  • Primary importance: High sensitivity and specificity, convenient sample preparation, low cost, robust supply chain, ease of interpretation of test results, user-friendliness, and portability.

  • Secondary importance: Ease of specimen collection, time to test result, novelty of technology. 
     

• Technologies which promote connectivity with mobile networks to enhance data access to facilitate clinical decision making at the point of care and/or enhance quality control & conduct of tests, and that which incorporate modular designs that enable self-calibration will be of particular interest.

As appropriate, applicants should address how their technology meets the following additional development priorities:

• Local manufacturing capacity.

• Alignment with in-country needs.

• Consultations with and incorporation of input from stakeholders including ministries of health, health care workers, physicians and nurses.

• Availability or plans for a complementary toolkit including resources to enhance diagnostics literacy.

• Scale up marketing plans and follow up studies that demonstrate utility of device or technologies in practice settings.