An Interview with César M. García, President and CEO, IRIS International Inc

By Lori Sichtermann

IRIS International Inc provides in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing, and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical market.

Clinical Lab Products recently spoke with César García, president and CEO of the Chatsworth, Calif-based company, regarding the harmonization of the company’s three operational units and how they’ve come together to enhance the company and the clinical market.

CLP: Please give some background on the development of IRIS International Inc.
César García: IRIS International has been in business since 1979 operating as International Remote Imaging Systems. In November 2003, we changed our name to IRIS International to capitalize on the recognition of our IRIS brand and to signify a major change in our company philosophy. We needed a new image that matched the strides we’d taken over the course of 3 years to reinvent the company. As a result of these efforts, the company experienced significant growth in 2004. In the first 9 months of 2004, the company achieved a 49% revenue growth in comparison to the same period in 2003.

CLP: Please explain the relationship between IRIS International, IRIS Diagnostics, Advanced Digital Imaging Research (ADIR), and StatSpin.
García: IRIS International consists of three operating units. Our major unit, IRIS Diagnostics, designs, manufactures, and markets in-vitro diagnostics systems, consumables, and supplies for urinalysis testing. In 1996, IRIS International acquired StatSpin, which designs, manufactures, and markets small laboratory equipment and sample processing consumables for rapid specimen processing. Our ADIR subsidiary is our imaging research group based in Houston.

CLP: Are the previously mentioned companies complementary or separate in their focus and position in the clinical laboratory market?
García: In the past, these subsidiaries have operated more as separate companies. However, during the last 3 years, we have placed more emphasis on capitalizing on the synergistic opportunities of the group in research and development, marketing, business development, and manufacturing. For example, all units contributed significantly in the development of our flagship product the iQ™200 system, a fully integrated system that can perform a complete urinalysis, both urine chemistry, and microscopy at the push of a button. StatSpin and IRIS Diagnostics have shared operational management and technology development. ADIR provides some of the critical intellectual property in image analysis and pattern recognition used in the iQ200 automated particle recognition (APR™) software. Our technical core competencies are well-diversified, considering a company of our size. IRIS Diagnostics provides the core knowledge for in-vitro diagnostics, StatSpin specializes in specimen processing and handling, and ADIR specializes in image analysis. The diverse skills of these groups will prove to be invaluable as we develop integrated diagnostics solutions that capitalize on these core competencies. The future of our company depends on the continued development of new applications that provide increased clinical value.

CLP: What needs does IRIS International satisfy within the clinical laboratory market?
García: IRIS Diagnostics is the US market leader in automated urine microscopy. With our new iQ200 platform, we have made significant progress toward becoming the global leader in the utilization of image-based automated microscopy. Urine sediment analysis is a very important diagnostics tool, but its utilization has been limited. Previous technology platforms were either very labor-intensive, very expensive, or unable to provide high-resolution images to study the morphology of particles that have significant clinical information regarding the diagnosis of urinary tract infections, and kidney and bladder diseases. Our market positioning is that a complete urinalysis should include both modalities: urine chemistry and urine microscopy.

CLP: Describe some of the products the company provides.
García: Our company product portfolio includes a line of semi-automated urinalysis workstations, such as the original Yellow-Iris Model 500 and 939 series. In 2003, we added the fully automated iQ200 system, which combines urine chemistry and microscopy and their corresponding lines of consumable products.

IRIS Diagnostics has the most comprehensive support infrastructure solely dedicated to urinalysis and body fluids. We sell, service, and support directly all our US customers. We have become a global company with distribution in almost 50 countries, which are supported through our new distributor support centers in France and China.

StatSpin manufactures centrifuges with different models optimized for rapid blood separation, veterinary applications, and cytology. During 2004, StatSpin successfully launched two DNA processing workstations that automate the DNA denaturation and hybridization process for fluorescent in-situ hybridization (FISH) procedures.

Our future success depends on developing high-value applications and products such as the iQ200 system and the StatSpin ThermoBrite DNA processing station. We will continue to develop products that either improve clinical outcomes and/or reduce costs.

CLP: Does IRIS International have new products in development?
García: IRIS International continues to make significant investments in research and development with approximately 10% of revenues dedicated to new product development. We have already announced the release of three new products in 2005. IRIS Diagnostics will release the iQ200 Sprint™, a high-throughput urinalysis system addressing the needs of the clinical reference laboratory and other high-volume laboratories in hospitals and commercial institutions. This will be followed by the release of automated body fluids applications in all iQ200 systems.

Body fluid analysis is a very tedious procedure that consumes significant time, and it is very costly. Our automated imaging technique is particularly attractive, because it allows the medical technologists to confirm or, if necessary, modify the automated classification of cells in CSF, synovial, pleural, peritoneal, pericardial, and other body fluids. StatSpin will release a new centrifuge platform, Express 3, addressing the emerging need for processing larger tubes and more specimens in a STAT mode.

CLP: What challenges has IRIS International faced, and how has the company overcome these issues?
García: IRIS International’s major initiative in the last 2 years has been to become a global competitor in the field of urinalysis. That was a significant challenge for a company of our size, but it has been a highly rewarding investment. Today, the market is the world. Our expansion plans demanded a very comprehensive distribution network and very reliable products that can meet the diverse requirements of the global market place. We are pleased to report that both objectives have been achieved with the release of the iQ200 system. Our products are now sold in nearly 50 countries, and we have all the necessary registrations and international approvals to market these products. Our international distributors are truly partners, and they have made significant contributions to advance the adoption of our technology.

CLP: In what direction do you see the market heading?
García: I think that the trend will continue toward the consolidation of results in multipurpose instrument platforms. Automation will continue to be the dominant market requirement. IRIS Diagnostics has been very successful in combining urine chemistry and urine microscopy in a single automated platform that provides walk-away capabilities and consolidation of clinical information. This consolidation of results is very important, because it allows the technologist to interpret results in context. We will address this trend by developing new applications to advance the diagnosis of urine tract infection, bladder disease, and kidney disease. We must follow the chain of treatment and improve it, whenever possible.

CLP: Where do you see IRIS International in 5 years?
García: I see IRIS International developing advanced applications in urinalysis and specimen processing. We anticipate that there is going to be a convergence of technologies to develop these advanced applications. The company is uniquely positioned for this because of the diversified technology portfolio of our operating units, but it would be naïve to assume that we can do everything by ourselves. We will look into selective acquisitions, licensing, and collaborations with technology leaders as required to develop reliable and timely solutions to these emerging needs.

CLP: Any final words about IRIS International Inc?
García: IRIS International is in many ways a new company. We are determined to become the world leader in urinalysis and specimen processing. IRIS has been very successful this year due to the extraordinary accomplishments of our employees and other business partners. We count on them to deliver in our mission of enriching the quality of life for people everywhere.

Lori Sichtermann is associate editor of Clinical Lab Products.