The Hb Now: A Simple-to-Use, Low Cost, Novel POCT for Anemia

We are developing a low-cost device for anemia management with remote monitoring for resource scare settings. Anemia is a condition in which blood does not have enough healthy red blood cells, or enough hemoglobin (Hb) within blood cells, to deliver oxygen to the body. There are >1.8B cases of prevalent anemia worldwide, making it the most common blood disorder globally. Major symptom are fatigue, weakness, dizziness, and shortness of breath. Severe anemia can be life threatening, especially for older individuals. Anemia is a major cause of childhood stunting and wasting, low birth weight, childhood obesity (due to lack of energy to exercise), hindered school performance, and reduced work productivity. Thus, prevalence of anemia impacts the individual, family, community, and greater society when left unmanaged.

As an indicator of poor nutrition and/or poor health, anemia is one of the most pressing diseases in fragile health contexts. Rates of high anemia prevalence occur in areas containing undernourished populations and poor access to healthcare, with 89% of cases occurring in developing countries. Even in developed countries, anemia rates are higher in historically underserved populations, such as those containing high rates of ethnic minorities, underfunded communities, and those living in food deserts. Maternal and infant anemia are of particular concern, with an estimated 42% of children < 5 years of age and 40% of pregnant women worldwide being anemic. Due to this, the World Health Organization identified the prevention and treatment of anemia as a high-priority objective in the UN Sustainable Development Goals (SDGs) report in 2012, with the intention of halving anemia prevalence in women of reproductive age by 2030.

Anemia is preventable and treatable in most cases. However, screening is not widely accessible due to cost and technical requirements. Furthermore, point-of-care assays for red blood cells and/or Hb lack the holistic picture necessary for anemia management, including diet tracking, personal demographics, and other pertinent health data. These limitations severely hinder the utility of current standards of care, thus permitting poor health outcomes in anemic populations. The Hb Now is a more affordable point-of-care test for blood Hb levels linked with a mobile app for secure health data tracking and remote dissemination to experts and care providers. The device is robust and portable and comes with app-based pictographic directions of use, making it usable by untrained individuals. By deploying this platform in fragile health contexts, each individual can create a personalized health plan while trends at the population level can be rapidly identified to drive informed decision making. This will have a substantial impact on worldwide anemia management by making it affordable and technically feasible to monitor at-risk populations remotely and drive policy and decision-making regarding resource allocation and the provision of care.

The Hb Now is a low cost and minimally invasive device for testing blood hemoglobin (Hb) levels and managing pertinent health data that can be deployed for home use, local care, and field settings. It requires only 10 mL of blood from a finger-prick and reads in less than 20 seconds. A paired mobile app dashboard displays and stores result history while also providing demographics, age, gender, diet, and medication tracking with encrypted remote dissemination and communication with healthcare providers. Data integration distills complex health information to produce personalized health assessments for individuals and invaluable analytical capabilities at the population level. The affordability and remote connectivity make Hb Now an extremely valuable tool for deployment in fragile health contexts.

The Hb Now is centered around a handheld meter populated with a panel of LEDs and photodetectors capable of measuring colorimetric changes quantitatively. Test strips are comprised of four laminated membrane layers: a spreading mesh to laterally disperse the cells, a primary membrane coated with lysing agents and buffer to completely disrupt the cell walls and liberate free Hb, a secondary membrane to capture cellular debris allowing for free lysate to flow through and containing sodium nitrate and sodium azide to generate azide methemoglobin, and finally an optical membrane to control the absorption of the azide methemoglobin and impede light transmittance to provide optimum reflectivity. The end-color intensity, in percent reflectance (%R), is measured at a wavelength of 570 nm using a green LED. The %R is proportional to the blood Hb concentration, which is reported as g/dL.

The Hb Now mobile app guides the user through the testing procedure using universal and easy-to-follow pictographic directions of use. The mobile device also receives and transforms the data from the meter to display and store result history. The app allows for the tracking of patient information, demographics, diet and activity, medication, and more. Organizing all pertinent health data in a wireless mobile format provides an avenue for remote dissemination and communication to healthcare providers or other experts.

