TAG:
in vitro diagnostic
A Common Future for Pathology & Radiology?
DO RADIOLOGISTS AND PATHOLOGISTS have a common future in the age of personalized medicine? That’s not an idle question as new technologies help both medical specialties to better understand how molecular processes play a role in various diseases. Oncology may prove to be the powerful force that en…
LabCorp’s Ovarian Cancer Test Generates FDA Warning Letter
WHEN THE FOOD AND DRUG ADMINISTRATION (FDA) sent Laboratory Corporation of America a letter in September declaring its marketing of the Ovasure test for ovarian cancer was a violation of the law, the news was widely reported. Because Ovasure is a test that is being …
Quality Management Systems (QMS) & Healthcare
OFF THE RADAR SCREEN OF THE LABORATORY INDUSTRY is an evolving management approach that gives unity to the mishmash of quality improvement tools that carry a variety of names, but have several common attributes. Soon lab directors and pathologists will be quite familiar with the concept of the “qu…
NY & Calif. Act to Stop Web Gene Testing Firms
CEO SUMMARY: Events in the past month indicate that a war is developing between Internet-based companies offering genetic tests to consumers and state and federal health regulators. New York state authorities have sent letters to at least 31 such companies in recent month…
June 16, 2008 “Intelligence: Late Breaking Lab News”
GE Healthcare’s digital pathology joint venture with the University of Pittsburgh Medical Center (UPMC), announced on June 5, is not the only in vitro diagnostics (IVD) investment by GE during 2008. Just this May, GE paid $738 million to acquire …
ISO 15189 Work Advances at Meeting in Vancouver
CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standard…
GE, UPMC Create Company for Digital Path Imaging
CEO SUMMARY: It’s a new joint venture with the potential to transform surgical pathology. General Electric Healthcare has extensive experience at supporting physicians’ work flow with digitized imaging systems, plus ample experience with molecular bio-markers. The University of Pittsb…
Lab Automation Advocates Gather in Kobe, Japan
CEO SUMMARY: Everything relating to automation in clinical laboratory operations was the theme of the sixth “International Conference of Laboratory Automation and Robotics,” conducted last month in Kobe, Japan. Because laboratories in Japan, Korea, and Taiwan have two and three decade…
Heparin, China, Reagents, and Your Lab
MANY OF YOU HAVE HEARD THE NEWS about the contaminant that was found in the heparin manufactured and sold by Baxter International, Inc. Authorities, responding last fall to reports of hundreds of bad reactions and 19 deaths to the drug, quickly focused on the Chinese companies that s…
Ascendium Consulting Is New Firm In Lab Market
CEO SUMMARY: Growing numbers of laboratories are taking steps to reengineer work flow, evaluate automation solutions, and improve the operational performance of their laboratory. This is fueling a demand for laboratory consulting services and Ascendium Consulting is this newest healthcare…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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