Tag: laboratory diagnostics

FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access

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Digital Pathology Enables UCLA–China Lab Connection

CEO SUMMARY: Digital pathology holds the promise of interconnecting pathologists around the globe in ways that advance diagnostic accuracy and improve patient outcomes. One pioneering digital pathology collaboration involves the pathology departments at the medical schools of the University of California, Los Angeles (UCLA) and Zhejiang University in Hangzhou, China.

PART ONE OF A SERIES

DIGITAL PATHOLOGY

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Scripps’ Tumor Board Finds Value in Digital Imaging of Slides

CEO Summary: When the Pathology Department at Scripps Memorial Hospital in La Jolla, California, was considering the purchase of a digital imaging system, it gained unlikely allies. Non-pathologist physicians participating in the department’s tumor boards advocated for the purchase after seeing a demonstration. Pathologists at Scripps are preparing for a future in which digital imaging

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Major Changes at Dade Behring Soon to Be Visible In Lab Market

Its recent financial restructuring now complete, Dade Behring prepares a “brand building” campaign

CEO SUMMARY: Dade Behring is poised to become a tough and high-profile competitor in the laboratory diagnostics marketplace. Earlier this month, it finalized a major financial restructuring. Following two years of negotiations with its banks and bondholders, Dade filed a “pre-pack- aged” Chapter

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