In home settings, the directions of use will guide untrained individuals to take a minimally invasive sample and receive accurate results quickly. In other settings, such as a local clinic or field setting, a single user can rapidly assay multiple patients in a row. All results and other health data will be linked to a personal Patient ID and will be stored on the mobile device or can be backed up to a cloud server. Users or their caregivers will be able to upload, manage, and track all pertinent health information including Hb level history via logging into the app. They can also interface with experts or clinicians remotely. Our innovative test strip, meter, and mobile app platform is highly versatile and provides clear, actionable health information regarding one of the most pressing diseases worldwide. Thus, it serves as an excellent solution to broadly improve health outcomes in fragile health contexts. 

Anemia is the most common blood disorder in the world and disproportionately affects underserved populations such as those with little to no access to nutritional foods, weak or nonexistent health systems, high rates of poverty, institutional inequities, ethnic minorities, and especially women and children. In 2019, there were 1.8 billion prevalent cases of anemia across the world, or about 23,176.2 per 100,000 population, accounting for 50.3 million years lost to disease (YLD). There is a negative association between socio-demographic index and rate of anemia, suggesting that the burden of anemia is more severe in regions with lower socio-economic development. The areas with higher anemia prevalence are Sub-Saharan Africa and Central/Southeast Asia, with Zambia, Mali, and Burkina Faso showing the highest rate. The populations in these countries are already extremely fragile due to a lack of nutritional food items and lack of healthcare access.

In higher-income countries, anemia prevalence continues to be driven by poor nutrition, specifically iron deficiency. Within these countries, historic inequities, institutional inequality, and under funding has left large swaths of population with little to no access to nutritious food (food deserts) and severely lacking access to healthcare and education. Additionally, these underserved populations are generally populated by historically underrepresented populations who are already at an increased risk of health-related issues. Furthermore, on the whole anemia affects most prominently women, newborns, and children. Women can lose red blood cells via menstruation, suffer increased nutritional demands during pregnancy, and can show reduced red blood cells due to transfer to the fetus. Thus, the management of anemia will have a profound impact on maternal health. For children, the risks from anemia are more severe. Anemia is most prevalent among children less than 10 years of age due to nutritional deficiencies, exacerbated by breastfeeding mothers who are anemic themselves.

Our solution will provide a more accessible, affordable, and actionable method of measuring blood Hb levels to diagnose, monitor, and manage anemia. The affordability, ease of use, and remote connectivity of the Hb Now gives it a clear and significant advantage over current standards of care. The device can be utilized in the home for anybody who needs to track their own Hb levels. It can also be deployed in local clinics or field settings to rapidly test multiple patients. Health tracking via the Hb Now mobile app can link blood Hb over time to pertinent information such as demographics, diet, medication, etc. Remote dissemination of data to healthcare providers or experts can drive informed treatment decisions at the individual and population level. This will increase local capacity and resilience in the health system, enable informed interventions, investments, and decision-making, improve accessibility and quality of health services for underserved groups in fragile contexts around the world, and enable continuity of care, particularly around primary health, complex or chronic diseases, and mental health and well-being.

The mission of IVDS is to create scientific solutions to improve the quality of life through timely, accessible, and actionable diagnostic information. We envision a world where individuals can take control of their health with personalized data and insights obtained anytime, anywhere. Thus, we aim to create point-of-care diagnostic platforms in which multiple biomarkers can be detected, measured, and monitored, with a focus on affordability, speed, portability, and remote dissemination of data. With this mission, IVDS has been a pioneer within the space developing a number of point-of-care tests for historically underserved conditions, including phenylketonuria, G6PD deficiency, long-chain fatty acid oxidation disorders, and deficiency of adenosine deaminase 2 (DADA2). Besides our more than 30 years of extensive technical experience, 10 commercial products, over $US 7 million in NIH funding, $400,000 in NJ State awards,18 successful Small Business Innovation Research (SBIR) awards, and 6 patents, the true key to IVDS’s continued success is in our relationships with patients and caregivers. We have developed and maintained these key stakeholder relationships over the years in order to hear directly from them about what they need, how we could help, and what steps we need to take along the way. For example, IVDS has frequent team meetings with representatives of patient advocacy groups (The National PKU Alliance, Homocystinuria Network America, and the DADA2 Foundation), clinicians and experts, and patients and caregivers directly before and during the development of our tests. For Hb Now, IVDS works closely with Bernard Okech (Uniformed Services University of the Health Sciences, Bethesda, MD), Michael von Fricken (George Mason University, Fairfax, Virginia), Ben Ley PhD (Menzies, Australia) and Dr. Lorenz Von Seidlein (MORU, Oxford, Thailand). All are experts in public health in high burden countries and will support future clinical studies using Hb Now. IVDS has a team comprised of 3 PhD scientists with backgrounds in mechanical, chemical, and biomedical engineering, and a support team of 2 M.S. in biomedical and nutritional science and one B.S. in biology. The team is developing Hb Now under the direct guidance of both affected patients and the clinicians/experts tasked with serving them in the field, and their input, ideas, and agendas are at the forefront of the design and implementation of this platform. This ensures that our solution meets their needs.

