Mar 6, 2007 | Laboratory News, Laboratory Operations, Laboratory Pathology
During the past 12 months, Siemens and General Electric each invested several billion dollars to acquire in vitro diagnostic (IVD) companies. Snatched up by Siemens were Diagnostic Products Corp. and Bayer Diagnostics. General Electric has signed an agreement to purchase Abbott Laboratories Diagnostics in a deal expected to close within the next month.
By acquiring major IVD companies, both Siemens and General Electric have sent an unmistakable message. It is their expectation that the future of diagnostic medicine lies in the effective integration of imaging and in vitro diagnostics. Since both radiology and laboratory medicine generate scads of data, in recent years each company has acquired a vendor selling laboratory information systems (LIS). In the case of Siemens, it was Shared Medical Systems (SMS). General Electric acquired Triple G Systems. Further, both companies own EMR (electronic medical record) systems designed for use by office-based physicians.
Dark Daily believes it is not a coincidence that Siemens and General Electric are building almost identical capabilities to offer services that include imaging, IVD, software to handle data from imaging and laboratory testing, along with EMR and practice management software for office-based physicians. In classic economics, this is a strategy of horizontal integration. Wikipedia describes horizontal integration as “a strategy used by a business or corporation that seeks to sell a type of product in numerous markets.”
By that definition, Siemens and General Electric are building the components needed to provide diagnostic services to all segments of the healthcare market. Their goal is to integrate in vivo and in vitro diagnostics. They are assembling products that will be used by radiologists and pathologists to evaluate the patient and provide a diagnosis. This information will then be made available to referring clinicians and other relevant parts of the healthcare system.
So far, both Siemens and General Electric have offered few details about how their vision of integrated diagnostics will alter laboratory medicine as we know it today. That will change on Friday, May 10, 2007. On that day, Dave Hickey, Vice President of Strategic Marketing and Planning for Siemens Medical Solutions Diagnostics, will make a major speech at the Executive War College on Laboratory and Pathology Management. He will discuss “Full Service Diagnostics: The Coming Convergence of Imaging, Informatics, and In Vitro Diagnostics (IVD).”
Lab directors and pathologists have an opportunity to be first to learn why and how Siemens intends to integrate imaging, in vitro diagnostics, and healthcare informatics to provide clinicians with a full diagnostic report. Dark Daily considers it of particular interest that Siemens has talked about integrating these technologies in such a way as to allow physicians to diagnose disease when the patient is pre-symptomatic.
And if diagnosing patients who are pre-symptomatic isn’t radical enough, think about the implications of integrating radiology services with anatomic pathology! Traditionally, these are two medical specialties which have carefully guarded their scope of practice. Now two of healthcare’s largest companies are both committing billions of dollars to foster integration of radiology and pathology. These are reasons why Dave Hickey’s presentation at the upcoming Executive War College will provide useful insight and help guide strategic planning at pathology groups across the country.
You can get more details about Dave Hickey, his presentation, and the full Executive War College program at http://www.executivewarcollege.com. Make your plans now to see and hear Dave Hickey discuss how Siemens intends to integrate radiology and laboratory testing so you can prepare your laboratory for upcoming changes.
PS: To get the latest news and effective strategies dealing with new trends, join us in Miami on May 10-11, 2007 for the 12th Annual Executive War College. You can access the full details using the links below. Take action today to reserve your place.
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Feb 23, 2007 | Laboratory Management and Operations, Laboratory Pathology
With both Siemens and General Electric placing big bets on in vitro diagnostics during the past nine months, there is much speculation about plans to integrate pathology with radiology. Bruce Friedman, M.D., plans to tackle this subject at his fourth annual Lab InfoTech Summit, scheduled to take place in Las Vegas on March 5-7 at the Venetian Casino Resort Hotel.
Dark Daily asked Dr. Friedman about his thoughts on what would be the most significant change in laboratory information technology in the coming years. “The trend of merging and convergence of the clinical pathology laboratory with radiology is creating a lot of interest,” replied Friedman, “I will be speaking about it at the conference, along with a few other speakers touching on the idea.” Friedman has blogged about The Convergence of Pathology/Lab Medicine with Radiology in his LabSoftNews Blog on multiple occasions and believes it is the next necessary step in laboratory information technology.
Friedman is recognized as one of the leading authorities on clinical laboratory and anatomic pathology informatics. His Lab InfoTech Summit is designed for all clinical laboratory professionals, including pathologists, medical technologists, lab information system mangers, and lab business managers.
To complement the speakers making three days of presentations about important topics in laboratory information management solutions, the conference features two pre-conference workshops. One is titled “Assessing and Improving the Value of Lab Services” and the other is titled “Rules in the Clinical Laboratory: Design, Validation, and Process.” The use of rules in the clinical labs seems to be taking hold for functions such as autoverification of test results because this allows medical technologists to attend to higher level tasks than validating outgoing test results. Both these workshops are intended for lab professionals who want to actively participate in discussion about these topics. They will feature lecture, discussion, Q&A sessions, and networking opportunities.
