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Paths of Hospital Labs, Independent Labs Diverge

By Robert Michel | From the Volume XXIV No. 16 – November 20, 2017 Issue

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…

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

By Mary Van Doren | From the Volume XXIV No. 16 – November 20, 2017 Issue

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…

Finally, Abbott Buys Alere to Become #1 in POCT

By Jon Stone | From the Volume XXIV No. 15 – October 30, 2017 Issue

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…

Proposed Bill in Congress Would Regulate LDTs

By Joseph Burns | From the Volume XXIV No. 7 – May 15, 2017 Issue

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 …

Benchmarking with the Best To Be a World Class Laboratory

By Robert Michel | From the Volume XXII No. 5 – March 30, 2015 Issue

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…

PerkinElmer Launches Lab Venture in China

By Joseph Burns | From the Volume XXII No. 4 – March 9, 2015 Issue

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…

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

By Joseph Burns | From the Volume XXI No. 11 – August 11, 2014 Issue

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 …

Clinical Labs Spending Money in New Ways

By Robert Michel | From the Volume XXI No. 4 – March 17, 2014 Issue

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…

Quality Assurance Regs to Tighten for UK Labs

By Robert Michel | From the Volume XXI No. 2 – February 3, 2014 Issue

CEO SUMMARY: In the United Kingdom, a window of opportunity has opened for improving the quality assurance activities of pathology and histopathology laboratories. Last week, at the Frontiers in Laboratory Medicine conference, the newly-published “Pathology Quality Assurance Review” w…

October 21, 2013 “Intelligence: Late Breaking Lab News”

By Robert Michel | From the Volume XX No.14 – October 21, 2013 Issue

There is progress on the integration of digital pathology systems and proprietary algorithms designed to help pathologists make diagnoses. This month, Visiopharm and Omnyx LLC, announced a joint venture. On its own, in Europe last year, Visiopharm earned a CE mark fo…

Volume XXVII No. 9 – June 22, 2020

THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.

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