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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Pathology and Radiology Must Prepare for Personalized Medicine

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the current, commonly-used definition of companion diagnostics-as primarily measurement by use of serum biomarkers-is outdated.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: )

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A Tale of Two Analyzers and Other Thoughts from AACC 2008

There were plenty of new and interesting analyzers, lab tests, and other products on display this week in Washington, DC, at the exhibition during the annual meeting of the American Association of Clinical Chemistry (AACC). Dark Daily was there to take it all in and to identify emerging trends in laboratory and pathology management.

There were new instrument systems galore, because many in vitro diagnostics (IVD) manufacturers use the AACC exhibition as the place to unveil their latest generation of products. Two examples of new analyzers illustrate how technology advances are contributing to useful new capabilities.

For use in the core laboratory, Ortho-Clinical Diagnostics (OCD), a Johnson & Johnson Company (NSYE:JNJ), showed off its new VITROS 5600 Integrated System, which puts chemistry and immunoassay into a single, integrated platform. What caught Dark Daily’s attention is how this instrument incorporated Lean principles in its design and operation. For example, OCD calls it a “one-tube-in, one-tube-out” workflow guided by onboard intelligence to prioritize the next 50 tubes in the queue and handle them independently and in parallel for both chemistry and immunoassay. It has an onboard menu that will support 120 assays. Another intriguing aspect of this new instrument system is that, because it uses dry chemistry, there is no need for water or waste lines. That feature will give this instrument system an interesting appeal for laboratories that want flexibility in placing the instrument while eliminating the need for expensive remodeling to supply a water and waste line to the instrument. This instrument will be available for purchase by early 2009.

A second analyzer is designed to allow community hospitals to expand their molecular testing capabilities. HandyLab, Inc. of Ann Arbor, Michigan, was showing its Jaguar platform. This is an open system for molecular assays that will produce molecular results in 45 to 90 minutes. The random access Jaguar will perform specimen preparation, amplification, and real-time PCR automatically, using room temperature reagents. It can perform 1 to 24 samples at one time and will test up to 200 samples per nine-hour shift. The Jaguar has a competitive price and is designed to support laboratory developed tests (LDPs).

With more than 800 vendors exhibiting at the AACC event and only three days of exhibition hours, it is difficult for any single individual to get by all the booths and evaluate the innovations and new products being shown. One important trend that could be seen in walking around the exhibition is the number of new vendors showing proprietary assays and lab tests. A ballpark guess is that more than 50 firms with new lab tests were exhibiting at AACC for the first time. Also, the number of exhibitors in the international area has increased over the past year.

Finally, a personal comment. Your Dark Daily editor decided to allow himself to be tested at one of the companies offering a free test of their proprietary assay. I thought this would be an easy process, since I give blood regularly and phlebotomists always tell me I have good veins. In conversing with the phlebotomist as the draw was performed, I learned that this individual was a seven-year employee with one of the national laboratories. I also observed that, after inserting the needle in my arm, this phlebotomist was fooling around for more than 30 seconds attempting to get blood to flow from that site. I quietly encouraged her to withdraw the needle and try the other arm. That second venipuncture went successfully. By the way, as a former rugby player with more than two decades of playing experience and my share of stitches, the first attempt at venipuncture was not painful or agonizing. So Dark Daily readers can be assured that your editor was NOT traumatized, only the nearby observers were.

My comment on this experience is that it demonstrates the difficulties laboratories face in providing tip-top service to consumers. Additionally, the folks with me had a chuckle discussing about how the senior executives at that phlebotomist’s home company might react were they to learn that it was the Editor of Dark Daily and The Dark Report who experienced a less-than perfect venipuncture at the hands of their phlebotomist! It is also a reminder of the variability in care delivered to patients and why reducing such variability can give laboratories competitive advantage.

Regards and enjoy the remaining weeks of summer!

Robert Michel

Editor, Dark Daily