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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…
More Hospitals Now Use Point-of-Care Test Devices
CEO SUMMARY: Point-of-care testing (POCT) continues to gain acceptance in hospitals across the nation. One factor in this trend is improved technology for both the POC assays and the POC systems, each of which contributes to a more accurate and reproducible POC test result. But a…
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…
Geisinger’s Use of EHR Creates Opportunity for Lab to Add Value
CEO SUMMARY: Every health reform proposal makes it a high priority to implement a universal electronic medical record (EHR). Because lab test data is the essential component of a successful EHR, laboratory managers and pathologists may soon have a once-in-a-lifetime opportunity to use EHR…
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…
GSK and Abbott Team up For Companion Diagnostic
CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…
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…
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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