One of the big seven companies that control approximately three-quarters of the IVD market, Beckman Coulter (Fullerton, CA) was formed by a 1997 megamerger between Beckman Instruments Inc. and Coulter Corp. Since that time, the company has forged one of the broadest product lines in the IVD industry, transforming itself into the market leader in clinical chemistry and hematology and a major provider of immunoassay systems.
John P. Wareham is chairman, president, and...
Automation of pathology testing in clinical laboratories is growing rapidly. With a number of new systems for automated reading and preparation of Pap-smear slides already approved by FDA, automated equipment for diagnosing other diseases or conditions is now in the works. Despite having to overcome such hurdles as poor reimbursement rates and sometimes almost prohibitive laboratory start-up costs, the technology is now being readily adopted.
NeoPath (Redmond, WA) and AutoCyte (Burlington, NC)...
Clinical laboratories today are facing many challenges in order to remain competitive. These challenges are a result of a combination of market forces, including the continued reduction of government reimbursement rates for laboratory tests, cost-restraint measures from the managed care industry, and an overall move toward containment of national healthcare costs.
As pressures increase for clinical labs to become more productive and cost-efficient, they are forced to look more closely...
A few months ago, I had the pleasure of writing the cover story on clinical diagnostics for our sister publication, Medical Device & Diagnostic Industry. This was an assignment I relished, in part because it gave me an opportunity to talk with lots and lots of IVD manufacturers and to learn about the kinds of products they are developing.
Needless to say, automated systems were high on the priority list. Such systems include small laboratory analyzers and point-of-care devices with...
Take some automated hematology experience from Abbott Diagnostics (Santa Clara, CA), add a little immunodiagnostic technology from Becton Dickinson Immunocytometry Systems (BDIS; San Jose), and what do you have? A novel, fully automated immunohematology analyzer.
An automated platelet analyzer is the first product born of the Abbott/BDIS alliance. It combines the BDIS CD61 monoclonal antibody and reagent technology with Abbott's Cell-Dyn 4000 hematology system. The new systems promise to...
Makers of integrated testing systems may be encouraged to know that demand for their equipment among laboratorians is remaining steady. But companies producing total laboratory automation equipment may have a long way to go before they convince potential purchasers to buy their systems.
Those are among the key results of a survey of senior-level lab managers conducted by the Clinical Laboratory Management Association (CLMA; Wayne, PA) last May and June, and released in October. Responses...
Most testing for osteoporosis involves x-ray or ultrasound technologies that do not lend themselves to automation. Metra Biosystems, Inc. (Mountain View, CA), however, is hoping to corner the high-throughput osteoporosis screening market with release of its deoxypyridinoline crosslinks (Dpd) immunoassay.
Dpd is a recognized marker of bone resorption that is excreted in urine. Metra's test can be used to support a decision to initiate antiresorptive therapy and to monitor its...