Friedman went on to say that the Summit “will feature 43 exhibitors of lab software and allied products and more than 200 paid registrants. It is the largest specialized exhibition of its type in the US and is growing rapidly each year.” The Summit provides an excellent opportunity for laboratory professionals assess, compare, and contrast multiple laboratory software solutions. Conference attendees will be able to meet with multiple vendors, face-to-face, in one, convenient location.
The 2007 Lab InfoTech Summit will enable laboratory professionals to immerse themselves in the latest trends in laboratory information management for days. Don’t let this opportunity for learning and networking pass you by!
Feb 9, 2007 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Yesterday’s public forum conducted by the Food and Drug Administration (FDA) on proposed guidance to regulate a certain category of molecular diagnostic assays drew a surprisingly large and diverse number of presentations and comments from the laboratory, biotech, and healthcare industries.
When the FDA recently released two draft guidelines, one for commercially distributed analyte specific regents (ASRs) and another for IVD multivariate index assays (IVD-MIAs), it was hoping to address criticisms and claims of confusion. These two draft guidelines were largely the results of complaints that a 1997 FDA rule that defined and classified ASRs, establishing requirements and imposing restrictions, resulted in confusion.
The primary cause of confusion regarding IVD-MIA regulation circulated around IVD-MIAs that were both developed and used by laboratories. This confusion resulted because of FDA regulation of laboratory-developed or “home brew” tests. The draft guidelines from the FDA suggest that IVD-MIAs do not fall within the definition of laboratory-developed tests.
The Office of In Vitro Diagnostic Device Evaluation (OIVD) held a public meeting yesterday, February 8, 2007, to provide a public forum during which OVID heard presentations and comments from interested stakeholders. Dark Daily received the presentation materials from Alan Mertz, President of the American Clinical Laboratory Association, who made the following recommendations to achieve the goal of the Draft Guidance:
• First, ACLA recommends that FDA issue a proposed rule to address this important subject matter through the formal notice and comment rulemaking process rather than through sub-regulatory guidance.
• Second, ACLA recommends that FDA consider proposals to narrow and clarify its definition of IVDMIAs to avoid confusion and unintended consequences.
• Third, ACLA recommends that FDA work with CMS and through HHS to address its concerns through enhancement and better enforcement of the regulations promulgated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
“We appreciate that the FDA arranged the meeting,” said Mertz. “It was clear by the number of presenters how important this issue is to all sectors of healthcare, not just labs. I was struck by the number of concerns expressed about the current draft guidance by such a diverse group of stakeholders. We hope that FDA will take these concerns into full consideration if they choose to move forward.”
The gist of both Mertz’ presentation, and a November/December 2006 article in IVD Technology was that the goal of the draft guidelines was a good one, but the guidelines fall short of what they set out to accomplish. They do not further clarify what constitutes an IVD-MIA. Furthermore, the guidelines’ solution for enforcing these new FDA rules – reliance on complaints originating within the industry- is likely to result in companies turning on each other. That is not likely to serve the public health in an efficient manner.
Feb 2, 2007 | Laboratory News, Laboratory Pathology
Quest Diagnostics Incorporated announced yesterday that it purchased Sweden-based HemoCue for about $420 million. This purchase marks Quest Diagnostics’ first serious entry into the in vitro diagnostics (IVD) market and positions it in an unexpected segment of diagnostic testing.
HemoCue has global revenues of about $90 million per year, according to Quest Diagnostics. Its products are sold internationally. It provides point-of-care blood tests for hemoglobin, along with products for professional glucose and microalbumin testing. HemoCue’s handheld systems are used to screen for anemia and other conditions in physicians’ offices, blood banks, hospitals, diabetes clinics, and public health clinics. The company is currently developing hand-held systems to measure white blood cell count. Quest Diagnostics purchased HemoCue from a European-based private equity firm, EQT II BV.
Quest Diagnostics intends to integrate HemoCue’s handheld systems with its Care360 Portal, which gives doctors access to lab and medication records, patient medical history, and remote ordering of lab testing or prescriptions. Quest Diagnostics also said the deal will allow it to expand into international markets. “Technology is enabling diagnostic testing to move closer to the patient, and the acquisition of HemoCue and its exciting product pipeline gives us a strong presence in this emerging market,” said Surya N. Mohapatra, Chairman and CEO of Quest Diagnostics.
Dark Daily notes that Quest Diagnostics has been under stress to defend the business it gets from doctors who serve United HealthCare patients. The timing and nature of this acquisition have the appearance of a strategic move to shift the attention of investors away from Quest’s challenges with its United HealthCare book of business. As well, HemoCue’s $90 million in annual revenues will also help to replace revenue that Quest Diagnostics is expected to lose as a result of being excluded as a UnitedHealth provider in most markets since January 1, 2007.
