Vitascan: COVID-19.Scan

SARS-CoV-2 may become endemic. Given its overlapping symptoms with seasonal influenza like H1N1, there is a critical need for a screening tool to distinguish between the two, should outbreaks of COVID-19 and influenza coincide.

We are developing a direct antigen 15-minute nasal swab test that tests for SARS-CoV-2 nucleoprotein and H1N1 nucleoprotein in a multiplex assay. When scaled, we can test patients while quarantined and minimize exposure at testing sites. By enabling accurate home-use testing, we limit exposure of negative individuals to the general population and of the general population to positive individuals.

Furthermore, the test would connect with a VitaScan mobile app to connect the users’ COVID-19 status with their overall health profile and associated risk status, healthcare professionals, and health solution recommendations to provide a complete service. Filling in this data gap would greatly assist contact tracing efforts and help control the spread of COVID-19 and influenza.

According to APM Research Lab’s “Color of Coronavirus”, the mortality rate of COVID-19 for Black Americans is 2.3 times as high as the rate for Whites. For Indigenous Americans, communities are hit disproportionately varying from state to state, in New Mexico constituting 59.7% of deaths. Black, indigenous and people of color also make up many essential workers, with low pay and severe lack of healthcare benefits. Therefore, they are both more exposed than the general population, and face a lower standard of care.

A COVID-19 outbreak could be most damaging to national health if it coincides with seasonal influenza, given that both share symptoms but require different treatments. It is therefore critical that we develop a tool in clinics and homes to rapidly and effectively distinguish between the two, and that we distribute it in centers most frequented by marginalized communities to better serve them.

By connecting the test with the VitaScan mobile app, we can efficiently track and compile cases in one database, whether the test was administered in a hospital, point-of-care clinic or at home. This would also eliminate waiting times between testing and identifying and treating cases and help obtain the relevant data to deploy contact tracing.

The complete COVID-19.Scan test will be a 15-minute nasal swab assay to detect SARS-CoV-2 and H1N1 nucleoproteins. It is designed to be suitable for CLIA-waived and home settings. VitaScan’s IP also covers the use of mobile devices like smartphones to read, interpret, and report test results. Our patented point-of-care technology enables multiplexing on a single lateral flow test strip and eliminates the risk of false positive readings caused by cross-reactivity. We have applied this technology to multiplexed assays for viral and parasitic infections and nutrition markers, among other applications.

In clinical settings, this would enable same-visit testing, consultation, and treatment. 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. This would allow individuals to address their status immediately and quarantine if necessary. It would also facilitate testing to obtain two negative results 24 hours apart to leave quarantine without the potential exposure associated with visiting a healthcare center. VitaScan is developing the assay and is seeking partnerships to deploy the test as widely as possible to generate the data required for efficient contact tracing.

Our tests are specifically developed to streamline the process of diagnosis and treatment, and can be used in a clinical setting, in point-of-care and community centers, as well as within one’s own home.

VitaScan testing is fast, accurate and provides rapid response. We return a result during the same visit and avoid exposure of patients to the public and of healthcare professionals to infected patients. Our affordable kits enable us to fulfill the key requirement of controlling the spread of COVID-19: widespread testing. VitaScan is easily scalable and can provide all communities, including low-income, with sufficient tests to diagnose, treat and track COVID-19 cases and prevent their spread.

VitaScan is experienced in reaching out to marginalized communities. We conducted a pilot clinical study in partnership 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 New York City, including the uninsured and undocumented. H2H is specifically designed to overcome barriers in healthcare, including access to testing, return for treatment, and stigma regarding cost of physical examinations.

According to APM Research Lab’s “Color of Coronavirus”, the mortality rate of COVID-19 for Black Americans is 2.3 times as high as the rate for Whites. In addition, minorities and members of marginalized communities make up most of the frontline workers including healthcare workers who are 54% non-white.

These segments of the population would benefit greatly from quick, accurate and affordable access to COVID-19 testing. Their employers could easily implement testing on-site, relieving some of the burden associated with getting tested, as well as anxiety from working in a potentially unsafe environment and being exposed to COVID-19.

