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ivd manufacturer

IVD Firms Report Strong Growth Because of COVID-19 Testing

TO NO ONE’S SURPRISE, THOSE IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS that produce molecular tests, instruments, and automation used for COVID-19 testing reported strong growth in revenue and profits during 2020.  In recent weeks, these companies issued t…

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Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain

CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government…

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Value-based healthcare launches new conflicting interests for hospital labs, independents

This is an excerpt from a 2,400-word article in the Nov. 20, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Her…

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Paths of Hospital Labs, Independent Labs Diverge

CEO SUMMARY: With each passing year, the primary role of hospital and health system labs evolves in a different direction than that of independent lab companies. This trend is a response to the creation of integrated delivery networks paid on value and how they are scored on their ability…

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Finally, Abbott Buys Alere to Become #1 in POCT

CEO SUMMARY: After nearly two years of legal battles, Abbott Laboratories’ acquisition of Alere concluded on Oct. 3. Despite antitrust requirements to divest several of Alere’s diagnostic businesses to Quidel and Siemens Healthineers, the merger makes Abbott the world’s largest provider…

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Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …

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Benchmarking with the Best To Be a World Class Laboratory

CEO SUMMARY: This fourth installment of this special series about the laboratory value pyramid introduces “Level Four: Use Benchmarks to Achieve Best-in-Class.” This is the highest level of the four level pyramid. When a lab organization performs at this level, it will be deliver…

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PerkinElmer Launches Lab Venture in China

CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neona…

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NorDx CEO Shares Five Rules Critical to every Lab’s Success

CEO SUMMARY: To meet the financial challenges of healthcare today, clinical labs and pathology groups can follow the five classic lab rules of success. However, as noted by Stan Schofield, CEO of NorDx Laboratories in Scarborough, Maine, the “old school” methods need …

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Clinical Labs Spending Money in New Ways

CEO SUMMARY: In response to the many changes now unfolding in the U.S. healthcare system, labs are investing their scarce capital in different ways. Five trends in lab spending can be identified. They range from expanding the informatics capabilities of a lab organization to acquiring the…

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