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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Novartis To Pay $470 million To Buy Pathology Testing Company Genoptix

Cancer Testing and Molecular Diagnostics Are Main Drivers in This Transaction

In a deal with implications for independent clinical pathology laboratories, pharmaceutical giant Novartis (NYSE: NVS) announced that it would acquire pathology testing company Genoptix, Inc. (NASDAQ: GXDX). Novartis will pay $470 million in cash to acquire all the shares of Genoptix.

Although the total amount of $470 million to be paid for Genoptix is nearly one-half billion dollars, one financial analyst who quickly responded to the news believes that Novartis did not pay a premium price for Genoptix. At William Blair & Company, Analyst Amanda Murphy, CFA, wrote that “…the valuation [of Genoptix] is below what esoteric/specialty labs have been sold for in the past (closer to 10 times or more), which might reflect the company’s recent operational issues and/or potential reimbursement pressure from a shift to in-network status with payers.”
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Pathologists and Clinical Labs Can Expect to See More Companion Diagnostic Tests

Pharmaceutical Companies Partnering with IVD Manufacturers to Develop Companion Diagnostic Tests for their Therapeutic Drugs

Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. In 2010, it was increasingly common to see a pharmaceutical company announce an agreement with an in vitro diagnostics (IVD) manufacturer to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.

As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs. Thus, the increased number of public announcements during 2010 about companion diagnostic test development deals involving a pharmaceutical company and an IVD manufacturer indicates this trend is establishing solid roots. (more…)

Clinical Pathology Laboratories Use Lean to Design “Ideal” Blood Draw Sites and Workflow

Goal is for medical laboratories to enhance patient’s phlebotomy experience


DATELINE: San Antonio, Texas—Here in the Alamo City this week, many of the nation’s most innovative clinical laboratories, pathology groups, and in vitro diagnostics manufacturers came together to share their successes in the use of Lean, Six Sigma, and similar process improvement techniques.

The occasion was the Fourth Annual Lab Quality Confab and Performance Improvement Institute. This high-energy event was notable for several reasons. First, despite a lackluster economy, attendance was up more than 20% over last year. When asked about their participation, many attendees said that their parent hospital or health system sent them to the Lab Quality Confab specifically to bring back ideas for quality improvement projects that would advance clinical care while taking costs out of laboratory operations.

More Medical Laboratories Now Use Lean and Six Sigma Methods

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Inside the Recent CLMA and USCAP Meetings

Last week, The Dark Report was in San Diego and Houston to attend the annual meetings of the United States & Canadian Academy of Pathology (USCAP) and the Clinical Laboratory Management Association (CLMA). Time spent in the exhibit halls of both meetings spoke volumes about the changing trends in the laboratory profession.

First was the USCAP meeting, conducted in San Diego, California. This is a growing meeting and attracts more than 3,000 pathologists from countries around the world. One can hear many different languages spoken as one walks among the crowd between sessions. The exhibit hall of USCAP is also growing. It featured 245 exhibitors and represented a good cross section of companies selling instrument systems, consumables, and services to anatomic pathology laboratories.

Of particular note were two things seen in USCAP’s exhibition hall. First, there was an intriguing spread of companies offering digital solutions for anatomic pathology. Technology is advancing and, even if the current generation of products fall a bit short of the functionality desired by customers, it is clear that lots of money is being invested to advance all aspects of pathology informatics and digital imaging. Second, molecular pathology was definitely a major product sector at this exhibition. Whether it was the marketing of new diagnostic assays or companies offering services in molecular pathology, there was high interest in how molecular pathology could be used to provide higher quality diagnostic support to pathologists and their referring clinicians.

Following the USCAP meeting, I flew to Houston, Texas to catch the CLMA annual meeting. Just as laboratory consolidation in the hospital industry over the past decade has steadily concentrated laboratory management duties into the hands of fewer people, CLMA has seen a corresponding shift in the numbers of attendees and the composition of vendors in its exhibition hall. One obvious difference from past years is the lower profile of several in vitro diagnostic (IVD) companies at this year’s event. Yet, a survey of vendors throughout the exhibition hall indicated that the people passing through the exhibition were qualified buyers and their expectation was that new business would be result from their participation at the exhibition.

Just as at the USCAP exhibition hall, CLMA’s exhibitor line-up featured a growing number of software and informatics vendors compared to past years. I take this as a sign that laboratory directors and pathologists are taking active steps to use information technology to guide their management of laboratory operations and work flow. The range of middleware solutions and vendors on the exhibition floor would be a response by vendors to the demand for those functions by laboratory customers.

Another observation was gained from attendance at the annual meetings of USCAP and CLMA. There is plenty of optimism about the future of laboratory medicine among attendees and vendors at both events. Despite the rapid pace of change in healthcare and unfavorable reimbursement trends, pathologists and laboratory managers believe that new diagnostic tests and advances in laboratory medicine are giving them important new tools to help patients and their physicians.

Your traveling editor,
Robert Michel

Send your comments and observations to Robert at rmichel@darkdaily.com.

Immunoassay and Infectious Disease Analyzers Evaluated during Use by Clinical Pathology Laboratories

Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems


It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web.

The report is titled “Using Quality Management Methods to Compare Competing Mid-Volume Segment Immunoassay Systems that Perform Infectious Disease Testing.”  This report can be immediately downloaded and viewed by visiting the darkdaily.com web site.

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