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

Annual growth rates of 11% or more is predicted for molecular diagnostics in coming years

Just as consolidation and acquisitions reshaped the in vitro diagnostics (IVD) manufacturing industry and concentrated market share among just a handful of multi-billion dollar IVD giants, a similar consolidation can be seen in the molecular diagnostics sector. Today it is estimated that just nine global companies control 75% of the molecular diagnostics market.

That market concentration means clinical laboratories and anatomic pathology groups have a just a handful of primary vendors from which to purchase many of the molecular diagnostic assays and genetic tests that are used most frequently in clinical care.

Frost and Sullivan published a detailed study about the molecular diagnostics marketplace. The consulting firm estimated that worldwide sales of molecular diagnostics totaled $4.1 billion in 2010. By contrast, total IVD sales globally were about $48 billion in 2010. That total includes the routine, reference, and esoteric test kits, reagents, and supplies used every day by medical laboratories.

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Mobile Medical Laboratory Brings High-Complexity Infectious Disease Testing to South Africa’s Remote Regions

Immediate access to TB and HIV testing means faster diagnosis and treatment for patients in remote areas

Use of a new mobile medical laboratory is boosting access to quality diagnostic testing for patients in remote areas of South Africa, while slashing turnaround times and courier costs. This German-built mobile clinical laboratory performs high complexity testing and may provide a new model for diagnostic testing for other developing countries.

Fraunhofer Institute for Biomedical Engineering (IBMT) in Saarland, Germany, built the $2 million mobile medical laboratory in collaboration with the government of the Western Cape, a province in southwest South Africa.

The clinical lab-on-wheels operates as an extension of the Caledon Hospital. This is a 75-bed community hospital located in the Overberg district, about 62 miles east of Cape Town. Specimens are sent to the mobile laboratory from health facilities in the surrounding area.

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More Use of Whole Gene Sequencing Poised to Play Important New Roles in Microbiology and Medical Laboratory Testing

Cheaper, faster, and more accurate rapid gene sequencing technologies show great promise in identifying infectious disease agents

In clinical laboratories across the nation, microbiology has greatly benefited from the introduction of molecular diagnostics in clinical practice. Now the field of microbiology is poised to undergo a more profound transformation of clinical practice, due to advances in whole genome sequencing.

Leaders in this field are calling these developments “transformative” and say they have the potential to change “all aspects of microbiology.” The driver to this emerging trend is advanced technology that makes it possible to sequence the whole gene sequence of an organism in a day or less, for a cost that is $1,000 and falling rapidly.

In the past six months, microbiologists and pathologists at such hospitals as Methodist Hospital in Houston, Texas, have begun to do whole genome sequencing of microbes found in specimens collected from patients arriving in the emergency room. The New York Times wrote about these developments in a story titled “The New Generation of Microbe Hunters,” that it published on August 29, 2011.

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Teaching the Next Generation of Clinical Pathology Laboratory Managers

MLO and The Dark Report award scholarship to Medical Technologist from Uganda

During the next five years, experts predict a significant turnover of senior executives and administrators in the nation’s clinical laboratories and pathology groups. One big reason why this will occur is the surge of retirements expected as members of the baby boomer generation turn 65.

That makes it ever more important for all medical labs to prepare their next generation of clinical laboratory managers . That is also the goal of a unique collaboration between Medical Laboratory Observer (MLO) and The Dark Report. Each year, for more than five years, the two publishers have teamed up to offer a full scholarship to the Executive War College on Laboratory and Pathology Management. This scholarship includes travel and hotel expenses.

Scholarships for Clinical Laboratory Managers

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New Rapid Molecular Pathology Test for Tuberculosis Wins Favor with World Health Organization

Medical Laboratory Test Offers Improved Accuracy and Faster Time-To-Answer

It’s big news when an international health body endorses a new proprietary clinical laboratory test. That’s why pathologists will be interested to learn that, earlier this month, the World Health Organization (WHO) publicly recommended that nations incorporate a new rapid molecular test for tuberculosis into their disease testing programs.

The clinical laboratory test that the World Health Organization endorsed is the Xpert MTB/RIF test manufactured by Cepheid (Nasdaq: CPHD), the molecular diagnostics company based in Sunnyvale, California. The assay is a 100-minute rapid tuberculosis (TB) test. It is a fully-automated nucleic acid amplification test and WHO advised that the assay be introduced into clinical use under defined conditions as an integral part of a nation’s program to diagnose and treat TB and multi-drug resistant TB. (more…)

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