Kevin Clark, 58, is CEO of NOWDiagnostics of Springdale, which makes one-step diagnostic devices to detect pregnancies and illnesses. During the pandemic, the company created a test to detect COVID-19 antibodies, one of 126 products Clark has shepherded through the U.S Food & Drug Administration’s approval process.
Clark founded ImmunoVision in 1987 while he was pursuing his master’s degree and sold it to IVAX Corp. (now ERBA Diagnostics) in 1995. He graduated from the University of Arkansas with a degree in animal sciences.
What have you learned about the health care industry during your years as an entrepreneur?
It is changing, always changing, every day. And there is always going to be something new — from new technology to opportunities. It is quite difficult to remain focused on your plan and core technology because there are so many new things developing every day from around the world — so many ways you can use your knowledge and your influence to benefit health and health care. We at NOWDiagnostics are fortunate because our platform is designed to be flexible — designed to let us quickly adapt to our most urgent health needs like COVID-19.
When the pandemic hit, how was the company able to shift gears to focus on coronavirus tests?
The ADEXUSDx platform is revolutionary not only because it is entirely self-contained and does not require the addition of buffers and reagents, special treatment or refrigeration, or equipment or supplies.
It’s also revolutionary because of the structure and the 69-patented technologies built into the USB-sized device. The structure and the microfluidics allow for a highly flexible platform that can be modified to test for a huge number of viruses, diseases and conditions.
With our other clinical trials put on hold at the start of the pandemic, our team was able to quickly turn to focusing on using our adaptive platform for a COVID application. We started this process in March of 2020, and in May, only two months later, had submitted our [emergency use authorization] application to the FDA for authorization.
You are a veteran when it comes to going through the FDA approval process. What needs to be changed, if anything, to improve the process?
The speed and resources of the FDA, especially within their review process, simply put, takes too long. In fact, our ADEXUSDx COVID antibody test took a year less five days to get authorized — and that was under emergency authorization for a relatively un-invasive diagnostic.
If we truly want to drive innovation and shift the paradigm of health in this country, products need to move through the FDA quicker and with less ridiculous regulatory hurdles that don’t impact or ensure the safety and efficacy of products under their review.
How did you become interested in this line of work?
I fell into it face first, honestly. I thought I wanted to be a vet. But, at the University of Arkansas, I had a biochemistry teacher [Collis Geren] that was just phenomenal, and he became a mentor to me — helping me realize my interest in immunology and its intersection with biochemistry. While working on my master’s, I started my own diagnostics company to fulfill a need I saw, and the rest is history.
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