CEO SUMMARY: As new diagnostic technologies move through the development pipeline and into widespread clinical use, the scientific knowledge and skill sets needed by laboratory staff and management will change. The emphasis in laboratory medicine will evolve to include more molecular technology, but this evolution will proceed incrementally, giving all laboratories time to adapt.
RAPID ADVANCES in genomics and proteomics promise to revolutionize healthcare and the laboratory testing industry. But it will be a few more years before truly disruptive technology becomes a reality.
That was the consensus of three experts who participated in a strategic planning session with the Board of Directors of the American Society of Clinical Pathology (ASCP). The session took place last month in New Orleans at the ASCP’s annual meeting.
The three experts included Myla Lai-Goldman, M.D., Executive Vice President and Chief Medical Officer of Laboratory Corporation of America, Tim Orr, Vice President, United States Marketing for Johnson & Johnson’s Ortho-Clinical Diagnostics (OCD) and Robert L. Michel, Editor-In-Chief of THE DARK REPORT.
There was surprising consensus among the expert panel on at least three key points. First, there is no “disruptive technology” in the pipeline which would create rapid and far-reaching changes in the clinical laboratory industry. Most technologies currently in development will take about five to eight years to enter the marketplace and gain widespread acceptance and use.
Second, the knowledge base for laboratory medicine is going to steadily shift toward the fields of genetics and proteomics. This will happen gradually, not suddenly.
More Complexity Ahead
Third, more complexity is coming to the management of clinical laboratories, in several ways. As new assays are approved for clinical use, these assays will require more sophisticated skills and equipment in the laboratory. The organization of the laboratory itself will undergo change, with testing migrating out from the core lab into point-of-care, near-patient, and patient self-test settings. As well, management philosophies and techniques used in the laboratory will become more sophisticated.
Each expert panelist has a unique perspective on the laboratory market-place and emerging technology. For that reason, the convergence of views on these three points is noteworthy.
Lai-Goldman, as LabCorp’s Chief Medical Officer, is uniquely positioned to see the wide range of diagnostic technology that is under development. A large number of biotech and pharmaceutical companies regularly approach LabCorp to demonstrate emerging technologies. They want LabCorp’s perspective on whether the healthcare marketplace would accept these technologies. In addition, LabCorp has its own research and development effort under way. It is continually looking for promising technology which it could commercialize.
Early Look At Technology
In a similar way, Ortho-Clinical Diagnostics also gets to see promising new diagnostic technology as it undergoes development and evaluation. As one of the world’s largest diagnostic manufacturers, OCD is motivated to actively seek out and acquire promising technologies. For this reason, Orr is privy to a wide range of emerging diagnostic technologies.
For laboratory directors and pathologists interested
in the strategic direction of the laboratory industry in the near future, this panel of experts had reassuring news.
The perspective of Michel complements that of the large commercial laboratory and the large diagnostic manufacturer. As Editor-In-Chief of THE DARK REPORT, he constantly visits laboratories and industry vendors. He closely watches the point of intersection where new diagnostic technology first enters the clinical marketplace.
For laboratory directors and pathologists interested in the strategic direction of the laboratory industry in the near future, this panel of experts had reassuring news. During the next few years, it is expected that diagnostic technologies currently under development will take between five and eight years to enter the marketplace and gain widespread acceptance.
The example of liquid preparation Pap smear tests illustrates this dynamic. In 1998, this technology was just entering the marketplace. It took five years for liquid prep Pap tests to capture a market share which is now considered to be more than 65% of the 55 million Pap tests done annually in the United States. It was the opinion of all three panelists that this example would be representative of the clinical acceptance curve for most new diagnostic technologies currently in the development pipeline.
Consensus around the second key point, the shift toward greater use of genetic and proteomic science in laboratory medicine, reinforces the experience of individual laboratories. At LabCorp’s Center for Molecular Biology and Pathology in Research Triangle Park, North Carolina, that future has already arrived. This laboratory is home to the most advanced and complex testing done inside LabCorp.
Lai-Goldman told the ASCP board that MTs hired to work in this laboratory generally must undergo several weeks of additional classroom training before they are ready to work at the bench. This training emphasizes the molecular science that supports the sophisticated esoteric assays performed at that site. She recommended that MT training programs should evolve to provide more training in these new areas of diagnostic testing. This is the knowledge that will be required to support most of new diagnostic assays expected to enter the clinical marketplace during the next five years.
For the ASCP, one message was unmistakable. Training programs for medical technologists (MT) and medical laboratory technicians (MLT) must be revised to accommodate this gradual shift in the laboratory testing menu. Molecular science will play a greater role as routine chemistry and hematology testing receives less emphasis and molecular assays gain greater clinical importance.
More Complexity Ahead
The trend toward more complexity in laboratories reflects fundamental changes within healthcare and the economy in general. Consumers increasingly want healthcare customized to their specific needs and particular medical conditions.
At the same time, medical science is gaining the ability to discern the differences between individuals. These differences explain why some people get disease and others do not; why a specific disease is more virulent in some people and not in others; and why some people benefit from therapeutic drugs and others do not.
For laboratories, the complexity trend will play out in three dimensions. First, treatment algorithms for disease will become more complex. As science enables clinicians to understand more about disease processes, diagnosis and therapy will become more detailed and specific. Laboratories will need to respond to the more sophisticated demands of clinicians in this area. Advances in diagnosing and treating different types of breast cancer illustrate this principle.
Second, advances in molecular diagnostics will add to the complexity of performing laboratory tests. In simple terms, a routine chemistry test panel is much less complicated to perform than a test to identify genetic mutations present in an HIV patient. The technical knowledge required by the laboratory staff to support such testing will be more detailed and intricate.
Third, the organization and operation of clinical laboratories will be- come more complex, in at least three dimensions. In the first dimension, laboratory testing will be migrating out from the core laboratory. New standards for patient safety and higher quality care are already pulling testing into settings like the hospital emergency department. Consequently, laboratories will end up managing diagnostic testing being performed in a variety of locations within the healthcare system.
In the second dimension, increased medical specialization will generate specialized diagnostics to support it. Laboratories now organized around traditional departments will need to develop subspecialty expertise and support the diagnostic needs of these subspecialties. The organization chart for the laboratory will become more complicated.
In the third dimension, management of laboratories will evolve toward more sophisticated management systems and methods. The earliest successes of laboratories adopting ISO-9000, Six Sigma, and Lean management systems provide evidence of this trend. Management of laboratory operations will require more complex and subtle skills.
In conclusion, the three key insights suggest that change within the laboratory profession will be incremental, not disruptive. This gives lab directors and pathologists needed time to respond appropriately to the steadily-evolving