IVDS has an injection molded plastic meter design (I.F. Associates Inc., Allenwood, NJ) with PCBs (TouchPad Electronics, Mukwonago, WI) and LED array with final assembly occurring in-house. Test strips are manufactured in-house in a <25% humidity manufacturing space with a Yasui Seiki Mirwek automated coating system, custom slitter and membrane welder (Azco Corp., Fairfield, NJ), and a semiautomated process for assembling and singulating test strip cassettes. We have an Hb Now mobile app that connects with meters via Bluetooth, supports Patient ID entry, walks users through sample collection and directions of use, and reports a calculated Hb level (g/dL) based on the received reflectance (%R) values from the meter with a stored test history.

The Hb Now is not yet on the market.

The initial funds from Solve will be used to supplement the ongoing operations of IVDS, such as completion of clinical studies, FDA 510k submission, and marketing of the platform. Furthermore, IVDS seeks the invaluable connections that the MIT Solve network provides. The core values at IVDS include a focus on patient-centric solutions, and this lines up well with the Solve core values such as optimism, inclusive technology, and human-centered solutions. We will benefit greatly from becoming part of the Solve network and, likewise, we anticipate that our goals and experience can be of great value to others within Solve. Specifically, IVDS seeks technical and logistical support for developing a web-based personal health dashboard that consolidates information from the Hb Now mobile app to provide informational visualizations, health assessments and/or suggestions, actionable health trend identification at the population level (e.g., to spur governmental action), and supports high impact longitudinal studies over time.

The Hb Now is a novel device for testing blood Hb levels. The price for the meter and the test strips are substantially lower than that of current point-of-care standards, thus making it more accessible in low resource areas. It also provides holistic health monitoring, including diet tracking, which gives it great utility for anemia management for individuals and across large populations. Remote dissemination of the data will allow for rapid and informed decision making for caregivers, healthcare experts, and government policy. There is no need for additional equipment, calibration, user training, or extended turnaround time. By providing convenient Hb measurement to the most fragile communities and connecting them to remote clinicians locally and worldwide, we will see broad, positive impacts to global anemia management. This revolution in the standard of point-of-care Hb measurement and health monitoring makes Hb Now innovative.

The goal at IVDS for the next year is to complete verification and validation on the manufacture of meters and test strips, complete clinical studies, and begin the FDA 510k approval process. IVDS has already completed first articles inspection of meter and test strip molds, and we have produced a mobile app for the end user. A manufacturing space kept at 25% humidity, a Mirwek coater, an automated membrane slitter, a pneumatic cassette press, and a cassette slitter are available in-house and verification and validation lots can be produced. Clinical studies are expected to begin by Q4 of 2023 to test the accuracy and usability of Hb Now for new users. IVDS expects that the 510k process should go well because the assay is substantially equivalent to other spectrophotometric Hb tests. Within five years IVDS expects to be marketed globally with the first emerging markets being located in the US, Southeast Asia and Africa through clinical and industry partners. IVDS hopes to deploy Hb Now in the US in high burden communities such as those in food deserts or without access to quality healthcare.

IVDS works with a point-of-care regulatory expert to guide us through the clinical study, approval, and marketing process for our platform. Our progress will be measured by market adoption and feedback from users worldwide. The greatest impact we wish to achieve with Hb Now is a significant reduction in mortality associated with anemia. Furthermore, through the management of anemia, we wish to see a reduction in years lost to disease (YLD) due to anemia. We also hope that the remote monitoring of anemia via Hb Now will identify areas or populations at high-risk and allow for immediate and actionable solutions at the local level. Our progress will be well aligned with the UN Sustainable Development Goals including Goal 3: Good Health and Well-Being, Goal 5: Gender Equality, and Goal 10: Reduced Inequalities, which have progress indicators including reduction of maternal mortality and preventable deaths of children under 5, eliminating inequalities between genders in healthcare, and reducing racial inequalities in healthcare. An affordable, portable, and wirelessly connected device for managing anemia will have a significant impact on all of these goals.

