TAG:
Centers for Disease Control and Prevention
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…
September 19, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 13 – September 19, 2022 Issue
Déjà vu? Lawmakers in Congress question whether public health officials have done enough to stay ahead of monkeypox, including the availability of diagnostic tests. Concerns about such testing came up during a Sept. 14 hearing before the Senate’s Health, Education, Labor, and Pensions Committee. …
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…
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…
Paige’s Digital AI Tool Aids in Prostate Cancer Diagnosis
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Study data provided to the FDA “demonstrated increased diagnostic accuracy” when pathologists used the Paige Prostate system, said Paige’s Medical Director. The artificial intelligence-powered pathology image analysis tool is trained to help pathologists detect ev…
Executive War College to Show New Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Yes, the pandemic continues and hospitals are running short of beds in many communities. At the same time, 225 million Americans are either vaccinated or have some immunity to COVID-19. Based on the early registrations to attend the 27th annual Executive War College, it…
Are Live Lab Industry Conferences Returning?
By R. Lewis Dark | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
For several months, many of you have used conversations and email to encourage us to conduct a live Executive War College before the end of 2021. It was because of this support that we arranged a hotel in a state that has supported a return to more normal activities. Thus, our conference will …
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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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