Apr 10, 2009 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
New diagnostic and treatment approach will require close interaction with Pathologists
There’s a novel diagnostic device designed to detect sepsis that also has to potential to engage the pathologist as part of the bedside care team. It is also an example of how nanotechnology and magnetism are being combined in ways that may support in vivo diagnosis and treatment.
Created by a research scientist at Children’s Hospital Boston, this new device uses magnetism to quickly pull disease pathogens out of infected blood. Experts predict it could become the first line of defense for sepsis, a disease which kills about 200,000 Americans each year.
The system works by drawing the patient’s blood and adding tiny magnetic beads, pre-coated with antibodies against specific pathogens, such as Candida albicans. The blood is run through a microfluidic system in which two liquid flow streams run side by side without mixing. One channel contains blood and the other contains a saline-based collection fluid. The beads bind to the pathogens. A magnet then pulls them, along with the pathogens, into the collection fluid. The collection fluid is ultimately discarded, and the cleansed blood reintroduced into the patient.
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Mar 2, 2009 | Laboratory News, Laboratory Pathology
Acquisition will particularly strengthen Beckman’s presence in clinical chemistry market
Monday, March 2, 2009
Last Friday, Beckman Coulter Inc. (NYSE:BEC) announced that it will pay $800 million acquire the diagnostics business of Olympus Corporation. This is a major transaction that further consolidates the in vitro diagnostics (IVD) industry, particularly given the respective market shares in clinical chemistry currently held by both Beckman and Olympus. (more…)
Dec 9, 2008 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
It’s no surprise that topping The Dark Report’s list of Top Ten Most Important Stories of 2008 for the laboratory industry is the successful repeal of the Medicare Part B Laboratory Services Competitive Bidding Demonstration Project. Across the nation, labs feared the consequences were federal health officials to have implemented the flawed scheme that was scheduled to commence in the San Diego-Carlsbad-San Marcos SMA (statistical metropolitan area) by July 1, 2008.
Our list of the Top Ten Most Important Lab Industry Stories of 2008 leads off the latest issue of The Dark Report, published last week and arriving at client’s locations here and abroad. This annual listing is closely-watched because it provides a clear assessment of major trends unfolding in laboratory medicine.
Editor-In-Chief Robert Michel, after explaining why repeal of Medicare Competitive Bidding was the single most important development during 2008, characterized the balance of 2008 as otherwise a quiet and relatively uneventful year. He wrote “No other story on the Top Ten list approaches the magnitude of importance and implications of Medicare competitive bidding repeal. However, that is a good thing because it means that, over the course of 2008, there were few events that represented disruptive or unwelcome change to the majority of laboratories and pathology group practices.”
In fact, Editor Michel picked the huge increase in the volume of Vitamin D testing as the second most important lab industry story for 2008. “This phenomenon is directly related to widespread media stories about: 1) the alarming increase in the number of people with Vitamin D deficiency; and, 2) the negative health consequences for individuals who are deficient in Vitamin D,” noted Michel in The Dark Report. “Attention to Vitamin D deficiency during the past two years shows how speedily a new clinical guideline can become accepted, particularly when it is something that is easy for consumers to understand.”
Top story number ten was described as “2008-Not a Year for Big Lab Deals as Relative Calm Rules Lab Market.” Michel observed that no major or disruptive laboratory acquisitions took place during the year. He noted how this was unusual for a trend that reaches back to the mid-1980s. However, it remains true that Wall Street is keenly interested in molecular diagnostics. That was reflected in the willingness of Roche Holdings (NYSE: RHHBY) to pay the premium price of $3.4 billion last April to acquire then $290 million Ventana Medical Systems. (See Dark Daily, “Roche Purchases Ventana by Offering Higher Price”, February 22, 2007).
Subscribers and readers of Dark Daily are invited to send in their picks for the most important medical laboratory stories for 2008, along with their reasons why the story is significant. We will publish the best of these submissions. E-mail to: rmichel@darkreport.com.
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2008’s Top Ten Lab Stories Lacked Disruptive Impact
Nov 21, 2008 | Laboratory News, Laboratory Pathology
Here’s another example of taking existing laboratory technology and applying it in a new way. A scientist at Queen’s University Belfast in the United Kingdom is using an existing technology to create what he describes as “intelligent molecules,” capable of identifying tags in human cells that could signal the presence of organisms common in an epidemic. They also could be use to track infections in a population and identify patients who would be vulnerable to certain infections.
This new application of existing technology earned A. Prasanna de Silva, Ph.D., Professor and Chair of Organic Chemistry at Queen’s University, the 2008 Royal Society of Chemistry’s Sensors Award, sponsored by GE Healthcare. The award is given biannually for chemical input into the design of novel sensors or novel applications of existing sensors.
