Airway Infections Early Warning System

International commerce and travel connect world together in an unsurpassed speed and connectivity. The highly connected world spreads infectious diseases easily from one corner of the world to another, COVID-19 is a perfect example. To prevent spread of infectious diseases, early warning at local outbreak is essential for effective worldwide disease containment. There is currently lack of early warning system for infectious diseases. Infection control effort starts with sensitive detection and accurate identification of the pathogen. We propose to develop an airway pathogen detection and identification system detect pathogens from exhalation, the most common route of infection transmission. Easily accessible, inexpensive and user-friendly at home exhalation pathogen identification tests are linked to a privacy protected reporting system provide essential information for individual’s health management and for public health assessment. Worldwide application will create a public-accessible data base similar to Worldometer to alert public health officials and general public. 

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.  The unanticipated speed in Coronavirus outbreak 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 and services; unfortunately, the intertwined worldwide connectivity also leads to the spread of Coronavirus across the globe at an unsurpassed speed.  The 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.  Easily accessible and user-friendly pathogen identification tests linked to a privacy protected reporting system is needed for early warning.

Establish an early warning system for infectious agents at local level will help public health officials quickly manage alert report and implement containment procedures. Infection control effort starts with sensitive detection and accurate identification of pathogens.  Easily accessible and user-friendly pathogen identification tests linked to a privacy protected reporting system is needed for early warning.  We are introducing an Airway Infection Early Warning System (AIEWSTM).  The main component of the AIEWS is a wearable bioaerosol collection device with on device pathogen detection and identification capability. AerosolEaseTM, is a compact wearable bioaerosol collection device collects person’s respiration or breath.  The on-device pathogen identification system allows accurate and sensitive identification of 6 most common airway pathogens. At the completion of the test, the user is instructed to take a picture of the result shown on device with cellphone camera and send the picture via internet connection to our main computer for proper result interpretation.  The deciphered result is sent back to the user along with appropriate treatment recommendations if positive. The user information will not be identified without user consent; however, location of positive test result is to be registered for public health monitoring purposes.  

The ultimate objective of the project is for anyone in the world can use the AIEWSTM.  This is a non-profit project; we will keep the cost as low as possible.  The main objective is to make our product available on pharmacy shelves without the need of prescription. Through cellphone and a free App, data can be collected in real time and results can be returned to user soon after transmission. The sample collection and detection device AerolsolEaseTM can be purchased by general public or distributed through public entities or government. The product and service can be distributed through charity organization or government sponsorship for economically strapped or rural areas. We want to distribute our product and service at cost so to reach worldwide population without imposing significant economic hardship to individual users.  As we continue to refine our production process, we will strive to continue to reduce our cost and cost to our users.

One SOLVE challenge's objective is for a technology-based solutions that protect all people—especially those most underserved and at risk because of their race, ethnicity, age, gender, or income—from the impacts of disease outbreaks. Solve seeks solutions that strengthen disease surveillance, early warning predictive systems, and other data systems to detect, slow, or halt future disease outbreaks.  AIEWS is a technical solution directly monitors infectious agents output through breath or respiration for disease surveillance and early warning.  AIEWS aligns with SOLVE objectives and addresses the stated problem.  

We have done few preliminary experiments for the proof of concept.  Preliminary experiments indicated IETHD concept works for simultaneous detection of 3 pathogens, we want to extend to 6 most common pathogens.  We are in the process of design and produce prototype AerosolEaseTM by 3D printing process. 3D printed AerosolEaseTM units will be tested in the laboratory, product design will continue to refine and improve. Once arrived at a comfortable AerosolEaseTM design, we will produce about 1,000 units for beta testing. Beta tests will be performed locally for ease of obtain feedbacks. At our next stage, we will also initiate software and App development.  We will continue to add expertise into our organization as we grew. We believe Prototype Stage is the most appropriate.

The solution consists of combination of innovations. First, AerosolEaseTM as a wearable device for detecting airway pathogen from breath/respiration is a novel concept.  Although airway infectious pathogens have been demonstrated to be detected from aerosol, most tests were done in a laboratory setting with large instrument; our compact wearable device is a first. Volatile organic compound (VOC) based breath detection technologies are under development; but requires the use of sophisticated instrument with machine learning experience.  Second, IETHD core technology is innovative improvement of conventional ELISA to achieve much higher sensitivity required for early warning.  Third, testing breath or respiration is comfortable and less error-prone than swab-based tests; comfortable collection feature of our device will no doubt encourage wider use of our system which directly resulting in higher confidence on the statistically significant obtained data.  Fourth, cellphone data transport with data tabulation is another innovative feature to allow health care authority to identify and control infection.  Fifth, collected solution contain bio aerosol can be further analyzed to identify subtypes, variants and serotypes of identified pathogens.  Our test device will be available in drug store without prescription, which allow users to maintain privacy with individual’s free choice on the course of action. Resulting data can be accrued without invading personal privacy. A win-win situation for both users and authorities.

