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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National Institutes of Health Creates Partnership with Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals

Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.

Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)

Researchers at Stanford University and Intel Develop Silicon Microarray Chip Capable of Producing Clinical Pathology Laboratory Test Results in Minutes

Pathologists and clinical laboratory managers take note—this peptide chip microarray may have a role in point-of-care testing

At the heart of a new point-of-care technology is a prototype silicon chip that contains up to 9,000 peptides and allows real-time analysis in just minutes. Researchers say this technology can significantly reduce the time-to-answer when compared to existing clinical laboratory testing technologies.

This new prototype silicon chip is an on silico peptide microarray. It could help researchers better understand how proteins interact in the body. In turn, that will lead to improved diagnoses of numerous diseases. (more…)

Genetic Testing Used at University of Florida to Deliver Personalized Medicine to Cardiac Patients

Pathologists are helping care team interpret genetic laboratory test results for patients in the cardiac catheterization laboratory

Genetic tests will be part of the regular care protocols for some cardiology patients at both the University of Florida (UF) Clinical and Translational Science Institute (CTSI) and Stanford University Medical Center. Among other factors, it is faster time-to-answer and the lower cost of certain genetic technologies that make it feasible to use genetic tests in this care setting.

In particular, the genetic tests will be used to guide cardiologists as they make therapeutic decisions. Assisting in the interpretation of these tests will be pathologists and clinical laboratory professionals. (more…)

Rapid Progress in Systems Biology Predicted to Increase Multiplex Testing by Clinical Pathology Laboratories

Trend from reductionism to holistic biomedicine means clinical laboratories and pathologists should expect increased multiplex testing

Systems biology (SB) is a rapidly-evolving area of research that, by itself, could greatly expand the need for multiplex testing performed by clinical laboratories. But systems biology has yet to catch the full attention of either the media or Wall Street.

That may soon change. Despite the complexity of human metabolic systems, experts in systems biology are making progress in identifying the myriad of metabolic channels that collectively can be used to diagnose disease and identify appropriate therapies. These are auspicious developments for medical laboratory managers and pathologists.

Probably no single individual has done more to advance the field of systems biology than Leroy Hood, M.D., Ph.D. In 2000, he co-founded the Institute for Systems Biology (ISB) in Seattle, Washington and his colleagues engaged scientists across a number of fields to study the metabolic processes of humans and other organisms.
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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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