Vitascan iron deficiency test

The WHO has stated that “nearly all women are to some degree iron deficient,” and that “more than half of the pregnant women in developing countries suffer from anaemia.” ID often leads to anemia (IDA) and increases risk of hemorrhage, sepsis, maternal mortality, perinatal mortality, and premature birth.

Even though treatment by iron supplementation can be low cost and effective, it alone is not enough. A major bottleneck is in not being able to test people’s iron status widely and frequently enough to promote adherence to supplementation and monitor its effectiveness.

VitaScan’s fast and accurate finger stick ID test enables health workers and patients to take informed and immediate action with fewer follow-ups. The low cost, portability, and simplicity of our test will help us scale globally and provide iron testing to more people at higher frequency to improve supplementation efforts and decrease the risk of adverse pregnancy outcomes.

In the US alone, ID affects 25% of pregnant women and 41.7% of children under 5. It increases across trimesters from 7% to 30%.

Women with severe anemia have a 3.5 times higher mortality rate from obstetric complications. Moderate anemia is estimated to increase the rate of maternal mortality 1.35 times. More women have moderate anemia, so there is a gap in testing and the importance of preventing and treating anemia is underestimated.

Low income community members face a mix of lack of access to quality healthcare and inability to take time off to attend medical appointments and follow-ups. Additionally, we face a tremendous data gap since there is no quick and simple way to test for ID, and while iron supplementation is recommended during pregnancy, there is often little to no feedback on adherence or its effectiveness. Meanwhile, pregnant women need monthly testing to determine and then monitor iron levels and prevent anemia –requiring rapid, frequent, low-cost testing.

We believe that by enabling easy testing and tracking of iron status, VitaScan will lead to measurable health impact such as faster improvement of iron status through informed iron supplementation  and reduced rates of anemia during pregnancy.

VitaScan rapidly and easily tests for important nutrition related biomarkers from a finger prick of blood, with ID being our first target application. Functionally, VitaScan works like a glucometer. The user deposits a finger prick of blood onto our test cartridge and inserts the cartridge into the reader. In minutes, the reader analyzes the test and reports your body’s concentration of the biomarker tested. 

Technically, VitaScan uses lateral flow assay technology similar to a pregnancy test. However, unlike traditional tests that can only produce a positive/negative reading, our competitive advantage comes from our test being accurate enough to quantify biomarker concentrations directly from whole blood. This is critical for ID testing, since tracking of iron status requires quantitation to understand people’s different baseline values and absorption rates depending on their unique physiology. 

In clinical settings, this would enable same-visit testing, consultation, and treatment to allow expecting mothers to address their ID immediately. In the home, the test would connect with a VitaScan mobile app to connect the users’ nutrition health data to their overall health, healthcare professionals, and health solution recommendations to provide a complete service.

Our technology is protected by five patents exclusively licensed from Cornell University.

Our tests are developed to streamline the diagnosis and treatment of ID in pregnant women and young mothers from marginalized communities.

We conducted a pilot clinical study with the Heart to Heart (H2H) Campaign run by Weill Cornell Medicine and Hunter College. This campaign works with churches to offer free point-of-care diabetes and cardiovascular disease screenings and consultation to underserved communities of NYC, including uninsured and undocumented. H2H is designed to overcome barriers in healthcare:access to testing, return for treatment, stigma regarding cost.

Our study included participation in over 10 H2H events testing over 300 patients for ID using our device. The success of H2H makes it a strong model for a campaign to specifically serve pregnant women and women of childbearing age in similar communities.

Our other key population is women in limited resource settings. Our co-Founder and Board Member Dr. Saurabh Mehta is a Cornell Professor with expertise in international nutrition, maternal and child health. He runs several food biofortification programs globally and understands how access to rapid ID testing can improve the effectiveness of iron fortification efforts. Therefore, through similar pilot programs we can directly engage with international communities as we bring our test to commercial use.

Left unaddressed, ID leads to anemia, contributing to nearly half of maternal deaths worldwide. In developing countries 43% of non-pregnant women, 55% of pregnant women, and 42% of children under 4 are anemic. A prevalence of over 40% is of severe public health significance, as is the case in 82% of countries globally. Anemia is associated with premature births, physical and mental developmental problems which later affect emotional health.

