TAG:
clinical trials
Alberta Picks Sonic Health for $3 Billion Lab Contract
CEO SUMMARY: For more than a year, Alberta’s C$3 billion RFP to develop an integrated laboratory testing service for Edmonton and surrounding regions has been the focus of intense interest. On October 17, health officials announced that Sonic Healthcare Limited was the preferred propone…
Dealing with Realities of Changing Market
CEO SUMMARY: Swift transformation of the American healthcare system is causing financial challenges for those clinical labs and pathology groups that have been slow to react to these developments. At NorDx Laboratories in Scarborough, Maine, the team is following the classic five rules fo…
UCLA, Centre to Open Lab in China to Offer High Quality Testing
CEO SUMMARY: To fill the unmet demand for quality clinical laboratory testing in China, a partnership between pathologists at UCLA and Centre Testing International Corp. of Shenzen have built and will operate a lab facility in Shanghai. The new lab will open by late September and…
UCLA Pathologists to Open Joint Venture Lab in Shanghai
PATHOLOGISTS at the University of California Los Angeles Department of Pathology will participate in a unique commercial laboratory company that will be based in Shanghai, China. On April 8, UCLA announced a partnership agreement with Centre Testing International Corp….
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
Lab Companies’ IPOs Go Two-for-Three in November
CEO SUMMARY: This fall, a parade of molecular and genetic test companies moved forward with initial public offerings (IPOs) of their stock. In September, Foundation Medicine raised $106 million from its IPO. Encouraged by this success, three different companies proceeded with IPOs during …
Newsmaker Interview: Adam Slone, Tara Kochis
“When it comes to hiring senior leaders, labs today are more diligent in recruiting and interviewing candidates for key executive and management positions. One reason for this change is the shrinking financial margins at most labs.” …
Pathologists in China, U.S. Linked By Digital Pathology
CEO Summary: It is one of the first clinical collaborations of this type to be anchored by use of digital pathology. Pathologists at the medical schools of the Second Affiliated Hospital of Zhejiang University in Hangzhou, China, and the University of California Los Angeles (UCLA) are exc…
Ohio Lab Offers Lessons Learned from CAP 15189
CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohi…
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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