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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Illumina Intends to Migrate Array Technology to Clinical Laboratories

Firm will submit cytogenetic testing system to FDA using pre-IDE process

High-throughput microarray technology used in cytogenetics research may soon have an FDA-cleared product for use by clinical pathology laboratories.

Array-based comparative genomic hybridization can perform the equivalent of hundreds or even thousands of fluorescence in situ hybridization (FISH)  experiments in one array. This technology has become the preferred method for molecular cytogenetics research. Recent advances in the technology are making the system appropriate for use by clinical labs and at least one manufacturer is taking steps to enter this market. (more…)

Republicans and Democrats Offer Complex and Convoluted Healthcare Reform Charts

It’s a political slugfest which only reinforces the complexity of healthcare in this country

Get ready for the “Healthcare Reform Chart Wars,” brought to you courtesy of the two political parties. In the fight over the Obama Administration’s plan to reform healthcare, each side seems to be striving to offer up the most complex chart of how healthcare operates pre- and post-reform.

One chart (Republicans) skewers the complexity of the Democratic Party’s proposed reforms. The other chart (Democrats) demonstrates the convoluted intricacies of the existing American healthcare system. It appears that both Democrats and Republicans are engaged in this tussle with equal vigor and Dark Daily readers will enjoy the play-by-play of this unfolding farce.


Put April 28-29 on your calendar and join us for Executive War College 2009!

We’re Heading Back to New Orleans!

Get the latest and best in lab and pathology management!

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Make your plans to join us for the biggest and best Executive War College ever! Last year’s event was sold out and we plan to exceed it with timely topics, powerful speakers, and the profession’s best networking.

Executive War College 2009 will take place on April 28-29, 2009. Location will be the Sheraton New Orleans. After several years away, we are heading back to New Orleans!

As the lab industry’s leading showcase of innovative laboratories and pathology groups, it’s your best opportunity to get up close and personal with some of the nation’s best-performing laboratory directors and pathologists.

We’d also like to ask your help. What topics would you like to be presented at Executive War College 2009? Share your suggestions with us by emailing Besides topics, do you have speaker suggestions, including yourself? We work hard to locate some of the industry’s most interesting innovators. You may be among them, so let us know what your lab is doing!

In closing, don’t forget to mark your calendar and block April 28-29, 2009. We’d love to have you with us at the 14th Annual Executive War College!

Robert Michel

Multi-Modality Diagnosis Is New Trend That Integrates Imaging and Lab Testing

Today Dark Daily wants to introduce you to the emerging medical discipline of “multi-modality diagnosis.” Advances in genetics and molecular technologies are actively breaking down the traditional scope of practice for several medical specialists. At ground zero in this new area of medicine are pathology and radiology.

Multi-modality diagnosis can be defined in a simple manner. It is the use of several different types of clinical data-in an integrated fashion-to make a diagnosis. “Integration” is the key concept here, since physicians have always assembled information about the patient from several sources as they proceeded to evaluate the patient and make a diagnosis.

As doctors and researchers learn more about genetics and the role of DNA, RNA, and proteomics in various illnesses and ailments, there are huge increases in the volume of data now relevant in assessing the patient’s condition and determining the most accurate diagnosis. At the same time, medical specialties, particularly those of radiology and pathology, that formerly could work somewhat independently to evaluate the patient and provide the referring clinician with a report that was rather straightforward and simple, now face a new challenge. The expanding knowledge base of genetic and molecular information means that their evaluation of the patient needs to incorporate the findings of other medical specialists if the final assessment is to be accurate and useful to the referring clinician.

In other words, genetic medicine is the active catalyst that is already motivating different medical specialties to interact more closely to assess and diagnose certain types of diseases. At the forefront of this trend are progressive radiologists and pathologists-specifically those working with molecular imaging and molecular pathology. For example, in leading academic centers, it is growing ever more common for the neuropathologist and the neuroradiologist to review each other’s images before signing out their respective cases. In some laboratory settings, these two subspecialists are already developing a single, integrated report that goes to the referring physician.

