July 2020

Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number […]

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It’s a Clinical Lab Moment … But No Advocates!

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

Nearly every day since the onset of the SARS-C0V-2 outbreak, there have been stories in the national news about clinical laboratory testing for COVID-19. No laboratory professional alive today has seen such an endless stream of news stories about clinical lab testing. This is a once-in-a-lifetime event that could be quite favorable to the clinical lab profession. Unfortunately,

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COVID-19 Pooled Testing: Good for Labs? Not IVDs?

Clinical Laboratory / Robert Michel

CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number of standard tests for SARS-CoV-2, this testing method would cut lab spending on tests and testing supplies, while conserving standard non-pooled tests for symptomatic patients. But pooled testing also could cut into test manufacturers’ revenue,

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Officials Differ on Value of COVID-19 Pooled Testing

Clinical Laboratory / Robert Michel

CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare and Medicaid Services say pooled testing is not diagnostic and so any lab can do these tests. But CMS

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Why Local Labs Deserve More COVID-19 Supplies

Laboratory Equipment / Robert Michel

CEO SUMMARY: As government officials and IVD firms divert the lion’s share of COVID-19 tests to a handful of billion-dollar labs, in thousands of hospitals across the nation COVID-19 patients languish days longer before discharge because their hospital lab must send COVID-19 tests to outside labs and wait up to seven days for results. Yet, those same hospital labs have

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Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain

Clinical Laboratory / Robert Michel

CEO SUMMARY: Clinical labs throughout the United States are ready to meet the challenges of the COVID-19 pandemic. At the same time, there is widespread recognition that many barriers to increasing labs’ COVID-19 testing capacity are caused by the inappropriate actions of government officials at all levels. This is particularly true of ongoing disruptions to the supply chain of the

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Labs Still Confront New Supply Shortages Daily

Laboratory Equipment / Robert Michel

CEO SUMMARY: For three lab directors in the Midwest, a seemingly endless cycle of COVID-19 lab-supply shortages crops up almost daily. These labs might not have enough test kits one day, and be short of reagents, transport vials, or specimen collection swabs the next. To address these problems, the lab directors have cobbled together a variety of solutions, but they

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July 13, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

On July 9, eight national laboratory associations sent a letter to Vice President Mike Pence to request that the White House Coronavirus Task Force take action to resolve major obstacles that constrain the ability of their member laboratories to perform molecular and serological tests for COVID-19. Specifically, the lab associations want action and resolution on supply chain issues. The letter noted that “At times, our members have even received faulty

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