AIEWS: An Airway Infections Early Warning System

At home, easy-to-use early airway infection identification test empowers individual treatment options and public health disease prevention   

Donald Rao, CEO of HunchDx, LLC, a start-up company dedicated to developing hands-free diagnostics devices for uniform and reliable disease diagnostics.

According to Worldometer, worldwide Coronavirus cases has surpassed 136 million with close to 3 million deaths.  The novel Coronavirus pandemic has imposed a grave threat to national economy all over the world, human society suffered devastating damages.  

With strong world effort and enormous vaccination strategy, the world is ready to be on the way to recovery.  The speed in Coronavirus spread caught the world by surprise.  While we are on our way to recovery, we ought to start thinking about how to prevent future spread of potential devastating pathogens to a pandemics scale.  The world now has tightly intertwined and interdependent international system allows relatively free flow of goods, services and people; unfortunately, the intertwined worldwide connectivity also leads to the spread of Coronavirus across the globe at an unsurpassed speed.  

An early warning of infectious agents at local outbreak is essential for the future infectious agent spread control and containment.  Infection control effort starts with sensitive detection and accurate identification of the pathogen, the requirement for sample collection by a health care professional limits broad implementation of surveillance programs.  Easily accessible and user-friendly pathogen identification tests linked to a privacy protected reporting system is needed for early warning.  

A child return home from school with a runny nose or slight cough, an adult feels lethargic with watery eyes, when one starts to feel slight headache with sinus involvements; does one know it is because allergy or a respiratory infection?  If a respiratory infection, is it bacteria pathogen or, virus? common flu or cold or more damaging infectious pathogen?  Shall one bedrest or visit doctor for antibiotic prescription.  School nurses see a lot respiratory symptoms, should the nurse report to school district public health office and what are the identity of pathogens?  Those are some examples of scenarios the AerosolEaseTM can serve.  AerosolEaseTM is intended to be an over the counter (OTC) product that is available to general consumers without prescription.  The non-invasive sample collection process and the at-home use provides ease and comfort at users’ own privacy.  The build in airway pathogen identification system enabling public health officials to determine the severity of occurrences and assess potential threat of identified pathogen to general public.  

The severity and wide-spread nature of COVID-19 pandemic has caught the world by surprise.  The major thrust of this Challenge is to help establish solutions so the world can manage better when another lethal pathogen surfaces.  Our proposed solution is to provide a fact-based early warning system on airway pathogen infection for individuals and for society.  With information and data provided from the test system, both individual and society will be prepared to manage the outcome.  In the long-term, we want to continue to improve efficiency and reduce the cost of our product to reach a wider population and to improve reliability of the early warning solution.  Working with world health authorities, we would like to provide in-kind supplies that is available to under-developed countries and under-privileged populations.       

Our solution starts from local level, with appropriate link, our solution can be extended to national and international level for the betterment of world health.  Data will be collected locally by local public health officials; the local information is fed into national database for analysis by national public health organization such as US Center for Disease Control (CDC).  Data can be further transmitted and communicated with World Health Organization (WHO).  Through local public health organization, CDCs and WHO, our solution can make strong impact on world health in general.  We will work with public health agencies worldwide to implement an efficient data collection process from our computer system.  Strong impact can be further extended to reach under-served populations.

After product launch, we will start an education and advertising campaign to let general public aware of our product and its use.  We will monitor the product usage and demand of our product.  We will be prepared to scale-up our production to meet the market demand.  Continue success in USA stipulates us to expand our manufacturing and marketing to other countries across the world.  We will work with WHO and nations worldwide to make our product and solution system available for licensed local production and application.  In order for the solution to be effective, we will need to have as many tests conducted and to reach all corners of the world.     

The impact of our solution is directly related to market acceptance of our product.  We will make every effort to design our product and the solution user friendly to encourage product use.  We will closely monitor our product demand and product distribution.  We will continue our education and advertising campaign all across the market areas.  We will also form focus groups to analyze product acceptance and discuss potential improvements.  Each individual group, culture or society may have different preferences and requirements, we will be diligently working to tailor our product and solution for different culture groups. Improvements will be implemented.

We have assembled an experienced scientific and engineering team together with tremendous experiences in product R&D, product quality control and regulatory path; we have sufficient experience to move forward with our proposed solution.  As usual, fund raising is a constant and continuous effort and a challenge.  We currently do not have large scale manufacturing infrastructure and online data communication expertise required for this novel solution; those are also strong barriers.  We need to resolve these barriers as we move forward in the coming year.  With networking through The Challenge, we hope to be able to overcome these barriers by forming partnerships that will carry our solution platform to reality.  Our novel concept, utilization of well-established technologies, and our patent landscape search showed a clear path forward.  We will constantly evaluate our formulations and our processes to determine whether to keep each formulation or process as a trade secrete or to seek patent protection.  Manufacturing costs and product price economy will be the key factors to sustain market presence and beat out copycats. Within the next 3 years, we will continue to work on reducing production costs by improving supply chain costs and improve production automation efficiencies.         

Before founding HunchDx, Donald Rao was Director of Interference Technologies at Gradalis and Strike Bio. Before Gradalis, Donald has worked on the scientific staff of ZymoGenetics, Abbott Labs, Neurogenetics.  Donald was founding member of NT2 and Sineretech. Donald has more than 36 peer reviewed publications and 22 issued patents.

We have assembled a strong and experienced device product development team, but currently lack the resources to scale our product manufacturing, internet and cloud information transport, and product distribution.  Once the prototype has completed testing and validation, we would seek to partner with both a larger diagnostic device company and internet service providers to establish product manufacturing capacity and product distribution network.  Despite initially reducing our profit margin, a partnership with a readily established diagnostic company and internet information providers will provide needed infrastructure to successfully bring our platform products onto market without delay.  Considering the companies invested in the Challenge competition, we believe that The Trinity Challenge will help provide the aforementioned key partnerships that we need to bring our product to market.

Two kinds of organizations we would like to partner with.  One is a large-scale device manufacturing organization such as BD or Abbott.  BD and Abbott already have COVID quick tests, piggyback on their manufacturing system is a quick way to move forward.  

Another partner is a digital information solution provider such as Google, Microsoft or eMed. We could consider dMed NAVICA platform.  Alternatively, we can work with Google or Microsoft to establish a platform dedicated for our solution.  We could also partner with 23andMe, 23andMe has established product distribution and information dissemination platform with customer base. 

Partnering relationship is open to discussion.  We will entertain any partnership arrangement that allows us to quickly move our solution forward worldwide.  We are willing to give up portion of our ownership in exchange to service provided.  We could also be under the wing of an established brand to gain positive branding experience.