Tag: ivd manufacturer

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 of point-of-care testing systems. Hospitals and clinical laboratories buying POC products from Abbott and

View Article

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 laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for

View Article

Benchmarking with the Best To Be a World Class Laboratory

laboratory management pyramid levels level 4

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 delivering substantial measurable value to all stakeholders and it will have the metrics to substantiate this value. At the same time, the performance of a level four lab can be validated by its use of recognized third-party benchmarks that show it is performing equal to the best labs in the United States and across the globe. It will also have customer survey data showing it meets and exceeds its customers’ expectations.

View Article

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 neonatal and prenatal screening along with infectious disease testing. PE’s new venture hopes to leverage relationships developed from providing newborn and prenatal screening in China throughout for the past 20 years.

View Article

Quality Assurance Regs to Tighten for UK Labs

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” was the focus of several keynote sessions. One recommendation is to develop key assurance indicators (KAIs) that

View Article