Anemia is a widespread public health issue associated with poor prognosis, especially in pregnant women and children. Chronic anemia affects childhood development, cognition, growth, school performance, the ability to fight infection, and productivity across all ages. Early diagnosis and blood Hb monitoring is imperative and would have a significant impact if widely available. Those in fragile contexts with the highest risk for anemia often have no avenues of anemia management, and thus the effects are much worse in these populations. In resource poor settings, an inexpensive and minimally invasive tool, paired with remote connectivity, would substantially improve anemia management thus avoiding the most severe short and long-term outcomes. Identifying at-risk populations via remote monitoring can also potentiate immediate action at the local level including clinical or nutritional intervention. By disseminating the Hb Now, anemia management can be brought into the most resource poor and/or underserved communities and monitored by experts worldwide to generate positive change and suggest solutions. Individuals can track their Hb levels at home while local clinics can mass screen populations for Hb levels. Personalized health tracking will allow for health management of individuals, while remote dissemination and analysis of data can provide populations level decision making. Thus, we envision Hb Now having an immediate impact on this severe condition affecting those in fragile health contexts.

The test strips are a vertical flow test strips with laminated membrane layers for sample processing and optical detection. The colorimetric indicators and excipients are optimized to provide high resolution of blood Hb levels within the analytical range. The meter is a low-cost, LED based reflectometer that is calibrated at the point of manufacture against NIST traceable color standards. The remote connectivity is driven by the prevalence of mobile devices and cloud server storage. The device is simple to use for even untrained individuals, and the mobile app is equipped with pictographic directions of use.

The IVDS team is well-diversified and all inclusive. We have scientists and leaders that come from all over the world, of varying ethnicities, and all genders and orientations. The CEO Robert Harper supports a scholarship at a local university (Rowan University) for financially challenged students and continues to host promising international scientists through the J1 Visa program. By focusing a large effort on anemia, IVDS will bring diversity, equity, and inclusivity to underserved populations worldwide by improving healthcare outcomes.

IVDS is currently funded by the NIH. The device will be marketed on a sales model with the procurement of test strips potentially becoming subscription based for high volume users. We manufacture low-cost meters and test strips in-house and are able to generate profit while keeping costs to the end user low. We plan to partner with Polymer Technology Systems (PTS) for the initial marketing and dissemination of the Hb Now. Polymer Technology Systems is in the business of supplying the highest quality point-of-care diagnostic products to the global health care market. PTS currently has the infrastructure and channels of distribution. Their products are represented in more than 100 countries worldwide. The data generated by Hb Now will also be valuable and will be of great interest to governments, non-profits, and food companies. Continued use of the platform and indicators of improved anemia management will drive the commercial viability of Hb Now.

We will sell our solution (test strips and meter) directly to users, caregivers, doctors, E.R.s, and clinicians. We expect that our initial customers will likely be organizations involved in global health worldwide in high burden areas. Test strips are single-use and disposable, and thus will represent a flow of revenue. Our price point and remote connectivity will make us preferable to existing alternatives. We anticipate by Year-5, the Hb Now Platform will generate over 9 million dollars.

IVDS, founded in 2017, has received over 7 million in funding from the National Institutes of Health and National Science Foundation specifically to develop quantitative point of care tests for diagnosis and monitoring of pressing diseases. IVDS has incorporated a coating system and slitter to mass produce test strip membranes. As well we have implemented a dehumidification system under < 25% RH to manufacture test strips. This is all done with SOPS under a Quality Management System. Our capabilities and expertise so far have gained us three ongoing contracts with outside companies looking to develop novel assays, thus representing a preliminary source of commercial revenue. We have two assays currently finishing Phase II studies (PKU Now for phenylketonuria and PreQuine for G6PD deficiency) and we expect to move those to market by mid 2024. Our intention will be to license or sell this technology to some of the major players with the infrastructure and channels of distribution to disseminate the test strip and meters to individuals, hospitals, and local clinics.