TAG:
hematology tests
FDA Clears Waived CBC For Near-Patient Testing
CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…
Office-Based Physicians Want In-Clinic Laboratories
CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…
Key Trends Drive Change for Clinical Laboratories
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
Lab Competitors Pool Lab Data For Clinicians In British Columbia
CEO SUMMARY: In British Columbia, two commercial laboratory competitors have found common ground. BC Biomedical Laboratories and MDS Metro Laboratories are using LOINC to link their laboratory test databases. Physicians use a single system to access their patient’s test results, regardl…
United Kingdom Soon to Tackle Consolidation of Hospital Labs
CEO SUMMARY: Consolidation and regionalization of hospital laboratory testing are not isolated phenomenons. Beginning in the late 1980s, individual provinces in Canada began to rationalize lab testing services by building core labs and consolidating lab services across multiple hospitals….
“State of Lab Industry” Holds Surprises for All
CEO SUMMARY: Say goodbye to several of the trends which shaped the lab industry during the 1990s, such as consolidation and government compliance programs. Although these trends won’t completely disappear, they will be superseded by a number of new transformational influences. During th…
Abbott, CARESIDE, Bio-Reference Labs, DIANON Systems
SWARM OF LAWSUITS NOW PLAGUES ABBOTT LABS PAYING A $100 MILLION FINE TO THE Food and Drug Administration (FDA) did not end Abbott Laboratories, Inc.’s problems related to its diagnostic test kits and reagents. Since payment of the FDA fine last month, Abbott has been serv…
1999’s Top Ten Stories Reflect Speed of Change
CEO SUMMARY: This year’s round-up of the lab industry’s Top Ten most important stories lacks any compelling single theme. THE DARK REPORT’s conclusion? 1999 was a transition year. No new outside forces rattled the lab industry, allowing lab executives and pathologists to concentrate…
Opening Pandora’s Box
OUR EDITOR ONCE AGAIN HAS ANOTHER REMARKABLE PREDICTION for the clinical laboratory industry. In this issue, he predicts new point-of-care (POC) technology for routine chemistry and hematology testing will start the long- foretold process of laboratory decentralization. This follows on the heels of t…
Point-Of-Care Chemistry Ready To Transform Labs
CEO SUMMARY: Following on the heels of our prediction about web-based test ordering/results reporting, here’s another equally revolutionary development. CARESIDE, Inc. is ready to launch a point-of-care instrument suite for routine, high-volume chemistry and hematology tests. Early peek…
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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