TAG:
COVID-19
What’s Ahead for Labs? It’ll Be Quite Different
CEO SUMMARY: In many ways, the nation’s clinical laboratories performed magnificently in response to the SARS-CoV-2 outbreak last winter. But that magnificent performance has taken its toll on the infrastructure and personnel within these labs. The Dark Report…
Academic, Commercial Collaboration for Testing
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, t…
SARS-CoV-2 Variant Sequencing Creates New Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
This is an excerpt of a 2,964-word article in the February 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants wil…
Critics Say New At-Home Test Is Expensive and Late to Market
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
ONCE AGAIN, THE COMBINATION of the pandemic and the federal government may be creating a credible new competitor in the in vitro diagnostics (IVD) industry. This time, the lucky company is Ellume, which was just awarded $231.8 million from the Biden administration to s…
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
January 19, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…
Top 10 2020 Lab Stories Are about More than Just COVID-19
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
Managing Labs in Two Dimensions in 2021
By R. Lewis Dark | From the Volume XXVII, No. 18 – December 28, 2020 Issue
EXPECT 2021 TO BE JUST AS CHALLENGING A YEAR for lab management as was 2020. This will be true not only because of the SARS-CoV-2 pandemic. Other important factors will complicate the operation of clinical laboratories and anatomic pathology groups in the new year….
2020’s Top 10 Lab Stories Are Without Precedent!
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day. …
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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