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COVID-19 Molecular Testing

Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome—the individual’s genetic code and how their cells express their genes as proteins—by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.

As the primary clinical manifestation of COVID-19 is a respiratory illness, PCR tests are generally used to test samples obtained from the upper or lower respiratory tract. Appropriate upper respiratory sample types include a nasopharyngeal swab or a throat swab.

Currently there are two types of diagnostic tests— molecular tests, such as RT-PCR tests, that detect the virus’s genetic material, and antigen tests that detect specific proteins from the virus.

Academic, Commercial Collaboration for Testing

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…

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January 19, 2021 Intelligence: Late-Breaking Lab News

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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Top 10 2020 Lab Stories Are about More than Just COVID-19

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…

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2020’s Top 10 Lab Stories Are Without Precedent!

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…

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OIG Says Medicare Spending On Testing Increased in 2019

CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…

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December 28, 2020 Intelligence: Late-Breaking Lab News

Seattle is the latest city to open walk-up kiosks for COVID-19 testing that allow individuals to collect their own saliva, then hand the specimen to a worker in the booth for overnight testing. Three such kiosks are now in operation. Curative, based in San Dimas, Calif., performs the testing u…

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NorDx Lab Started COVID Preparation in 2019

This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…

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Why Labs Operate in a ‘Duality’ during Pandemic

HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”?  On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…

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Memphis Path Lab Pivots to COVID, Pooled Testing

CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …

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NorDx Lab Started to Prepare for COVID-19 Testing in 2019

CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…

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