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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Clinical Chemists and Medical Laboratory Professionals Gather at AACC’s Annual Meeting in Atlanta

Lots of products involving molecular diagnostics and genetic testing were on display at the exhibition

DATELINE: Atlanta, Georgia—Yesterday was the close of the 2011 annual meeting of the American Association of Clinical Chemistry (AACC). Organizers played host to what—pre-event—they announced was a record-breaking number of exhibit booths sold to vendors at the exhibition. Despite a rather quiet economy, there was plenty of traffic and much interest in products on display in the clinical laboratory.

Many lab industry vendors believe that there is pent-up demand by medical laboratories because of the long recession in 2008 and 2009, combined with the clamp-down on laboratory spending that resulted as hospitals and health systems slashed budgets during the recession to protect their cash flows. But now, having deferred equipment replacement for up to three full years, a number of clinical pathology laboratories have returned to the marketplace to acquire new medical laboratory testing equipment.

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Fully Automated Molecular Diagnostic Solutions Find a Home in Hospital Laboratories

New Load-and-Walk-Away Systems Promise Rapid Turnaround Times and Multi-Target Testing


Laboratory Automation is one important reason why more community hospital laboratories and local pathology groups can now perform a growing menu of molecular diagnostic tests. Rapid innovations in automation technology now make it possible for even low-volume medical laboratories to perform molecular testing using highly-automated “load and walk away” molecular analyzers.

Pathologists and clinical laboratory managers may be surprised to learn that the market for these simple-to-use automated analyzers is actually becoming crowded. There are at least five companies that now make bench top automated nucleic acid testing systems. These systems are designed to enable medium and low volume labs to compete in the nucleic acid testing arena. It is one reason why the number of community hospital laboratories and local anatomic pathology group practices are establishing molecular testing programs.
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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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