Eye On Business

Q. In which ways do you set yourselves apart from other central laboratories in the clinical space?

A. After the recent acquisition of Esoterix in May of 2005, LabCorp’s Clinical Trials division’s combined organization increased its scope of scientific expertise. We consider this the primary driver that differentiates us within the central lab industry.

Our broad scope of scientific expertise within the company is complimented by our centers of excellence (i.e. National Genetics Institute (NGI), Endocrine Sciences, Viromed, Colorado Coagulation, Dianon), that cover everything from complex cytometric assays to specialized genetic markers. These centers of excellence fuel our Clinical Trials organization to deliver cutting edge science to our biotechnology/pharmaceutical clients.

Q. How do your core competencies fare in a local as well as global marketplace?

A. Our core competencies are clinical laboratory testing, from the routine chemistry, hematology, microbiology to the very complex. The innovative esoteric testing covers both non-genetic and genetic testing in areas such as infectious disease, oncology, and molecular and biochemical genetics. Our vast esoteric testing menu includes flow cytometry, image analysis, immunohistochemistry, immunoassays, polymerase chain reaction (PCR), DNA sequencing, and cytogenetics.

Laboratory Corporation of America’s Holdings, as the parent company, allows for us to expand our centralized testing capabilities in a brand new facility for the US based headquarters for Clinical Trials. Over the past year we have increased our European facility as well. This renewed commitment also allows us to continue cultivating strong partners in the global market place such as India, China, and Latin America.

Q. With various GCP and GLP guidelines, how do LabCorp’s processes and analyses maintain themselves in such a heavily regulated environment?

A. LabCorp has a long history and a tremendous amount of experience operating within a regulated environment due to its involvement with plasma clotting factors under Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) through the work performed at NGI. We have gained similar experience through our government contracting work performed at Viromed under GLP and Good Tissue Practices.

This is the culture that the Clinical Trials Central Lab services developed within and the types of experiences that our process grew out of within our Quality Assurance Unit. This QAU is approximately 10% of our central laboratory staff within our global organization. The mastery of the culture to adhere to those regulatory requirements within our core processes makes the difference for success.

Q. You are known for your commitment to non-invasive diagnostic technologies, how does that impact the industry?

A. As technology improves in all areas of diagnostic medicine, both in-vitro and in-vivo, new processes will emerge that will allow doctors and scientists to garner more information without biopsies and surgical procedures. As an example, surrogate markers of disease states found in both blood and urine will have greater sensitivity and specificity. Improvements in imagining technology and better contrast media will begin to replace the domain typically occupied by current biopsies.

Q. What services have you implemented to streamline data transfer for your clients?

A. Currently we are working on increased web technologies for a proprietary system called CenterLinx Plus that will continue to streamline the data management of our studies and customer services. LabCorp’s recent appointment as Chief Information Officer (CIO), Scott Walton, has taken on innovative ways to approach new technologies and architecture that allow both the parent company and our Clinical Trials services to lead the way in data accessibility and information exchange.

Q. As new technologies emerge, how do you believe central labs will efficiently cover costs?

A. As new technologies emerge, any large central diagnostic laboratory can capitalize on the economy of scale within its business. We at LabCorp are well posed and historically experienced to implement any new technology we encounter into our normal operations.

Q. What factors do you believe will have the most impact on the clinical central lab industry in the near future?

A. Globalization and the management of the logistics surrounding those services are the key factor for the industry. We understand the central laboratory model and realize the need to have a strong solid presence in both the United States and within the European community. A command of the global services needed in the regions of Latin America, India and China, for example will ultimately need to be navigated as fluently as they are in the US and Europe. This can be accomplished with good quality testing, coordinated proficiencies, standardized methods, consistent platforms, and web based data management tools, which are all part of our overall strategy moving forward.