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Centers for Disease Control and Prevention

CLIA on Path to Recognize Lab Data As a Specimen

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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Eight Macro Trends for Clinical Labs in 2023

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…

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December 12, 2022, Intelligence: Late-Breaking Lab News

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…

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October 31, 2022, Intelligence: Late-Breaking Lab News

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…

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

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…

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September 19, 2022 Intelligence: Late-Breaking Lab News

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. …

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In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges

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…

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July 18, 2022 Intelligence: Late-Breaking Lab News

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…

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June 6, 2022 Intelligence: Late-Breaking Lab News

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…

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COVID-19: a Fork in the Road for Future Lab Testing?

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…

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