TAG:
COVID-19
Amazon Targets COVID-19 Testing in its New Lab-Building Venture
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 t…
COVID-19 Changes Lab and Pathology Profession
By R. Lewis Dark | From the Volume XXVII, No. 11 – August 3, 2020 Issue
WE ARE ENTERING THE SEVENTH MONTH OF THE SARS-COV-2 OUTBREAK and some public health authorities predict that new cases of COVID-19 will continue through the fall and into 2021. If true, this will not be auspicious for the nation’s clinical laboratories and anatomic pathology groups. The curren…
Amazon Building Labs to Do COVID-19 Testing
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medic…
In Just 13 Days, Lab Buys, Validates & Uses Analyzer
By Robert Michel | From the Volume XXVII, No. 11 – August 3, 2020 Issue
CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But beca…
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnos…
It’s a Clinical Lab Moment … But No Advocates!
By R. Lewis Dark | From the Volume XXVII No. 10 – July 13, 2020 Issue
Nearly every day since the onset of the SARS-C0V-2 outbreak, there have been stories in the national news about clinical laboratory testing for COVID-19. No laboratory professional alive today has seen such an endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime …
COVID-19 Pooled Testing: Good for Labs? Not IVDs?
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplie…
Officials Differ on Value of COVID-19 Pooled Testing
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare …
Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government…
Labs Still Confront New Supply Shortages Daily
By Robert Michel | From the Volume XXVII No. 10 – July 13, 2020 Issue
CEO SUMMARY: For three lab directors in the Midwest, a seemingly endless cycle of COVID-19 lab-supply shortages crops up almost daily. These labs might not have enough test kits one day, and be short of reagents, transport vials, or specimen collection swabs the next. To address these…
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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