Pregnant women and children are most vulnerable and they need frequent, easy, low-cost consistent testing and feedback. VitaScan will focus on marginalized communities and bridge the gap to accessible, quality healthcare.

The advent of rapid finger stick glucose tests revolutionized diabetes care because people were able to manage their diabetes more regularly while minimizing its burden on daily life. VitaScan can revolutionize ID and anemia care in the same way for maternal health. 

Currently the only way to test for iron status is with laboratory instruments, and therefore efforts to address ID suffer the same pitfalls of the US healthcare system in terms of high cost and limited access. Our rapid finger stick test improves the standard of care compared to lab testing, particularly for maternal health in marginalized communities. In such communities, access to healthcare is challenged in many ways, including: inability to take time off work in order to comply with clinic schedule and follow on appointments, uninsured status, stigma with regards to healthcare out of pocket costs, as well as compromised continuity of care, especially if more than one provider is involved. Moreover, during pregnancy testing must be more frequent and quickly linked to treatment as the rate of ID increases across trimesters from 7% to 30%.

VitaScan can be deployed in point-of-care settings that laboratory tests cannot reach, yet are often the first and perhaps only access to healthcare for many women. This includes both traditional Ob-Gyn clinics and community WIC centers as well as in the home or field clinics in international settings. In all cases it removes the burden of needing a follow-on appointment, promotes early treatment, and helps sustain treatment throughout pregnancy.

Our diagnostic technology is protected by 3 granted and 2 pending patents, which enables fast and quantitative testing using traditional lateral flow assay design. Lateral flow is the go-to platform for rapid assays, given their low cost and ease of use. These perks are traded for poor accuracy, limiting lateral flow to qualitative yes/no reporting such as pregnancy or disease testing. However, unlike pregnancy or disease test requirements, all women have iron. A test is therefore only useful if it is quantitative, so that patients can understand their baseline values and how it changes over time to assess the effectiveness of treatment. 

We developed biochemical methods along with imaging and image analysis methods to dramatically improve assay sensitivity within the traditional lateral flow architecture. For example, we have developed protocols that use paper pads to separate nutrition biomarkers of interest from their binding proteins. With this, we are able to obtain quantitative accuracy near that of laboratory instrumentation with a test that maintains the low cost and ease of use benefits of lateral flow.

The core technology has been featured in over 20 academic publications. A few key papers are listed below:

https://pubs.acs.org/doi/10.1021/acs.analchem.9b00704

https://www.pnas.org/content/114/51/13513.full

https://pubs.rsc.org/en/content/articlelanding/2014/LC/C3LC51194D#!divAbstract

Within VitaScan we have also piloted the ferritin test in collaboration with the Heart to Heart (H2H) Campaign operated by NewYork-Presbyterian Hospital, Weill Cornell Medicine, and Hunter College School of Nursing in various New York City Boroughs. Briefly, H2H events work with community leaders to set up mobile health clinics and offer free health testing and consultation. Through an IRB-approved research protocol we set up a VitaScan ID test booth at these events and tested over 300 participants. Our 10-minute finger stick test demonstrated 94% R2 correlation to laboratory serum testing.

We believe that informed health leads to improved health. In the case of maternal and child ID, a main bottleneck that contributes to its high prevalence is lack of access to testing. We plan on partnering with organizations such as Planned Parenthood and WIC that facilitate access for marginalized communities, as well as run pilot studies to engage with customers early. While VitaScan is working on getting FDA clearance, we will run outreach campaigns to address stigma around high testing costs. The outputs will be increased frequency of testing for women and children and increased access which leads to filling in the data gap of the prevalence of IDA in low-income communities.

In the short term, our aims are lowering the rates of ID in pregnant women and obtaining an accurate count of ID cases in low-income communities. This will give more information on how to support these communities.

In the long term, our vision is to have IDA rates lowered, allowing for proper growth and development in children, physically, mentally and emotionally. Our goals are to improve the overall health of these communities and to shift to preventative healthcare and fewer issues in the future. This will be beneficial to both individuals and governments, as it saves money in the long run.

Research has linked increased public knowledge of nutrition and behavior change. For example, between 1992 and 2000 the US population that took vitamin A and calcium supplements jumped from 5% to 12%, which coincided with increased research and media on benefits of these micronutrients [Millen].

