An Interview With Duane M. Steele, COO

Diamedix knows clinical diagnostics. The company was established in 1986 after acquiring Cordis Laboratories. A year later, it was acquired by IVAX Corp and was operated as a wholly owned subsidiary until 1996. At that time, Diamedix was incorporated into IVAX Diagnostics along with two other affiliated companies. In 2001, IVAX Diagnostics became a public company and now trades on the American Stock Exchange under the symbol IVD. Diamedix continues to operate as a subsidiary of IVAX Diagnostics along with its two affiliated companies: Delta Biologicals Srl. and ImmunoVision Inc. CLP spoke to Duane M. Steele, Diamedix’s COO, regarding the future of the industry and how Diamedix plans to operate.

CLP: What is your professional background?

Steele: I have been in the diagnostics industry virtually my entire professional career. I graduated from the University of Minnesota, and my first job was a marketing position with Kallestad Laboratories. I initially worked for Kallestad at its Minneapolis-area headquarters and later moved to the San Francisco area as a sales representative. After 5 years, I moved back to Minnesota and had responsibility for all of its international operations and helped establish subsidiaries in Canada, Germany, Switzerland, and Australia. Over the 15 years that I was with Kallestad, I relocated to Austin, Tex, and held a variety of positions, including senior vice president, with responsibilities in sales, marketing, manufacturing, and R&D. After Kallestad, I was general manager of Austin Biological Laboratories and later moved to the Miami area to join Diamedix. I have been at Diamedix for more than 11 years, where I am the chief operating officer. I also hold the position of vice president–business development with IVAX Diagnostics, the parent company of Diamedix.

CLP: How and why did you decide to go into the clinical diagnostics business?

Steele: Diamedix has been involved in diagnostics since it was established in 1986. We have a long history of being a quality manufacturer of ELISA test kits, focusing primarily on the areas of testing for autoimmune disorders, such as rheumatoid arthritis and SLE, and infectious diseases, such as measles, mumps, and infectious mononucleosis.

CLP: What needs does the company satisfy within the clinical laboratory market?

Steele: Along with a wide array of test kits, Diamedix is now very active in providing the clinical laboratories that we serve with an automation solution for ELISA-based testing. We have been able to combine the proprietary Mago® Plus automated enzyme immunoassay analyzer instrumentation manufactured by our sister company in Italy (Delta Biologicals) with the ELISA test kits that Diamedix manufactures here in Miami, and we offer an automated systems approach for our customers. The Mago Plus System offered moderate complexity automated ELISA testing to all laboratories for the first time.

CLP: How has the recent merger of your parent companies affected the company’s development?

Steele: In January of this year, IVAX Corp merged with Israel-based Teva Pharmaceutical Industries Ltd in a $7.4 billion deal that created the largest generic pharmaceutical company in the world. As part of this transaction, the 72% ownership that IVAX Corp held in IVAX Diagnostics was transferred to Teva. Although IVAX Diagnostics continues to operate as a public company, Teva is the major shareholder and Diamedix continues to operate as a wholly owned subsidiary of IVAX Diagnostics within this new structure.

CLP: What is your flagship product? How do you see this product or later versions of the product developing?

Steele: Currently, our flagship product is our whole line of immunosimplicity® ELISA test kits. With more than 20 years of ELISA experience, our customers find that our test kits are among the most sensitive and specific on the market, and we enjoy a healthy share of the ELISA testing market.

In the future, we expect our new Parsec® System to become our flagship product. This new proprietary automation system was designed and is being manufactured by our sister company in Italy. It is a modular and scalable system that has been designed to meet the testing needs of laboratories of many sizes. Initially, this innovative new system will automate ELISA assays, but it is our intent to add more technologies in the future, such as chemiluminescence and IFA. The Parsec System has been released in Europe, but we are waiting for FDA 510(k) clearance before launching it in the United States.

CLP: What sets your products apart from similar products on the market? 

Steele: Attention to detail. Our immunosimplicity test kits are validated and cleared for use on the Mago Plus. That was a big undertaking, but it saves a lot of method-verification time for the laboratory. When performed on the Mago, the test kits have a moderate complexity, allowing ELISA testing to leave the high-complexity laboratory and establish itself in the moderate-complexity laboratory. With our Mago Plus, we process ELISA plates by monitoring each strip, instead of the whole plate. It is a small detail, but in a time-dependent assay, it is one that allows the entire plate to be processed in a more efficient manner.

CLP: What are some of the challenges clinical labs face today? How have you helped them deal with these challenges?

Steele: Our customers are constantly trying to figure out how to do more with less. The number of assays and the overall testing volume has continued to increase, but laboratories are under intense pressure to improve efficiencies. All of our instrumentation systems are designed to improve the efficiency and throughput of our customers and assist them in allowing their laboratories to become more productive.

CLP: What has been your company’s greatest contribution to the industry?

Steele: Diamedix’s greatest contribution to our industry has been both quality test kits and the new level of automation that we have brought to those laboratories performing ELISA-based autoimmune and infectious-disease assays.

CLP: What are a few challenges your company has faced in the past? How have you overcome them?

Steele: Some of our biggest challenges have been in the area of scaling up our manufacturing capacity to meet our increased needs over the past several years. We have greatly increased our reagent lot sizes, and we continue to implement additional automation in our reagent-manufacturing process.

CLP: What trends do you see impacting the clinical lab industry? How is your company adapting and responding to these trends? What challenges do you expect to face in the future?

Steele: The number of experienced laboratorians expected to retire in the next few years is staggering. We expect that most of the specialized procedures, such as reading IFA slides and performing manual ELISA testing, will begin to be replaced by more automated processes.

Automation and consolidation have been key factors influencing our industry. We have taken a very progressive approach to creating a public company that gives us a great deal of vertical integration and flexibility. By including the synergies derived from using antigens manufactured by our sister company in Arkansas (ImmunoVision), coupled with proprietary instrumentation from our affiliate in Italy (Delta Biologicals), we have been able to create a systems-based approach to provided automation to our customers. Consolidation of both laboratories and vendors in our industry continues to raise the bar of laboratory expectations. We believe we are strategically well-positioned to continue to grow in the diagnostics industry.

CLP: How will you remain competitive in the future? What products and/or services do you plan to offer in the near future?

Steele: Our new automation system is expected to give us a very exciting high-volume platform from which to develop additional ELISA-based assays as well as products using different technologies. And with the current Mago Plus System, we are positioned to provide an automation solution to virtually any size of laboratory. We expect to expand our product menu both through organic growth and through select strategic alliances. 

CLP: What would you like CLP readers to learn about Diamedix?  

Steele: When compared to the giants in the industry, we are a very small company, But we have employed many of the best and are striving to match the giants in the quality of products and services delivered.

Michelle Said is associate editor of Clinical Lab Products.