The technology incorporates fluorescent “catch and tell” sensors that emit light signals when they catch chemicals in the blood. It is familiar technology to most laboratories, as it is incorporated into in blood diagnostic cassettes sold worldwide. Hospitals, ambulances, veterinarians, and others use this fluorescent sensor technology to monitor blood for levels of common salt components such as sodium, potassium, and calcium.
The worldwide market for this type of blood diagnostic cassettes totals $50 million. Roche Diagnostics Inc. uses the fluorescent sensor technology in the chemistry module of the OPTI point-of-care blood analyzer, a module that has produced worldwide sales of $39 million.
Using an extension of the same design, de Silva has developed molecules that act as ‘logic gates,’ which are similar to the mechanisms in computers. De Silva and colleagues at Queen’s University are using these molecular logic gates as identification tags for objects the size of biological cells.
The new application could be used in a variety of clinical and other settings, de Silva said. “One such use could be as an ID tag for cells in an epidemic, such as a bird-flu outbreak,” he explained. “From a population, our sensor molecules could help track infection and highlight vulnerable people. Another one is a ‘lab-on-a-molecule’ system which combines several lab tests with a rudimentary diagnosis without human intervention.”
This example demonstrates how advances in science, combined with the ongoing ability to continually shrink the size of diagnostic analyzers, will package long-established and familiar diagnostic technologies in new ways. It is a reminder that, outside today’s clinical laboratory, large numbers of research projects and biotech companies are rapidly developing new assays. It is one reason why laboratory medicine is almost overwhelmed by the daily and weekly stream of press releases and product launches for new biomarkers and new laboratory tests.
Related Information:
New ‘Catch-And-Tell’ Molecules Designed By Queen’s Chemist
New ‘Catch-and-tell’ Molecules Send Out Light Signals When They Catch Chemicals In Blood
Oct 28, 2008 | Laboratory Management and Operations, Laboratory Pathology
Federal officials underestimated the costs and time needed to implement the complex new codes for ICD-10, according to a new study released last week on October 14. As a result, laboratories and physician groups can expect to incur significantly higher costs to convert from the current International Classification of Diseases, Ninth Revision (ICD-9), to ICD-10.
The report by Nachimson Advisors, LLC, estimated that every provider will incur conversion costs in at least six ways. The report detailed and projected these costs for physician groups of small, medium, and large. It calculated that the typical small group of three physicians would incur costs of $83,290 to comply with ICD-10. A typical medium-sized group of 10 physicians would spend $285,195, and a typical large physician practice of 100 providers would spend $2,728,780. These costs include expenses for: 1) education; 2) process analysis; 3) changes to superbills; 4) information technology; 5) documentation; and, 6) cash flow disruption. Detailed coverage of the impending conversion to ICD0-10 is provided in the current issue of The Dark Report that was published on October 20, 2008.
One large laboratory with operations nationwide estimated that it will spend about $40 million to convert to ICD-10, including costs for information technology and staff education. This national lab further stated that implementation of ICD-10 code sets is projected to be twice as expensive as implementing the National Provider Identification (NPI) system that caused severe cash-flow problems for labs earlier this year.
A group of organizations representing physicians and laboratories, including the American Medical Association (AMA) and the American Clinical Laboratory Association (ACLA), commissioned the report. The deadline for compliance with ICD-10 is October 1, 2011, but physician trade groups are lobbying Congress to order the federal Department of Health and Human Services (HHS) to delay implementation. One reason the conversion is complicated is because ICD-10 uses 155,000 seven-digit codes, compared to the existing 17,000 codes in ICD0-9. Conversion will be particularly complex for laboratories because of the extensive system changes and the need to train not only staff, but the physicians who refer specimens to the laboratory.
“We have known this transition was going to be a big problem for a few years,” said ACLA President Alan Mertz. “The Nachimson study confirms that belief. ACLA has also consulted with our members and some of the larger labs tell us the costs for transitioning to the new codes and then the ongoing costs to use the new codes will be quite high. It will be costly for lab billing personnel to have to go back to the referring physicians to get the right diagnosis codes.”
Joseph M. Heyman, M.D., Board Chair of the AMA, said, “The AMA is deeply concerned that HHS is rushing head-first into the transition to a complex coding system without fully recognizing the impact on the health care system. Physicians, insurers, medical labs and others are raising the alarm that the costs, documentation and training required by ICD-10 will be significantly greater than HHS now recognizes.”
Medical laboratories and pathology group practices will need to develop a strategy for handling the transition from ICD-9 to ICD-10. Although providers are already pressuring federal health policymakers to delay the October 1, 2011 implementation date for ICD-10, there are many reasons why the United States must move to ICD-10. These reasons are detailed in current issue of The Dark Report.
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