Dec 18, 2009 | Laboratory News, Laboratory Pathology
Researchers say Mobidiag’s microarray-based diagnostic test technology looks promising
There’s a new DNA-based microarray platform that could speed identification of blood-borne pathogens. By allowing clinical laboratories to deliver test results in just 18 hours, use of this new microarray could improve early detection and management of sepsis patients.
In a study headed by Päivi Tissari, M.D., of the Division of Clinical Microbiology, Helsinki University Hospital Laboratory in Finland, the Prove-it sepsis assay, manufactured by Helsinki-based Mobidiag, demonstrated 94.7% clinical sensitivity, 98.8% specificity, along with 100% sensitivity and specificity for methicillin-resistant Staphylococcus aureus bacteremia. The conventional process of growing a culture—the medical laboratory’s gold standard—typically takes between one to three days to become positive and two more days to identify the bacteria and their antibiotic sensitivity patterns. Mobidiag’s Prove-it sepsis assay returns results in only 18 hours.
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Jun 3, 2009 | Laboratory News, Laboratory Pathology
Latest-generation DNA sequencing technology helped scientists achieve this feat
This spring, a particularly interesting milestone on the road to genetic medicine was achieved. The genome of Neanderthal man has been sequenced at the 1X level. It is a remarkable accomplishment by scientists from both the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and 454 Life Sciences Inc. , a division of Roche Holdings.
The final Neanderthal draft sequence is made up of three billion bases of Neanderthal DNA. This represents an estimated two-thirds of the entire genome. A research team has been assembled to evaluate and analyze the Neanderthal genome. Their findings may be published by the end of the year.
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Jul 12, 2007 | Laboratory News, News From Dark Daily
After the markets closed yesterday, General Electric (NYSE: GE) and Abbott Laboratories (NYSE: ABT) released announcements that the two companies had terminated the pending sale of Abbott’s two diagnostic business units to General Electric.
Abbott’s press release made the announcement in two sentences: “Abbott and GE have mutually agreed to terminate their contract for the sale of Abbott’s core laboratory and point-of-care diagnostics businesses to GE. The two companies were unable to agree on final terms and conditions of the proposed sale.”
GE’s press release said just a bit more: “General Electric announced today that GE and Abbott have agreed to mutually terminate their agreement relating to GE’s acquisition of Abbott’s primary in vitro and point-of-care diagnostics businesses. GE and Abbott worked diligently to complete the transaction but were unable to reach agreement on final terms and conditions. As a result, they agreed it was in the best interests of both companies to mutually terminate their agreement and discussions.”
The break-up of this deal is a significant development. For General Electric, it was a major healthcare acquisition. GE was ready to purchase Abbott’s primary in vitro diagnostics (IVD) business unit, along with a point-of-care testing business. Together, these Abbott businesses were estimated to generate about $2.5 billion in revenue last year. In fact, the price to be paid for of the Abbott diagnostics purchase was only slightly less than what GE paid for Amersham PLC in 2001, which was more than $9 billion.
There will be plenty of questions about why this deal fell apart. Was this a result of a changed financial picture at General Electric? Was something uncovered during due diligence that affected the acquisition as originally priced and structured – and the two parties could not negotiate a revised set of mutually-agreeable terms? Did either buyer or seller smell out a better deal, giving them motivation to see this acquisition agreement come apart?
Last year, Siemens (NYSE: SI) made similar investments to stake out a major position in the IVD marketplace. GE’s decision to abandon its acquisition of Abbott’s IVD businesses will probably not be the end of GE’s interest in in vitro diagnostics. It is probable that, in the coming months or years, GE will find another attractive IVD company to acquire.
Related Articles:
GE Announces Termination of Contract with Abbott
Abbott Announces Termination of Contract with GE
GE, Abbott end $8 bln deal for diagnostics business
GE, Abbott nix proposed $8B deal
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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.
Early-Bird Discount Registration now available online
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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.