Healthcare informatics is another channel of innovation propelling multi-modality diagnostics forward. Independent of pathology and radiology, there are informaticians pulling together disparate sets of patient data, then running this data through sophisticated software algorithms to develop diagnostic information that gives the patient’s physician new knowledge. Within the field of healthcare informatics, these innovators constantly describe their work as bringing together multiple modalities of data. Dark Daily readers should note that this effort is happening outside of the pathology and radiology specialties. It is an external trend to both professions.

Those interested in learning more about multi-modality diagnosis have two resources. In a recent issue of The Dark Report, a detailed intelligence briefing was published on this topic under the title “Multi-Modality Diagnosis Heading for Lab Medicine.” Dark Daily subscribers who would like a complementary copy of this intelligence briefing should contact Ron Martin at

The second resource for learning more about multi-modality diagnosis is the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics On February 10-11, 2009, national and world leaders in molecular imaging, molecular diagnostics, and integrated informatics will be leading strategic sessions and case studies on this subject. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania.

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 next 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.

The full agenda and speaker line-up for this year’s Molecular Summit can be viewed here (or paste this URL into your browser: )

Make your plans to join us at Molecular Summit 2009 to learn how your laboratory can benefit from multi-modality diagnostics.

Early-Bird Discount Registration now available online

Download Full Program 2009 Agenda

Four Easy Ways to Register:
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Big Policy Shift on EMR and E-Health by American College of Physicians

It’s big news when the nation’s largest medical specialty organization shifts its policy on physician use of electronic medical record (EMR) systems and e-health services. The American College of Physicians (ACP), in Philadelphia, Pennsylvania, issued a new position paper.

ACP says that physicians, patients, technology companies, and policymakers must collaborate to foster e-health activities and electronic communication among physicians and patients. ACP further states that e-health activities-including remote monitoring of patients, personal and electronic health records, and patients seeking health information on-line-have the potential to transform health care in the United States!

“E-health activities have great potential to improve the quality of patient care, reduce medical errors, increase efficiency and access to care, and achieve substantial cost savings,” said ACP President David C. Dale, MD, FACP. “Furthermore, e-health is a critical part of the patient-centered medical home model of care, which in coordination with the other components, is the future of the U.S. health care delivery system.”

The new positions adopted by the ACP are useful for those pathologists and laboratory directors tracking acceptance of new technologies by physicians. Laboratories that establish electronic links with their physician clients end to enjoy a more productive relationship with those physicians.

The ACP’s new position paper is significant for two more reasons. First, it is a statement by ACP that its 125,000 physician-members are ready to embrace and adopt these new technologies. That’s a change from past years, when healthcare lagged other industries in its adoption of information systems and new technology. Second, physicians have been criticized for their collective reticence to adopt electronic medical record systems. The ACP’s position paper specifically calls for physicians and other stakeholders to recognize the potential that information technology holds for transforming healthcare.

“A recent report from the Robert Wood Johnson Foundation estimates electronic medical record (EMR) use in the ambulatory (physician) setting at 24% and in the inpatient (hospital) setting at 61%,” stated the ACP in its position paper. “According to a 2006 ACP member survey, adoption also varies by practice size; smaller practices (five or fewer physicians) have an adoption rate of 18%, while larger groups, (20 or more physicians) have an adoption rate of 58%. Those practices that have implemented EMRs may also include such services as online appointment self-scheduling and secure patient-physician messaging. This interaction between patients and their physicians through the use of electronic tools for health-related purposes has been broadly defined as e-health.”

In addition to citing the potential the IT holds for healthcare, the ACP position paper also acknowledges the barriers to more widespread adoption of information systems in healthcare. For physicians, the challenges of implementing e-health systems can be substantial in part because IT is expensive and the return on investment is not always certain. “For physicians, the financial costs of purchasing systems and incorporating e-health offerings can be considerable,” ACP said.

ACP also recommended investment in demonstration projects to assess how e-health activities can support the relatively new concept of the patient-centered medical home. A patient-centered medical home is an approach to providing comprehensive primary care for patients of all ages and medical conditions. Dark Daily has already alerted its clients and subscribers to the growing support behind the medical home concept (See Dark Daily, August 8, 2008, Doctors Promote “Medical Homes” as Way to Take Us Back to the Future ).

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