By Lori Sichtermann

Bob Mello

What’s in a name? For StatSpin Inc, the company’s name is testament to what it provides for the clinical laboratory market. The Norwood, Mass-based company was founded in 1984 around the idea of accelerating serum and plasma separation from whole blood. Today, the company manufactures products that enable clinicians to separate plasma from whole blood in less than 30 seconds.

The connotation of speed also applies to the company’s development. Over the course of 20 years, StatSpin has grown to become a leader in developing, manufacturing, and marketing innovative sample collection and processing devices, as well as instrumentation for clinical and animal health laboratories. The company is a member of the Iris International family, which includes Iris Diagnostics.

Clinical Lab Products recently spoke with Bob Mello, president of StatSpin, regarding the company’s position in the clinical diagnostic and research markets, and the importance of having a diversified and aggressive product line to accelerate future growth.

CLP: Where does StatSpin fit under the Iris International umbrella?

Bob Mello: StatSpin was privately held until 1996 when it was acquired by Iris International. Iris is a global leader in urinalysis and body fluids. Currently, StatSpin serves as the small instrument division of Iris International. The company markets products addressing the diverse needs of this market: from the low-volume user through the high-volume, fully automated user. On one extreme we have our flagship product, the iQ200 System, which is the first fully integrated, walk-away instrument performing both urine chemistry, and urine microscopy. On the low-volume segment, our CenSlide System, for semiautomated urine microscopy is a good fit for those laboratories doing less than 25 urine microscopics per day. Our cytocentrifuge, the CytoFuge 2, also is an excellent companion system for Iris body fluids application like the Model 500 with body fluids and the upcoming iQ200 body fluids module. The CytoFuge 2 prepares thin-layer slide preps for a wide range of body fluids, including fine-needle aspirates, cerebrospinal fluid, synovial fluids, and urine.

CLP: The company stresses its role in innovation. What recent products has StatSpin developed that have changed the way laboratory professionals perform tests?

Mello: StatSpin offers a wide range of sample-collection and sample-processing instruments and consumables for physician office laboratories, research facilities, teaching institutions, hospital laboratories, and veterinary clinics. We were the first to introduce a full line of plastic microhematocrit tubes in 1995, which addressed growing concerns about sharps in the laboratory. StatSpin also was the first company to offer a line of capillary blood collection devices with the anticoagulant in the draw tube—eliminating clotting problems and creating less trauma to the patient.

Our flagship Express 2, primary tube centrifuge is leading the way in rapid sample processing for cardiac and coagulation testing. The Express 2 provides plasma from whole blood in just 2 minutes. This is innovative in that the American Heart Association and the European Society of Clinical Cardiology recommends that the initial evaluation of patients with chest pain be performed within 20 minutes of their arrival in the emergency room.

Additionally, StatSpin always has focused on resolving customer issues as a means to diversification. Earlier this year we launched our first product in the area of sample processing for fluorescent in situ hybridization (FISH) procedure, a manually intensive and expensive procedure. FISH has become a mainstream technology for molecular pathology procedures performed in diagnostic laboratories and our core competencies in rapid sample processing and small laboratory instrumentation allow us to enter this growing market segment. Our ThermoBrite System® automates the denaturation and hybridization steps in slide-based FISH procedures, and provides walk-away convenience for clinical and research personnel.

We consider the area of FISH technology to be an attractive space. It’s a higher value of testing that consists of few competitors, therefore offering more market opportunity for a company like StatSpin. Additionally, we have secured an OEM partner for our ThermoBrite system that gave us an opportunity to expand our OEM business and participate more aggressively in this growing market.

The market for FISH technology is evolving, especially in genetic testing and tumor markers. A lot of new tests are being developed each day, but it is not as large as our standard blood separation or clinical centrifuge market. FISH has been around for many years, but it is continuing to find more mainstream applications each year. Now is an attractive time for us to get into this market.

CLP: StatSpin is well diversified in the clinical laboratory and veterinary markets. Why has the company diversified in such a way, and what have been the benefits of supplying the market with such a large variety of products.

Mello: Diversification is important, just like in an investment portfolio to hedge against different competitors and different trends in the market. The benefit StatSpin has is that we play in veterinary applications, which does not show signs of being affected by the country’s slow economy. Ironically, people tend to spend more on their pets than themselves. Even in a slow economy, the companion-animal health market that StatSpin has a large presence in is strong. That’s one of the benefits of diversification. Certain markets are affected in certain ways, and we’ve taken advantage of that in a positive way.

CLP: What advantages do StatSpin products have over competitors’ products?

Mello: Speed and reliability are our biggest advantages over our competitors. Because test turnaround is so crucial, it is important to reduce processing time wherever possible. This is an area where we excel, and we will continue to focus on this as we develop new products. Additionally our products are small, quiet, and reliable. We are proud of the quality and reliability of our product line, and we back this up with excellent service and a comprehensive warranty. We have a trained, dedicated staff of medical technologists who provide technical support to our customer base and distributor partners.

CLP: How does the company market its products?

Mello: We market exclusively through top-tier distributors. We do not have a direct sales force, and we do not sell our products through manufacture reps. All of our sales go through top-tier distributors in the different markets that we participate in worldwide. Overall, we have more than 75 distributors worldwide selling our StatSpin product line.

CLP: What are some of the challenges StatSpin faces and how does the company address them?

Mello: There are a number of growth opportunities in sample processing that we are pursuing. Some of these are in clinical diagnostics and others are in the animal health area. Like most small companies, we don’t have unlimited resources. However, we do have the financial backing and support of our parent, Iris International. We have recently expanded our research and development organization and are developing our strategic plan with Iris Diagnostics and our Advanced Digital Imaging group in Houston. Our challenge is to identify those technologies that are synergistic with our core competencies and to develop products using these technologies to meet our aggressive growth plan.

CLP: What is StatSpin’s outlook for the future?

Mello: We will continue to be the leader in rapid sample processing for clinical and veterinary applications. We will strengthen our position in sample processing for stat testing while expanding our product offering in the area of specimen handling and processing in molecular diagnostics and other high-value procedures. We also plan to leverage our position with Iris International for key products, financial resources, and global distribution. We will remain focused on our core competencies of sample collection and sample processing while looking for new innovative approaches to solve common laboratory sample-processing problems.

CLP: How would you sum up StatSpin’s offerings?

Mello: We offer a wide range of sample-collection and sample-processing devices and instruments. We are known as a rapid sample processing company, and we have a reputation for excellent customer service and support. But, we want readers to realize that we are not focused solely on the US clinical marketplace. We are a global company that is part of a much bigger entity, and we have more resources than most companies our size. Moreover, our research, development, and manufacturing capabilities allow us to further benefit our customers.

Lori Sichtermann is associate editor of Clinical Lab Products.