The VitaScan test is affordable and easy to use in point-of-care centers and non-clinical locations. Unlike most of the currently used tests, we don’t require laboratory time and have an almost instant turn-around, speeding up processing time, reducing exposure as well as being able to acquire and manage more data to assist with contact tracing.

Efforts to flatten the curve and limit the spread of COVID-19 would be hindered by high cost and limited access. With our multiplex assay, healthcare providers can simultaneously screen for both COVID-19 and influenza and quickly diagnose and triage patients.

Our rapid test improves the standard of care compared to lab testing, particularly for 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.

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 individuals in low-income communities. Furthermore, the information can be sent and consolidated on a single platform regardless of whether the test was conducted in a hospital, home, nursing home or point-of-care center. Consolidated data will reduce the time between administering a test and obtaining the result and speed up contact tracing in high-risk communities like nursing homes.

Our diagnostic technology is protected by 3 granted and 2 pending patents, which enables fast and quantitative testing using traditional lateral flow assay design. Traditionally, lateral flow is the go-to platform for rapid assays, given their low cost and ease of use. However, these perks are often traded for poor accuracy compared to laboratory instruments.

We have developed several advanced lateral flow techniques that will be applied to ensure that we obtain independent accuracies for SARS-CoV-2 and H1N1. First, we incorporated differently colored fluorescent tags to eliminate cross-binding and enable a large dynamic range of detection. Second, we developed lighting, filtering, imaging hardware, and image analysis algorithms to improve quantification of low intensity fluorescent signals.

Previously developed procedures for integrating multiple biomarkers onto one assay will be used here to optimize the development process. The assay structure has a standard paper-based lateral flow design. The detection region will consist of 3 lines: one test line to capture SARS-CoV-2 nucleoprotein, one test line to capture H1N1 nucleoprotein, and one control line to serve as a positive control. We will use the fluorescent nanoparticles europium chelate microspheres and fluorescein as reporter probes because they typically provide the strongest limits of detection, with analysis provided by a portable reader instrument. We have used this and similar formats in the past.

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 a 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. The same technologies used for this test will be adopted for the COVID-19.Scan test development.

We believe that the most efficient way to limit the spread of COVID-19 is through widespread testing and contact tracing. Our platform can assist both.

Our affordable, easy to use assay ensures that testing is widespread across low-income, marginalized communities, including undocumented and uninsured members. The VitaScan test is very practical in the field, especially in the context of a pandemic when bringing large numbers of people in an enclosed space is not desirable.

While VitaScan is working on getting FDA clearance, we will run outreach campaigns to address stigma around high testing costs, complicated selection criteria and long processing times. We also plan to develop partnerships with community centers, point-of-care centers, essential businesses, schools and places of worship to facilitate a smooth start to contact tracing.

The outputs will be increased frequency of testing for minority groups who also represent frontline workers and increased access which leads to filling in the data gap of the prevalence of COVID-19 in low-income communities. As more data about COVID-19 is acquired and centralized, we can support contact tracing and limit the spread.

In the short term, our aims are flattening the curve and contact tracing to stop the spread of COVID-19, particularly during flu seasons, until a vaccine is developed and deployed.

In the long term, our vision is to have a platform that would ease contact tracing of any new or existing virus to limit its potential to generate another pandemic. By having a system in place, we are better equipped to react to the new viruses that will become more prevalent with climate change and globalization.

Additionally, with widespread testing and contact tracing, we can better bridge the healthcare gap to low-income communities and better serve and protect them. This will be beneficial to both individuals and governments, as it saves money and resources in the long run.

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

1 year: we project selling 250,000 tests, domestically.

5 years: we project selling 10,000,000 tests.

During the next year, we will get FDA EUA and develop partnerships with groups like community centers, schools, healthcare clinics and companies employing frontline workers, 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. 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 testing with point of care centers to determine COVID-19 status and improve contact tracing and limit spread within that community. Additionally, as the country goes through local outbreaks or waves of quarantining and reopening, we plan on collaborating with schools, workplaces, places of worship to implement widespread testing and allow re-entry in high density areas only after confirmation of negative SARS-CoV-2 status.