We have also conducted a 250-person survey, which presented respondents with 2 statements. The first statement was “I take or would take iron supplements as a precaution,” with which 20% of respondents agreed. The second statement was “I would take iron supplements if it was recommended based on VitaScan results,” with which 60% of respondents agreed. Respondents also explained why, for example saying “Knowledge is power, so knowing I had a deficiency of something would make me change my eating and supplement habits.” (Female, 35-44 years old, doesn’t take supplements).

Current: We are pre-sales since our test needs to obtain FDA clearance first.

1 year: we project selling 250,000 tests, including domestic and international markets.

5 years: we project selling 17,000,000 tests.

During the next year, we will get FDA clearance and develop partnerships with groups like WIC, allowing us to better serve low-income communities. With our easily scalable technology and already optimized lateral flow assay design VitaScan is exploring partnerships with contractors to mass produce.

Over five years, our goal is to expand nationwide and to other countries. In the context of a pandemic, many medical services are put on hold. In marginalized communities already deprived of resources, the situation is even more dire. Given the nature of our test, we plan on organizing drive-through ferritin testing with WIC centers to determine ID status and improve the quality of care women receive before and after the birth. Nationwide testing of iron status would lead to:

1)     Bridging the data gap and better understanding the percentages of maternal deaths worldwide caused by IDA.

2)     Reduce the rate of IDA in pregnant women and children and in turn the maternal mortality rates as well as infant death rates. 

3)     Raising awareness. Currently there is insufficient data regarding the causes of maternal mortality in marginalized communities. Very often the focus is put on the victim’s behavior and health choices and not on medical conditions.

Once we implement iron testing at a nationwide level, we will look to address ID by WHO region. Leveraging our connection with Cornell University, we  aim to address marginalized areas in the Americas which have a 20% anemia prevalence in children under 5 and 35% in pregnant women.

Prior to commercialization, VitaScan requires a strong regulatory strategy. From a legal standpoint, our procedures, quality assurance and quality management systems need to be designed and implemented correctly and consistently. FDA approval is possibly the largest market barrier for entry, aside from the complexity of the process, it also constitutes a large financial hurdle of upwards of $500k.

In terms of bridging the data gap and implementing wide-spread supplementation programs, our biggest hurdles are disparities in health coverage and lack of access to healthcare, which prevent wide-spread testing and patient retention.

There are health coverage disparities across plans and the coverage they offer, as well as the difficulty of choosing a healthcare plan when earning too much for Medicaid but being unable to afford private insurance. Furthermore, if applying for Medicaid, it may take months for the application to go through, which is too long for pregnant women and mothers.

Additionally, rural America has a significant lack of access to healthcare, a shortage of healthcare professionals, lack of specialist care and of evidence-based protocols. Maternal healthcare services are some of the first to be eliminated as they are expensive in terms of length of labor, supplies, personnel and offer low to no reimbursement. Lack of access and elimination of maternal healthcare services become increasingly dangerous for mothers and pregnant women during a pandemic.

VitaScan has completed a 510(k) pre-submission meeting with the FDA. Based on discussion with the FDA and our regulatory consulting firm, we expect a straightforward path towards clearance as a Class II medical device due to relatively low regulatory burden of a minimally invasive nutrition test. VitaScan has also begun developing and implementing a quality assurance and quality management system consisting of standard operating procedures, forms, dynamic lists and work instructions. 

VitaScan has a sustainable business plan even for uninsured patients. Our low cost per test makes us ideal for addressing lack of healthcare due to financial reasons. During transfer to manufacturing, keeping costs low will remain a top priority. VitaScan also develops clear utilization protocols and will work with clinicians to implement protocols for supplementation and retesting.

Lack of access can be addressed by partnering with organizations offering point of care testing and maternal health services, such as WIC or Planned Parenthood. Collaboration is critical in order to convey to residents of low-income communities that our test is accessible to them and eliminate any stigma regarding costs.

We will also seek to form a network of point of care providers in remote areas, to better manage our program. VitaScan eliminates the need for additional specialists or providers, so our services can be implemented easily in remote, rural areas and marginalized communities.

2 full-time. 1 part-time. 2 contract firms (1 manufacturing and 1 regulatory).

