News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Upcoming Executive War College conference features experts on molecular and genetic testing

Explosive rates of growth in clinical use of molecular diagnostics assays seen in recent years are about to be matched by a new opportunity for medical laboratory testing. Experts predict the coming “big thing” in clinical laboratory and anatomic pathology will be next-generation gene sequencing (NGS).

This should be welcome news for financially-beleaguered pathology groups and clinical lab organizations. Lab tests that incorporate next-generation gene sequencing technologies are expected to offer clinicians greater value by making it possible to more accurately detect and characterize disease at earlier stages. For this reason, these lab tests are expected to be adequately reimbursed by most government and private payers.

Opportunities for Anatomic Pathology Groups

However, the opportunities for anatomic pathology groups to set up and offer useful clinical assays that incorporate next-gen gene sequencing technologies may go unrecognized by many pathologists who are the business leaders of their pathology group practice. That is understandable, since the business leader of these pathology groups spend the majority of their time reading cases and providing professional services. Much less time is spent on the business strategies and management tasks required for the smooth daily operation of the pathology group practice.

The story is similar for hospital and health system laboratories. Lab administrators—themselves unfamiliar with the rapid developments in gene sequencing—can easily overlook the most auspicious time to introduce useful next-gen gene sequencing tests to the client physicians in their communities. That allows competing labs to grab market share and build their reputations with referring physicians as lab innovators.

“The rapid uptake of molecular diagnostics by physicians is one of laboratory medicine’s best success stories over the past decade,” observed Frederick L. Kiechle, M.D., Ph.D., Medical Director, Medical Director, Clinical Pathology, Pathology Consultants of South Broward, LLP. “For example, infectious disease testing has been transformed by a host of molecular-based clinical lab tests.

Next Gen Gene Sequencing by

Opportunities for clinical labs and pathology groups to use next-generation gene sequencing technologies will be presented on May 3, 2012, in New Orleans at the special conference titled “Molecular Diagnostics and Next-Generation Gene Sequencing” at the 17th Annual Executive War College. (graphic copyright

“Oncology is another medical specialty where an expanding menu of molecular assays and genetic tests gives physicians effective new tools,” he continued. “In both these specialties, clinical labs and pathology groups that were first in their community to introduce useful molecular diagnostic assays built strong relationships with referring physicians. This was revenue-positive for the labs, because the steady increase in specimen volume for these molecular tests.”

As most pathologists and clinical laboratory manager know, molecular diagnostics have grown at double-digit rates for more than 15 years. It is predicted that physicians will similarly accept and use medical laboratory tests built upon next-generation gene sequencing technologies. In turn, this will fuel double-digit growth for these types of lab tests.

There are expectations that more use of next-generation gene sequencing in clinical diagnostics will contribute to this rapid increase in medical laboratory test utilization. In fact, this month, Clinical Lab News, a monthly publication of the American Association for Clinical Chemistry made next-gen gene sequencing its front page story.

The Power and Promise of Next-Generation Sequencing: Will Whole Genome Sequencing Become the Gold Standard?” laid out the case as to why next-gen gene sequencing may be poised to replace Sanger sequencing as the scientific gold standard, but only after a host of technological and regulatory issues are resolved.

This story did have a recommendation for pathologists and clinical laboratory administrators, affirmed by two different laboratory medicine professionals. “I don’t think anybody should be on the sidelines waiting,” observed Michael Metzker, Ph.D., Associate Professor of Molecular and Human Genetics at Baylor College of Medicine and Assistant Director of Future Technologies at Baylor’s Human Genome Sequencing Center in Houston, Texas.

“The field is moving very quickly and there are many of opportunities for discovery and great science,” said Metzker to the Clin Lab News Reporter. “But one also has to be cautious. One way to do that is through partnerships with groups already experienced with next-generation sequencing. That’s a great way of getting your feet wet without being completely isolated and trying to figure out things others already have figured out.”

In a similar fashion, Clin Lab News wrote that Karl Voelkerding, M.D., “urged [clinical] laboratorians to learn as much about NGS as possible.” Voelkerding is Medical Director for Genomics and Bioinformatics at ARUP Laboratories and Professor of Pathology at the University of Utah in Salt Lake City.

“Even if a [clinical] lab isn’t going to be adopting this technology immediately, the director of that lab can be in a situation wherein he or she triages requests for diagnostic analyses,” continued Voelkerding. “So it’s important for lab directors nation-wide to begin a self-education process. Since this is all new technology and new data analysis, there are no textbooks one can refer to. It’s a self-education process with a steep learning curve that requires reading reviews and attending educational workshops in this area.”

Pathologists Can Learn about Molecular and Next-Gen Sequencing

Lab administrators and pathologists interested in keeping their labs at the front edge of clinical services will be interested in a special conference on Molecular Diagnostics and Next-Generation Gene Sequencing. This conference will take place on Thursday, May 3, 2102, in New Orleans, Louisiana, immediately following the conclusion of the 17th Annual Executive War College on Lab and Pathology Management on May 1-2.

Presentations will cover the essential topics needed for any laboratory to establish and operate a clinically-effective and financially-sustainable molecular diagnostics test service. The comprehensive curriculum addresses your lab’s needs in:

  • understanding the science of these assays;
  • mastering federal and state regulatory requirements;
  • anticipating how and why Medicare and private payers are tightening coverage requirements and moving toward pre-authorization of expensive molecular and genetic tests;
  • creating the right information technology and lab informatics capabilities to offer molecular and genetic tests; and,
  • learn about next-generation gene sequencing technologies and how they will be incorporated into clinical diagnostics.

Take the time right now to visit the Executive War College website and check out the experts and topic who will be speaking on May 3 about molecular diagnostics and next-gen sequencing. Then reserve your place to be with us on at the New Orleans Sheraton Hotel for the single-most valuable educational investment you’ll make this year.

Four Easy Ways to Register for Executive War College 2012:

  1. Register ONLINE
  2. Call 512-264-7103. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
  3. Fax this complete registration form to 512-264-0969
  4. Mail the one page formwith payment to:THE DARK REPORT21806 Briarcliff Dr.

    Spicewood, TX 78669


Related Information:

The Power and Promise of Next-Generation Sequencing: Will Whole Genome Sequencing Become the Gold Standard?

The Future of Epidemiology: Next-Gen Sequencing

Frost & Sullivan Report Identifies Molecular Diagnostics as Fastest-Growing Sector of Clinical Pathology Laboratory Testing

Palmetto, Medicare’s Biggest Carrier, Proposes to End Code Stacking for Molecular Clinical Laboratory Tests

Preliminary findings about whole-genome sequencing of triple-negative breast cancer presented

Next-Generation DNA Sequencing to Improve Diagnosis for Muscular Dystrophy

More Community Hospital Pathology Laboratories Are Ready to Tackle Molecular Testing for Infectious Disease and Cancer