We are at prototype development stage; our solution is currently not serving any people yet.  We hope to launch the product in a year, at that point, we anticipate we can serve 10,000 to 100,000 people.  In five years, we hope our system can be used worldwide at all corners of the world.  The high occurrence of seasonal airway infection region can be identified early.  Information compiled in our database will allow us to predict seasonal infection trends and identify unusual airway pathogens.

The key impact indicator will be provided by beta test special interest group.  We will form a special interest group composed of general public with diverse background and age to test and evaluate our product and warning system. We will work with the special interest group to test our prototype and refine our prototype. The special interest group will also provide measure on our worldwide impact goal.

2 Full-Time.  1 Part-Time.  4 Contractors.

Donald Rao, Founder and CEO, HunchDx.  Tre Welch, VP Engineering and co-founder, HunchDx.  Theo deVos, VP product development and commercialization, HunchDx.  Noel Martinez, Director of Quality Assurance and Regulatory Affairs, HunchDx.  Xiuquan Luo, Director of Immunology Assays, HunchDx. Petro Starokadomskyy, Director of Molecular Biology, HunchDx. Ronald Plummer, senior engineer, HunchDx.  Jonathan Rao, Business Operations, Principles of R & Z Consulting Group.  Nancy Zhao, Financial Operations, Principles of R & Z Consulting Group.  The Realtime Group, product design, development, and validation contractor. GoEngineer, 3D printing contractor.  John Nemunaitis, Clinical Consultant, Gradalis, Inc. Edwin Flores, patent attorney, Chalker Flores LLP.

Our team composed of seasoned molecular biologists and engineers working in concert along with quality assurance, business management and legal experts on the team.  Donald Rao conceptualized the solution concept, Donald has more than 30 years of biotech industry experience in therapeutics and diagnostics.  Tre Welch is bioengineering faculty member at UTSW, owner of several device designs, leads the engineering effort and interphase with engineering design contractors and senior engineer Ron Plummer.  Theo deVos has more than 30 years of experience in diagnostics industry, Theo was involved in Epi proColon colorectal cancer screening from research to product development and approval. The solution team’s QA effort is led by Noel Martinez.  Noel has more than 25 years in managing QA operations in therapeutics and diagnostics industry.  Xiuquan Luo and Petro Starokadomskyy lead our R&D team in formulating and testing our solution formulations and designs.  Xiuquan and Petro are experienced biomedical researchers, together they have more than 40 years of postgraduate and industrial research experiences.  With COVID restrictions, the team meets regularly online to communicate work progress, inputs and needs.  Donald coordinates the R&D effort, manages the team needs, and working with business and legal.  As we grow, we will continue to attract the best talents with diversity, equity and inclusion.  

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.

Our team is highly technical in device development with knowhow in regulatory affairs and knowledge in bringing product to market.  We lack of fund raising capabilities, particularly the fund raising for non-profit organization and financial management specifically for non-profit organizations.  We also lack of software and data analysis expertise.  Our early warning system will heavily rely on the App to transmit data and to interface with users.  Software and App developer is needed to be partner with.  

MIT faculty could provide experienced software development team to develop App and programs for data handling, data compilation, AI and machine learning aspect of the project.  The partnership could be through grants and database sharing.  

Suitable manufacturing facility such as BD or Abbott Diagnostics could be partners.  Those partnership will be build on fee for service basis.

Our early warning device and system directly address the health and well-being of all people in US and the world without discrimination. Our goal directly fit in Robert Wood Johnson Foundation's funding objectives. 

Our early warning system will develop useful database for AI and machine learning.  AI and machine learning will help us predict trend of airway infection worldwide.  The AI for Humanity Prize will no doubt help to advance our solution.

Our solution strives for wide distribution of our product at health facilities worldwide.  We also plan to work to establish contract with local government and WHO to ensure product distribution globally. We will use the prize to help distribution of our products in health facilities around the world.