Li Jiang, PhD (PI) is co-Founder and CEO/CTO of VitaScan. He has 10+ years of experience in developing diagnostics and mobile health technologies. He obtained his PhD in Mechanical and Biomedical Engineering from Cornell University, where he developed novel molecular diagnostic technologies for use in resource-limited settings. Dr. Jiang has led VitaScan through a DoD Phase II project, completed three IRB studies with various partners for VitaScan’s beachhead tests, and is leading efforts with VitaScan’s manufacturing partner to bring its beachhead ID assay to market. 

Alexandra Voinea is Lead Product Development Engineer. She first joined as an intern while earning her MEng in Systems Engineering at Cornell University, then joined full time after graduating. She oversees product development, quality assurance and the quality management system.

Hassan Bennani, MD is VitaScan Chief Business Officer. He has 20+ years of experience in product development, business development, sales and marketing of diagnostic devices particularly in women’s health. Prior to joining VitaScan, Dr. Bennani served as VP of Adeza Biomedical, helping it grow from a $3M start-up through its $450M acquisition.

Advisors. Professor David Erickson (co-Founder, Chairman) is SC Thomas Sze Director and Sibley College Professor of Mechanical and Aerospace Engineering at Cornell University. He is the co-founder of Halo Labs, a commercial manufacturer of nanoparticle analysis instruments. Professor Saurabh Mehta (co-Founder, Board Member) is Associate Professor of Global Health, Epidemiology, and Nutrition at Cornell. He is a physician and epidemiologist with expertise in infectious disease, maternal and child health, and diagnostics.

NewYork-Presbyterian Hospital: In 2019 we completed a pilot clinical study with Weill Cornell Medicine/NewYork-Presbyterian Hospital through their Heart to Heart (H2H) campaign, in which we tested around 300 participants and validated our assay in community clinic settings. We will implement similar models for community health outreach used by H2H in our ongoing partnership and future ones to continue our engagement with underserved communities.

America’s Blood Centers: We are working with America’s Blood Centers to develop the test as an iron screening and management tool for blood donors. Specifically we conducted a pilot study with member organization Mississippi Valley Regional Blood Center at one of their blood draw events to study and develop the protocol for incorporating our test into their practice. Ultimately our test will be used when a donor first visits a site to determine the donor’s iron status and make sure they have enough iron stores to donate.

Department of Defense/Cornell University: We have a grant provided by the Department of Defense to develop the ID test in collaboration with Cornell University. In this case, the test will help manage iron status in female military members, particularly during basic training and in the field, to make sure any deficiency is addressed before it develops into more severe conditions.

International Organizations: We have two partnerships with international organizations that are under NDA.

We will provide high margin, low cost, and easy to use disposable tests with a dedicated low cost reader. Our customer base can be split into three categories: 1) clinicians, 2) field clinic sites, 3) home users. We describe the value proposition for each.

Clinicians: For clinicians in traditional Ob-Gyn clinics and community centers like WIC, the biggest value in the test is time savings. Currently, to get the same information on iron requires a phlebotomy, mailing blood to a lab, and a follow-up: a call, letter, or in-person visit. VitaScan rapid test allows the physician to provide consultation and treatment to patients in the same visit.

Field clinic sites: For resource limited settings, the biggest value is being able to provide immediate results and consultation. In such settings, the majority of patients are lost in follow-up and the first visit is often the only opportunity for healthcare professionals to provide treatment and consultation. In addition to providing same-visit results, our test can be made at low enough cost to be economically viable and clinically useful.

Home users: For home users the value is in providing improved access and convenience. Particularly during the critical time of pregnancy, when a mother’s iron stores decrease more dramatically than normal, frequent testing is the only way to ensure adequate supplementation and management of iron status throughout the pregnancy. However, frequent physician visits are impractical and often impossible for many. VitaScan is the only technology that would enable at-home testing and management.

We have been supported so far primarily through non-dilutive grants and awards. We are seeking to raise capital now to fund completion of manufacturing transfer and clinical trials of the ID assay. With several early adopters and customers already lined up, we expect to achieve healthy revenue shortly after gaining FDA clearance. This revenue will be reinvested into R&D to develop tests for other biomarkers that would compliment our offerings. The same reader platform can be used for all pipeline tests, thereby reducing the barrier to entry for customers who already own the readers.

