May 25, 2012 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories
Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market.
On May 15, the 17 voting members of FDA’s Blood Products Advisory Committee (BPAC), concluded that the benefits of the OraQuick in-home HIV test outweigh the potential risks for consumers, according to a story published at cbsnews.com. The FDA advisory panel’s decision came despite earlier reported concerns regarding decreased accuracy of the OTC test when performed by consumers as compared to results from the professional-use version.
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Mar 19, 2012 | Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology
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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Mar 5, 2012 | Laboratory Instruments & Laboratory Equipment, Laboratory Pathology
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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Jan 30, 2012 | Laboratory News, Laboratory Pathology
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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Apr 11, 2011 | Laboratory News, Laboratory Pathology, News From Dark Daily
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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