Effective, Reagent-free Detection of the Odor Signature of Covid-19 Infection Using a Nano-Enabled Sensor Array

PROJECT SUMMARYCOVID-19 presents a public health emergency: There is a critical need for rapid, not reagent intensive, non-invasive testing technologies. This program will lead to the production of a prototype system to diagnoseCOVID-19 infection using the body odor signature of the disease. Our goal is to maximize societal impactby creating a validated prototype that can be used in a community or workplace setting by minimallytrained personnel for low-cost, on-the-spot diagnosis within minutes. The system will be developed in amanner that puts it on a pathway for rapid FDA approval. The Research Aims are:Aim 1. Optimization, assembly, and integration of a prototype system with the ability to odor signatureof COVID-19 in samples of body odor. The system will be simple to use, pose essentially zero risk to theoperator and the test subject, and report a result within minutes. The production cost at scale will beapproximately $9,000 for the complete measurement system, with a per test cost of approximately $0.50. Thedesign and construction of the prototype will be conducted by Novo Engineering, a leading firm with extensiveexperience in medical device development.Aim 2. Software development. Software for the system from VOC sampling to final diagnostic result will bedeveloped to ensure error-free operation of the device. Our preliminary results suggest that simple lineardiscriminant analysis (LDA) does an excellent job of classifying VOCs from human body odor as COVID-19positive or negative (92% sensitivity and 87% specificity). Optimization of the sensor array (Aim 1) and use ofricher feature sets in our classifier models will lead to further performance improvements in the prototype system.Aim 3. System Benchmarking and Validation. We will benchmark the full prototype system against a numberof VOC mixtures, with and without in vitro skin models. The system will undergo extensive testing against bodyodor samples from individuals with pathological conditions other than COVID-19 and other sources of potentiallyconfounding VOCs. The prototype will be validated against 1000 samples drawn from the COVID-SAFE programat Penn. The screening will include all members of the Penn community, and represents incredible racial andethnic diversity as well as a wide variance in age, sex, and gender.Aim 4. Regulatory Approval Plan The plan will be developed under the direction of Sr/Key personnel JohnFuson, JD, an attorney at Crowell & Moring LLP and a former Associate Chief Counsel at FDA. Novo Engineeringhas extensive experience in guiding prototype design in alignment with the requirements for FDA approval. Theproposed COVID-19 VOC-based testing device will be regulated by the FDA, likely as a Class I or II medicaldevice. Because there is no clear predicate device to reference in this case, we intend to submit a direct de novopetition to FDA asking the agency to categorize and clear the proposed COVID-19 testing device as Class I orClass II without reference to any predicate.