Lewis Lopez, MD

In 1990, Lewis Lopez, MD, was working for BioStar Medical Products when the company was divested of its autoimmune and ELISA technology. Lopez snapped up the technology and bought Reaads Medical Products in Boulder, Colo. In 1998, the company went public and changed its name to Corgenix, meaning heart development, which embodies the company’s central focus on new cardiovascular products. CLP spoke with Douglass Simpson, Corgenix’ president and CEO, about the company’s history and future.

Q: Was there a guiding purpose?

A: Toward the end of the BioStar years in the late 1980s, Lopez was developing new products to measure anti-phospholipid antibodies, which at that time were still very much in the research phase. New anti-phospholipid antibodies were being discovered, and the direction of the new company was to build on this whole new area—markers integral to the treatment of patients with autoimmune diseases—lupus and rheumatoid arthritis. Beginning in the 1990s, we discovered that anti-phospholipid antibodies had the ability to diagnose and assess patients’ conditions in a much broader population than just autoimmune patients. We found high levels of these antibodies in all sorts of patients with cardiovascular disease. As anti-phospholipid testing was becoming a common technology widely accepted by physicians globally, Reaads was the first company to incorporate that information and technology into a line of commercially available products for global distribution. The products became available to all laboratories and all physicians, which led to more clinical studies, more interest. We were the first company to begin putting some level of standardization in this area.

Q: Where did you fit into the picture?

A: I joined the company in 1993. My educational background is in biology and chemistry; I have bachelor’s and master’s degrees with graduate work in parasitology. While the parasitology is not really related to the diagnostics business per se, I joined this industry with a solid understanding of basic biological processes, a foundation that every effective CEO in the IVD industry must have. I also spent 2 years doing product development in my first job in a diagnostic company, a stint that made me appreciate the complexities this business requires. That enabled me to affect decisions based on technology.

Q: How do you stay nimble across the globe?

A: Our headquarters and primary facility are located in suburban Denver. Here, we are responsible for product development, manufacturing, and regulatory compliance, as well as sales and marketing for North America. We also have an office in the UK responsible for sales and marketing for the rest of the world. We started that subsidiary because we wanted to operate as a global company; we did not want to be looked at just as an American company that happens to sell in Europe. In the US and the UK we sell direct, and in the rest of world we work primarily through independent distributors. Even for a small company, the two operating sites are key to much of our recent successes and growth. Our average annual growth over the last 10 years is about 15%.

Q: What are your chief products?

A: We are emerging as a cardiovascular disease company. We expanded our anti-phospholipid product line in the mid 1990s by adding tests for important clotting markers—Protein S, Protein C, von Willebrand Factor—used by physicians to assess the reason for patient clotting or bleeding disorders, and potentially contributing to a patient developing a cardiac event. All of our products are on the same ELISA microplate platform, providing us significant economies in our manufacturing processes.

Q: Any outlier products?

A: We do have one rather maverick product that does not fit into the cardiovascular strategy; it measures the polysaccharide hyaluronic acid, which data suggests can be used to determine the degree of fibrosis of the liver, mainly in Hepatitis C patients. In 1993, Chugai Pharmaceutical Co Ltd, a Japanese company now part of Roche Pharmaceuticals, contracted with us to develop a next-generation hyaluronic acid product. Corgenix developed the product on our platform with our technology and manufactured it for them to sell in Japan. Years later, we secured the rights for marketing the product, and we sell it worldwide today.

Our new AspirinWorks product was cleared by the FDA in May 2007. AspirinWorks is an ELISA product that measures a urinary metabolite—11-dehydro thromboxane B2—the target of aspirin therapy. Aspirin blocks an enzyme on platelets and reduces their stickiness. About 75% to 80% of individuals taking aspirin see a significant reduction of clumping of platelets and a reduced risk of having a heart attack. The AspirinWorks test can tell you if aspirin is having an effect on an individual’s platelets. By December of this year, we expect the test to be available in virtually every geographical region.

Q: Describe the evolution of your product lines.

A: While our primary focus remains cardiovascular disease, we do have an exciting program working on viral hemorrhagic fevers. In 2005, we entered into a collaboration with the US Army, Tulane University, and a couple of small biotech companies to develop products to detect Lassa virus, a cause of hemorrhagic fever, which is endemic in sub-Saharan Africa. This virus is not only deadly and seldom tested for in Africa, but it is also an ideal potential bioterrorism agent. Through this collaboration we have developed the first of several products that can eventually be run in conventional laboratories to rapidly identify the virus. These products will be used for biothreat purposes in the US, Europe, and Asia, and also for important clinical purposes in Africa. The initial work has been done under a 3-year grant from the NIH—$3.8 million for the five entities involved. We expect that we will develop additional similar products in this area, including tests for other hemorrhagic fevers, Ebola virus, and others.

Q: Which products are planned for the future?

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A: Over the next few years, we expect to expand our focus on the whole area of aspirin effect metabolites. Aspirin has a lot of other indications for use in the body besides helping headache and reducing one’s risk of cardiovascular disease. There is a lot of interesting clinical research regarding aspirin therapy for individuals with cancer, for example. I think we will see many applications of our AspirinWorks product as more of these studies are published. Also, we want to expand our virus program beyond just Lassa fever. We know there are a lot of other infectious agents in Africa and South America which have a real clinical need, but also pose a great risk of biothreat, all which we believe are not being properly addressed. We also have ongoing cardiovascular marker programs; one of them is a spin-off of the phospholipid antibodies/antigens with Japanese collaborators.

Q: What is your outstanding accomplishment?

A: Most recently, we took a very complicated marker—the 11-dehydro thromboxane for our AspirinWorks product—and moved it through development, the regulatory process, and to the market in a relatively short period of time. It took about 3 years from concept to FDA clearance.

Q: Describe the company’s future.

A: In the next 2 to 3 years you should see a significantly larger company, primarily because of the AspirinWorks contribution. Our participation in this whole virus arena will increase with perhaps a full line of products in the market and a significantly bigger presence in Third World areas. And as we learn more about aspirin’s effect on cancer and other diseases, you’ll see Corgenix products playing important roles in those markets as well.

Judy O’Rourke is associate editor of CLP.