This will reduce the mortality rate of COVID-19 within marginalized communities, lessen the pressure on low-funded community healthcare centers, enable a network of contact tracing to control any future outbreaks and help monitor COVID-19 status until a vaccine is deployed.

Once we implement Sars-CoV-2 testing at a nationwide level, we will look to address COVID-19 status according to WHO regions, with a focus on low-income, marginalized communities and refugee camps.

FDA approval the largest market barrier for entry, and given the changing situation, FDA guidance is constantly updating. VitaScan therefore is building a strong regulatory strategy with its regulatory consulting firm. Our procedures, quality assurance and quality management systems will designed and implemented correctly and consistently. 

In terms of wide-spread testing, our biggest hurdles are disparities in health coverage, lack of access to healthcare and resistance to evidence regarding the severity of a resurgence in COVID-19 cases. 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 in the context of a pandemic.

VitaScan has obtained guidance from the FDA on this project and is designing its regulatory strategy accordingly. 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 community centers. Collaboration is critical to convey to residents of low-income communities that our test is accessible to them and eliminate any stigma regarding costs. We will also focus on local collaborations with schools, workplaces, grocery stores, places of worship to better track active cases and support contact tracing efforts.

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 clinics and community centers, the biggest value in the test is time savings and reduced exposure of both medical professionals and individuals seeking to get tested. Currently, to get the same information requires a nasal swab, mailing samples to a lab, and a follow-up in the form of a call or letter. 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 addition to providing same-visit results, our test can be made at low enough cost to be economically viable and clinically useful.

Home users: Here the value is in providing improved access, convenience and safety for themselves and their community. If they are Sars-CoV-2 negative, they don’t risk exposure, if they are positive, they don’t expose members of their community. Particularly during the resurgence of the virus simultaneously with influenza, frequent and wide-spread testing is the only way to ensure adequate contact tracing. However, frequent physician visits are impractical and impossible for many in the context of a pandemic. VitaScan would be among the first to 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. 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 widespread testing and contact tracing 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 Vodafone and the Inter-American Development Bank.

We are seeking to partner with Vodafone to facilitate widespread access to our mobile app in addition to testing. This will allow us to do more widespread contact tracing and consolidate a more complete database of COVID-19 status. Additionally we seek to create outreach campaigns promoting testing in the event of COVID-19 and influenza spreading at the same time. VitaScan’s goal is to develop a program that breaks through the background noise and distinguishes itself through engagement and targeted communication. This will inform the population about the importance of widespread testing and knowing your COVID-19 status to protect the more high-risk members of each community.

VitaScan is also interested in developing a partnership with the Inter-American Development Bank. Once we implement widespread testing and contact tracing within the US, we want to further expand into low-income, marginalized communities in Latin America and the Caribbean. IDB and VitaScan share a common goal to improve lives in underserved communities. Using IDB and their connections and partnerships with the Bill and Melinda Gates Foundation and the Carlos Slim Foundation, we can work to dramatically increase testing and diagnosis as well as contact tracing and prevention across Latin America. Moreover, we can assist in the development of a system of contact tracing that would prevent the escalation of any other potential upcoming virus.

VitaScan's portable, affordable test can be deployed in hospitals, clinics, point-of-care centers and nursery homes to test frontline workers and health providers. Under current conditions, nurses and doctors potentially exposed to COVID-19 have difficulty access testing. We plan to remediate that by prioritizing health care providers in terms of testing and contact tracing, both for their health and the health of the communities they serve.

It is likely that for the foreseeable future, regular testing and contact tracing will become a part of normal life, with flu seasons requiring even greater vigilance. Our proposal of a rapid 2-plex assay to improve access to testing two pandemic-scale outbreaks undoubtedly has the potential to impact millions of lives. The Future Planet Capital Prize will help fund development and optimization of our assay and accelerate its time to market.