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clinical lab
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…
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…
Proscia Lands Major Deals as Digital Pathology Demand Grows
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
EVEN AS THE WORLDWIDE COVID-19 PANDEMIC DERAILED SOME INDUSTRIES, it gave a major boost to digital pathology. That has meant an expanding market for Proscia, a seven-year-old provider of digital and computational pathology solutions. Established in 2014, Proscia recently won …
CAP Loses CLIA Accreditation Clients to Joint Commission
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
This is an excerpt of a 1,790-word article in the January 19, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA …
2021 Opens with a Major Story … and It’s Not COVID!
By R. Lewis Dark | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
On the pages that follow, you will learn about a major story in the clinical laboratory…
CAP Loses Accreditation Clients to Joint Commission
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…
Why Are Health Systems Changing CLIA Accreditors?
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: It is uncommon for a major health system to switch its CLIA lab accreditation business from one accrediting body to another. Yet, just in the past 18 months, that decision was made by the Veterans Administration, Ascension Health, and Providence Health. This is an impor…
Understanding Differences Between 2 CLIA Accreditors
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
“We believe the ability to work with just two drops of blood, plus the…
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…
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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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