In an exclusive interview with The Fly, BioAffinity Technologies (BIAF) President and CEO Maria Zannes talked about the company, going public, its CyPath Lung test, upcoming events, and much more.
GOING PUBLIC: BioAffinity focuses on the development of noninvasive, early-stage cancer diagnosis, and targeted cancer treatment, and went public back in September. “The IPO itself required a tremendous effort. We had a very experienced team of professionals that were very dedicated to get us to that public status. I don’t have to tell people how difficult this market was but we had a very compelling story -- and we continue to have it, and we had a very successful IPO,” President and CEO Maria Zannes told The Fly.
“The funding and the going public was very important to us because the funds are the foundation to advance our strategic goals in commercializing CyPath Lung… The first step is very limited marketing to launch to insure we have the right branding, the right messaging, the most efficient methods in media that resonate with the family practitioners and pulmonologists that will order the test. The funds and going public also provide for development of diagnostics of other lung diseases,” the executive explained.
CYPATH LUNG TEST: The company's first product, CyPath Lung, diagnoses early-stage lung cancer -- the leading cause of cancer-related deaths -- with the potential to increase overall diagnostic accuracy of lung cancer, leading to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs. CyPath Lung is marketed as a Laboratory Developed Test by Precision Pathology Services in San Antonio, Texas.
“We will be looking at the U.S. first, but we have strong patent portfolio so we’ll also be considering the EU and China, and the rest of Asia… [CyPath Lung] is a test that is used after a physician and their patient receive a suspicious finding and used afterwards to determine what’s next. Because what’s next now are invasive procedures. Our text can step in and can offer a patient a very simple test, a very easy test to clarify what should be next: if they should wait or if a more aggressive follow-up is needed. We really see CyPath shifting, moving the paradigm on how screening can be done, and how people with high risk can be diagnosed and do it so at an early stage. We have completed a test validation trial, a clinical trial where we had very high sensitivity and specificity,” Zannes said.
COVID-RELATED IMPACT: Discussing COVID-related impacts with The Fly, Zannes said that the company had early delays but has since been back to normal. “We had delays at the beginning of COVID related to our clinical sites. We were in the midst of a clinical trial. That was the largest difficulty but we were able to continue to get research samples. Our labs also didn’t close. Our scientists were very careful in how we continued to work. We have been lucky because we had a significant amount of data to analyze and papers to write, allowing many of our scientists to work from home. We have now gone back to the new normal.”
WHAT’S NEXT: Looking out over the next year, BioAffinity expects to move into a national launch for CyPath Lung and open a clinical trial as it aims for approval by the Food and Drug Administration.
“We’re going to continue to work with our market launch and maybe next year move into a national launch. We will also be opening a clinical trial, a pivotal trial to go to the FDA for approval of this. We have a test that has been approved as a Laboratory Developed Test under the clinical laboratory improvement amendments that provides authority for the Center of Medicare and Medicaid to regulate laboratory developed tests. So, we will continue to offer it for the next couple of years. But we also intent to move forward with approval from the FDA and that provides us with broader marketing and claims potential. We’re also looking at the EU next, primarily the Netherlands. We also have good patent protection in China and the rest of Asia. So, this is a big market for us. That will be require a more cautious approach but it’s a very good market,” BioAffinity’s CEO told The Fly.
“We’re newly out. It’s a very exciting time for us because there’s a great focus on CyPath Lung but also great opportunity with COPD, asthma, and other lung diseases,” she added.
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. A more detailed version of some of the questions to follow.