If there is one healthcare trend that will be truly disruptive to pathologists, it is personalized medicine. The concept behind personalized medicine is simple: understand the genetic and metabolic differences unique to the individual patient. Then use this knowledge to tailor a custom program of therapy, including prescription drugs, that offers the maximum potential for success while minimizing possible side affects.

Personalized medicine is closely linked to the emerging field of companion diagnostics. In combination, these two new ideas have the potential to revolutionize how laboratory testing services are used in developed healthcare systems. For one thing, clinical laboratories and anatomic pathology groups-traditionally the “go to” source for information to drive diagnostic, prognostic, and therapeutic decisions-will have serious competitors in the world of personalized medicine and companion diagnostics.

One keen observer of the personalized medicine trend is Bruce Friedman, M.D., Professor Emeritus of Pathology at the University of Michigan Medical Center in Ann Arbor, Michigan. In his popular LabSoft news blog, he defined companion diagnostics in this manner:

Briefly stated, [companion diagnostics] is a strategy pursued by some IVD companies, Roche Diagnostics in particular, whereby the company develops a gatekeeper biomarker assay. This is a lab test that serves to qualify a patient for treatment with a particular drug. The most common example of such a test is the HER-2/neu assay that is required prior to treatment with Herceptin.

Friedman, like your Dark Daily editor, recognizes that advances in genetic science and molecular technologies are making it possible for other medical specialties to crowd into the diagnostic field. He believes that the current, commonly-used definition of companion diagnostics-as primarily measurement by use of serum biomarkers-is outdated. He thinks the definition should be widened, writing in his blog that: “I personally have begun to routinely assume that diagnostics, unless otherwise qualified, should be more broadly defined to include both the analysis of serum and tissue biomarkers as well as medical imaging procedures. I have posted a number of notes about molecular imaging, which is defined in the following way in the Wikipedia:

[Molecular imaging] differs from traditional imaging in that probes known as biomarkers are used to help image various targets or pathways, particularly. Biomarkers interact chemically with their surroundings and in turn alter the image according to the molecular changes occurring within the area of interest. This is markedly different from previous methods of imaging which primarily imaged differences in qualities such as densities or water content.”

Friedman continues, saying: “I think that we now need to broaden our definition of companion diagnostics to include both the measurement of serum/tissue biomarkers as well as medical imaging and particularly molecular imaging. Such an approach also echoes my belief, expressed in a number of previous notes, that pathology, lab medicine, and radiology are becoming much more closely aligned and should now merge into a new discipline of diagnostic medicine. This broader definition for companion diagnostics also suggests that Roche, GE, and Siemens are embarking on very similar strategy in the pursuit of personalized medicine.”

All pathologists and radiologists should track this trend, which is poised to disrupt long-standing practices in their respective medical specialties. Friedman will speak on this topic at the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics in Philadelphia on February 10-11, 2009. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania. Joining Friedman is a faculty of 27 other leading national and international experts in molecular imaging, molecular diagnostics, and healthcare informatics.

Speakers from such organizations as Massachusetts General Hospital, Stanford University Medical Center, MD Anderson Medical Center, UCLA Medical Center, Siemens, and the Institute for Systems Biology will provide the latest innovations in the integration of in vivo and in vitro diagnostics. Last year’s Molecular Summit attracted 225 attendees, along with editors and reporters from 15 healthcare publications. This upcoming Molecular Summit has compelling case studies of how molecular diagnostics, when integrated with molecular imaging and other data sets, is giving clinicians powerful new insights for making diagnoses, identifying appropriate therapies, and monitoring patient progress.

Register today and guarantee your place at this important event for pathology and radiology! The full agenda and speaker line-up for Molecular Summit 2009 on February 10-11 can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/program.htm )

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