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analyzers
Value-based healthcare launches new conflicting interests for hospital labs, independents
By Mary Van Doren | From the Volume XXIV No. 16 – November 20, 2017 Issue
This is an excerpt from a 2,400-word article in the Nov. 20, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Her…
FDA Clears Waived CBC For Near-Patient Testing
By R. Lewis Dark | From the Volume XXIV No. 16 – November 20, 2017 Issue
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…
Paths of Hospital Labs, Independent Labs Diverge
By Robert Michel | From the Volume XXIV No. 16 – November 20, 2017 Issue
CEO SUMMARY: With each passing year, the primary role of hospital and health system labs evolves in a different direction than that of independent lab companies. This trend is a response to the creation of integrated delivery networks paid on value and how they are scored on their ability…
Lab Scheme Recruits Hospitals To Bill as In-Network Providers
By Joseph Burns | From the Volume XXIV No. 15 – October 30, 2017 Issue
CEO SUMMARY: Management companies using a new generation of potentially fraudulent schemes are targeting hospitals and health systems for arrangements that use questionable means to increase lab test volume and revenue. The management companies often use the term “hospital outpatient de…
New source of lab test abuse surfaces in the form of HOPDs and MSOs
By Mary Van Doren | From the Volume XXIV No. 15 – October 30, 2017 Issue
This is an excerpt from a 2,350-word article in the Oct. 30, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: …
Mass Spec Tests Struggle To Gain Insurers’ Attention
By Joseph Burns | From the Volume XXIV No. 9 – June 26, 2017 Issue
CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers …
What will the future hold for Theranos?
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
Theranos Now Scrambling To Save What It Can
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
Walgreens Tells Theranos: ‘Lab Deal Is Terminated’
By Robert Michel | From the Volume XXIII No. 8 – June 13, 2016 Issue
BREAKING NEWS: As this issue of THE DARK REPORT went to press, it was learned that Walgreens had announced the termination of its lab testing agreement with Theranos, effective immediately. Theranos loses access to about 40 Walgreens pharmacies in Phoe…
March 21, 2016 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXIII No. 4 – March 21, 2016 Issue
Tougher times in the clinical lab testing market have claimed another lab company. On February 28, Artherotech, Inc., posted a notice on its website stating that it had closed permanently, as of that date. Along with its several hundred employees, Artherotech’s closure caught many…
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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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