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CDC
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
December 12, 2022, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 17 – December 12, 2022 Issue
Is it time to allow consumers to do at-home testing for influenza? Given the already-raging influenza season—flu-related hospitalizations doubled the week of Nov. 20 compared to a week earlier, according to the Centers for Disease Control and Prevention—the STAT medical news site ra…
October 31, 2022, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 15 – October 31, 2022 Issue
Clinical laboratories may soon face increasing pressure to test for respiratory syncytial virus (RSV) now that the public has become aware of the pathogen. Over the past month, there has been an onslaught of media attention on RSV. The coverage has often focused on how this common virus could tag…
Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More
By Robert Michel | From the Volume XXIX, No. 15 – October 31, 2022 Issue
CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…
In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have t…
July 18, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
Given that monkeypox cases continue to rise, the federal government likewise is ramping up its response. In June, the federal Centers for Disease Control and Prevention (CDC) began shipping monkeypox tests to five commercial laboratories: Aegis Science, Labcorp, Mayo Clinic La…
June 6, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue
Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possib…
Decline in COVID-19 Test Orders Signals a Shift
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
MIGHT THE FEDERAL HEALTHCARE ESTABLISHMENT BE CLOSE TO DECLARING AN END TO THE SARS-COV2 PANDEMIC and—given the ongoing decline in the daily number of new cases and deaths—that COVID-19 is expected to become an endemic disease? The SARS-CoV-2 statis…
COVID-19: a Fork in the Road for Future Lab Testing?
By R. Lewis Dark | From the Volume XXIX, No. 4 – March 14, 2022 Issue
We have all experienced a pandemic unique in the history of the world. Two elements, in particular, distinguished this pandemic from earlier global outbreaks. First, genetic technologies allowed scientists to almost instantly sequence the DNA of the novel coronavirus, once it was recognized as a uniq…
It’s Flu Season and COVID-19 Cases Continue
By R. Lewis Dark | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….
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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