As a standard razor/blade model, early on the primary revenue stream will be individual test sales. The reader will be offered at steep discounts to facilitate greater buy-in and access to testing. Over time, as more tests are offered and conducted, aggregate test data can be analyzed to show not only overall health of populations, but also consumer behaviors, demographic information, and other important metrics. The data we collect can be monetized to help service and product providers to help them make decisions on their offerings and consumer engagement. In the long term, data monetization is likely to become a greater revenue stream than test sales. Our revenue model will then focus on creating a self-sustaining snowball effect in which revenue from data allows us to reduce test prices, which in turn incentivizes greater usage and produces more valuable data.

As a start-up focused on social entrepreneurship and serving underrepresented communities, we rely on community support and a strong network. This is our main reason for applying to Solve.

To fully address the disparities in health coverage and lack of access to healthcare, we need to be able to provide our tests independently of hospital and insurance networks and emphasize access in community care centers such as WIC and Planned Parenthood. We are seeking assistance in developing our network with such clinics and services to bring access to marginalized communities.

We also recognize the importance of informing people through campaigns targeted towards their communities and we hope to develop fruitful partnerships centered on outreach. We want to run campaigns that would inform communities about our programs and eliminate stigma regarding cost of care or insurance status.

We hope to build a tight network of partnerships with our peers in the Solve class, which would also help integrate different maternal healthcare programs and close the gap of services in low-income and marginalized communities.

VitaScan is on the path of transfer to manufacturing and additional funding would help accelerate our time to completing this, the clinical trials for FDA clearance, and ultimately commercialization. 

VitaScan is interested in partnering with APCO and UN Women, and would be interested in collaborating with Katja Iversen from Women Deliver.

We are seeking to partner with APCO worldwide to create outreach campaigns promoting consistent ferritin testing for children and women before pregnancy and each month during pregnancy. We need to convey a clear message to our audience through storytelling as that is the core of making strong connections with our stakeholders. VitaScan’s goal from our partnership with APCO is to develop a program that breaks through the background noise and distinguishes itself through engagement and targeted communication. This will drive interest in our product, increase testing rates and public awareness regarding ferritin status.

VitaScan’s goal of reducing mortality rate and increasing positive pregnancy outcomes is aligned with the mission of UN Women. Knowledge of ferritin status leads to empowerment to take action over one’s own health outcomes and in turn increase quality of life of women and children. Our program of ferritin testing is key to Governance and national planning and aligning policies with maternal healthcare goals.

Finally, we are interested in partnering with Deliver for Good through adviser Katja Iversen, specifically their investment in improving maternal and newborn health and nutrition.  Deliver for Good is interested in “clinical interventions and health services delivered across a continuum of care”. VitaScan’s point of care testing is able to bridge the access gap to healthcare services and easily facilitate continuous nutrient testing for children and pregnant women.

VitaScan works to streamline ID detection and treatment in order to improve the outcome of pregnancies and child development worldwide. In an environment where mothers are valued and protected and children grow physically, mentally, and in turn emotionally healthy, women have more room to grow and develop healthy, holistic lives instead of being stuck in a cycle of poverty.

The effects of anemia in women and children can be devastating.

According to the WHO, a prevalence of anemia over 40% is considered of severe public health significance. A total of 68 countries have severe anemia levels and 91 additional countries are at moderate level, affecting 82% of countries globally. Beyond acute critical conditions, anemia is also associated with conditions that affect long-term health, such as premature births and physical and mental developmental problems including learning deficits and eating disorders.

VitaScan offers a more efficient alternative to laboratory testing that can reach far more people but provide a rapid test with comparable accuracy in a portable, cost-effective manner. We envision worldwide expansion of our tests which would help decrease maternal mortality rates and close the healthcare gap for underprivileged communities.

All mothers deserve access to high-quality, affordable maternal care and our readers would lower barriers that low-income communities currently face to seeking care.

Iron deficiency anemia is a far-reaching problem that leads to both clear and hidden, long-term health problem. With 82% of countries considered by the WHO to be of moderate to severe public health significance for anemia, billions of lives could be impacted by our technology. Since iron deficiency has also been estimated to cause 4% median GDP loss in these countries, our impact goes beyond addressing primary issues in maternal and child health and can be a part of improving the global economy.

The Future Planet Capital Prize will help accelerate our time to market by supporting our clinical study towards obtaining FDA clearance.