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…

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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 professio…

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FDA Clears Waived CBC For Near-Patient Testing

CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…

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Study Reveals Medicare Already Pays Low Rates

CEO SUMMARY: Researchers studied a database containing laboratory test prices paid in 2012 on behalf of 56 million Americans covered by private health plans and determined that, for most tests, and in most regions, Medicare already pays less than private health insurers for clinical labor…

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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 Universi…

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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 afte…

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Siemens’ IVD Purchases Are a Major Investment

CEO SUMMARY: In the space of just nine weeks, Siemens AG purchased Diagnostic Products Corp. (DPC) and Bayer Diagnostics. Siemens paid $1.86 billion and $5.31 billion, respectively, for the two invitro diagnostics (IVD) companies. Once it closes the acquisition of Bayer Diagnostics, Sieme…

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Online Distance Training Helps Labs Recruit & Retain More MTs

CEO SUMMARY: One surprise about online distance learning (ODL) programs for medical technologists (MT) is that even small hospital laboratories can use them to recruit and train more MTs. Across the United States, a growing number of labs are experiencing a shortage of MTs in their local …

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Med Tech Training Via Long-Distance Programs

CEO SUMMARY: Students from as far away as Oregon and Hawaii are using the online distance training program at the Medical College of Georgia, located in Augusta, to get their Bachelor of Science degree and medical technologist certification. Because many regions do not have a local MT tra…

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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,…

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