TAG:
analyzers
Many Questions About FDA Regulation of LDTs
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
September 13, 2010 “Intelligence: Late Breaking Lab News”
Researchers at North Carolina State University are developing a method that might make it possible to diagnose and treat cancer through the use of special microneedles they developed. NCSU researchers use the microneedles to deliver nanoscale dyes based on quantum dots to locations u…
2.3% Medical Device Tax Hits Clinical Labs in 2013
CEO SUMMARY: One aspect of the massive new health bill is that medical device companies will pay a 2.3% tax, effective January 1, 2013. Students of economics know that it is customers who invariably end up paying such direct taxes. Thus, clinical laboratories in the United States should p…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
2009’s Top Ten Lab Stories Reflect Some Good, Bad
CEO SUMMARY: As the closing year of the first decade of the new century and the new millennium, 2009 brought neither disruption nor upheaval to the majority of laboratories in the United States. Rather, it was marked by at least two themes. One was how public disclosure of problems with l…
Auckland Health Boards Give DML Some Testing
CEO SUMMARY: Auckland’s chaotic lab testing situation just became more complicated. Today the Auckland District Health Boards announced a four-year contract to allow Diagnostic Medlab to perform 10% of the area’s test volume, primarily for private hospitals and private specialists. It…
Expert Says Time is Now For Labs to Adopt QMS
CEO SUMMARY: Laboratories in the United States are knowledgeable about the use of quality control (QC) and quality assurance (QA) programs. But QC and QA represent only two small parts of a comprehensive quality management system (QMS), says Lucia Berte, an expert in lab quality. One bene…
Audacious Lab Contract Shows Downside Risks
CEO SUMMARY: In Auckland, New Zealand, unfolding events may soon reveal the answer to a long-standing question in pathology: is there a point where deep cuts to payment for lab testing causes such a decline in quality and service that other health services undergo disruption? Dis…
New Report: POC Market Will Grow 30% by 2013
CEO SUMMARY: It will be no surprise to lab directors and pathologists that Kalorama Information, in its latest report on point-of-care (POC) testing, estimates that glucose testing comprises 67% of this market segment. What is notable is Kalorama’s prediction that worldwide POC…
Why Wall Street Likes Histology Lab Business
CEO SUMMARY: Over the past two decades, investor-owned anatomic pathology companies captured significant market share from community hospital-based pathology groups while delivering profits to their owners. Despite the recent downturn in the economy, Wall Street believes histolog…
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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