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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Medical Laboratories in Egypt Are Earning ISO 15189 Accreditation

Agreement with Germany’s INSTAND will include developing clinical lab proficiency testing program in Egypt

DATELINE: CAIRO, EGYPT—Here in Egypt’s capital city, the Egyptian Society of Laboratory Medicine (ESLM) is conducting its 22nd Annual Conference. One of Wednesday’s main sessions during this gathering of pathologists and clinical laboratory scientists centered on the topic of ISO 15189, as well as Lean and Six Sigma methods.

Your Dark Daily Editor, Robert Michel, is here in Cairo and delivered two presentations during this session. One presentation addressed growing global acceptance of ISO 15189. The second presentation discussed the adoption and use of Lean and Six Sigma by medical laboratories throughout the world. There is keen interest in ISO 15189 among Egyptian pathologists because the nation is incorporating ISO 15189 into its national program for accreditation of clinical pathology laboratories. (more…)

Cyber-Attacks against Internet-Enabled Medical Devices are New Threat to Clinical Pathology Laboratories

Veterans Administration and Hospitals Taking Steps to Prevent Hacking of Medical Devices and Wireless Systems

Clinical laboratories and anatomic pathology groups face a growing security threat to the integrity of their analyzers, laboratory information systems (LIS), and other devices used daily by their employees.

This rapidly-developing threat comes from outside hackers who are launching cyber-attacks aimed at the various medical devices and wireless systems that are directly connected to the Internet and are used by hospitals, physicians, and other healthcare providers. These cyber-attacks demonstrate a new vulnerability that clinical laboratories and pathology groups should recognize.

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Beckman Coulter Acquired by Danaher as In Vitro Diagnostics Industry Consolidates

Clinical pathology laboratory customers of Beckman Coulter shouldn’t see major changes

Yesterday came news that Danaher Corporation (NYSE: DHR) of Washington, D.C., would acquire Beckman Coulter, Inc., (NYSE: BEC) of Brea, California, in a transaction valued at $6.8 billion. Beckman is among the world’s larger manufacturers of in vitro diagnostics (IVD) analyzers and automation for clinical pathology laboratories.

For pathologists and medical laboratory administrators, the significance of the acquisition is that consolidation continues in the IVD testing industry. Beckman Coulter itself grew to substantial size through a series of acquisitions it completed over the past two decades. For 2009, Beckman Coulter reported revenue of $3.3 billion.

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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…)

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