Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2023 Earnings Call Transcript

Data from this study with PATH demonstrated the performance and ease of use of the COVID-19 tests on the new platform, which confirmed our belief in the potential effectiveness of the test in both at home and point-of-care settings. More recently, another third party initiated a study to evaluate the performance and usability of our new tuberculosis test. Both studies have been insightful and have substantiated the quality of our point-of-care PCR technology. And we are pleased to have additional evidence from third parties that supports the value and utility of our platform. With the clinical evaluations for the COVID-19 test now complete. We are currently on scheduled to submit our EUA for FDA review by the end of this year as previously projected.

In the meantime, clinical evaluations will continue in order to gather requisite data for future 510-K submission as well. We plan to introduce the Co-Dx PCR platform initially for COVID-19 detection, and later for other diseases. COVID-19 is a prevalent disease and it is believed by experts that will remain so as it moves toward an endemic stage. And we believe we have identified many environments where our platform represents a compelling solution for ongoing COVID-19 testing. Research and pre-market feedback indicates that high volume point-of-care settings like skilled nursing facilities should be diligently testing patients, visitors and employees to reduce the spread of respiratory infection, justifying the need for reliable point-of-care COVID-19 testing solutions.

Over time, we expect to also focus on other institutional settings where some of the most vulnerable patients reside, such as assisted living centers. This will be in addition to physicians’ offices, clinics, schools, and the at home setting. Ultimately, we believe that our COVID-19 tests will serve as the first in a series of indications That will open the diagnostics market opportunity for other tests on the Co-Dx PCR platform. Co-Diagnostics has been developing a menu of assays across several indications that we believe will bring significant value to patients and healthcare providers. As we discussed on our last earnings call, we are also developing a multiplex upper respiratory test with support from the NIH’s RADx Tech grant, which will test for flu A and B, COVID and RSV.

We believe this test will provide extensive value across many end markets, including those we initially planned to target with our COVID test. Another important goal for the near future is the development of the HPV test. HPV is one of the most common STIs in the world, and one of the greatest risk factors for cervical cancer, which is the fourth most common cancer in the world. More than 85% of the estimated 264,000 cervical cancer deaths each year are in low and middle income countries, all of which the World Health Organization or WHO believes can be dramatically reduced by access to diagnostics, vaccinations and cancer screenings. We believe that point-of-care testing for HPV could be a significant value to the HPV and STI testing markets and look forward to providing you with further updates on the role Co-Diagnostics can play in these efforts.

One of the most important initiatives for the company at this stage is the TB test for our new PCR platform. We believe that a significant opportunity exists for Co-Diagnostics within the global TB market. Given the speed and quality of our platform, as well as our Co-Primers technology. A lack of accessibility to TB testing is a global problem. And we believe the Co-Dx PCR platform will play a key role in the solution. This belief has been reinforced by the nearly $9 million of additional grant funding recently awarded to us by the Bill and Melinda Gates Foundation. This grant will be applied towards regulatory and clinical validation activities for our test, increasing manufacturing capacity and additional platforms software development. We anticipate beginning clinical evaluations for the TB test sometime within the first half of 2024.