Dr. Maria Nagy Talks At-Home Antigen Tests for COVID-19

While working on my Ph.D., I read a journal article one day and immediately realized a new way to identify bacteria that was significantly cheaper, faster and easier than the standard culture method (which takes 3 days). I knew exactly what to do scientifically, but I did not know that a mere mortal could start a biotech company. I always said as soon as I find a “big” company developing my method, then I would go join that company. Fast forward 7 years and there was no “big” company working on my method. Then I was inspired by a speaker at a conference that I attended who spoke of how he built his own biotech company. Finally, it dawned on me, that I could start my own company, and we could build it ourselves. Hence, Quorum X Diagnostics was born.

We will use the funds to optimize the prototype, manufacturing, clinicals and FDA’s Emergency Use Authorization.

We will be applying for something called Emergency Use Authorization (EUA). So, the tests and data are reviewed by the FDA, but the review process is not as vigorous as the FDA 510K process which can take several months. EUA can be as fast as 2 weeks.

The test you see at the doctor’s office or the drive-thru locations are primarily PCR-based tests. In order to complete a PCR-based test, you need a piece of equipment the size of a small microwave, a CLIA certified laboratory, and a highly technical staff. Our test is a simple lateral flow test, kinda like a pregnancy test, but for COVID. So, the user will swab their own nose, put the sample in a reagent tube, squish it a couple of times, and then drip onto the test kit. After 15 min you will see 1 line or 2. The process is quite simple. We will also have a phone app that will provide an instruction video, and the user will take a picture of the result and the app program will help the user interpret the results if they are unsure. This app will also provide the option of connecting directly to a telemedicine service for further assistance based on the test results.

We have a working prototype for the QXD-1 Fast Test for Pseudomonal Pneumonia. We halted working on this product when COVID hit to focus on the bigger problem. But we also have designs for several other rapid tests including a Mutliplex Test for pneumonia, Bronchitis, UTI, yeast infection and bacterial vaginosis. These would all be based on our unique proprietary technology.

Most simply put, an antigen is a compound or protein that is produced by a virus or bacteria that triggers an immune response. Essentially, we are screening for a protein that is located on the outside of the virus. These viruses are covered with this protein. If the virus is there, the protein is there. The antigen test will allow us to know if you are in the middle of an active infection or if you are asymptomatic but shedding the virus.

Just like with all businesses there is the possibility of risk. There can be risks around the stability of the antibodies during high yield manufacturing. Or if we cannot achieve optimum sensitivity and specificity with our first choice antibodies. If either of these occurs we will shop other manufacturers until we find the right fit. 

There can [also] be risks around having individuals complete the test themselves that there is variation in results from person to person. To offset that we provide detailed instructions, a user’s video, and access to support. 

I have a Ph.D. with 14 years of experience in academia and the biotech industry with an emphasis on bacterial resistance and bacterial communication. 

Next is Dr. Angel Rivera (CTO), an MD/Ph.D. with 25+ years experience. He has authored 80 peer-reviewed papers. Additionally, we have a very active team of 5 advisors all either MD, PhD or MBA. In this regard, we have: 

• Dr. Rodney Nash, Ph.D.-(CEO) of Jeevan Bioscience, (CSO) of Omni and on the Board of 5 hospitals;
• Dr. Adam Bressler, M.D.-Director of Infectious Disease at Emory Hospital (fka Dekalb Hospital); 
• Dr. Navdeep Jhita, M.D. NIH Post-Doctoral Fellow in Cancer Immunology and Vaccines, Department of Pediatrics, Division of Immunology, The Lowrance Center, Emory University; 
• Mr. Azad Ur Rahman-10 years Former Deloitte Manager, Supply Chain Expert; 
• And Mr. Eric Woods, an experienced researcher in materials science, chemistry and biology plus a former patent examiner.

Our business model is twofold: First, it is direct-to-consumer sales and secondly, we have a strong working relationship with a popular telemedicine service, Physicians 360. They are located in 50 states with drug store kiosks already in place. We are looking to partner with them for the fast dissemination of these tests into people’s hands.

My vision is to develop a line of products based on our proprietary technology and build out the scientific infrastructure of the company. Once that’s achieved if there is a larger company that can take the vision further than we can due to distribution opportunities, that would be the time to exit.