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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 aĀ double-edged sword for clinical labs and in vitro diagnosticsĀ companies. Offering the advantage of reducing the number …
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs? Read More »
Nearly every day since the onset of the SARS-C0V-2 outbreak,Ā there have been stories in the national news about clinical laboratory testingĀ for COVID-19. No laboratory professional alive today has seen such anĀ 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, …
Itās a Clinical Lab Moment … But No Advocates! Read More »
CEO SUMMARY: Pooled testing for COVID-19 could be aĀ double-edged sword for clinical labs and in vitro diagnosticsĀ companies. Offering the advantage of reducing the number ofĀ standard tests for SARS-CoV-2, this testing method would cutĀ lab spending on tests and testing supplies, while conservingĀ standard non-pooled tests for symptomatic patients. But pooledĀ testing also could cut into test manufacturersā revenue, …
COVID-19 Pooled Testing: Good for Labs? Not IVDs? Read More »
CEO SUMMARY: Some experts on testing strategies supportĀ pooled testing because this method may support reopening byĀ schools and businesses and thus bring the economy back. ButĀ other experts have raised questions about this strategy. RulesĀ from the federal Centers for Medicare and Medicaid ServicesĀ say pooled testing is not diagnostic and so any lab can do theseĀ tests. But CMS …
Officials Differ on Value of COVID-19 Pooled Testing Read More »
CEO SUMMARY: As government officials and IVD firms divertĀ the lionās share of COVID-19 tests to a handful of billion-dollarĀ labs, in thousands of hospitals across the nation COVID-19Ā patients languish days longer before discharge because their hospitalĀ lab must send COVID-19 tests to outside labs and wait up toĀ seven days for results. Yet, those same hospital labs have …
CEO SUMMARY: Clinical labs throughout the United States areĀ ready to meet the challenges of the COVID-19 pandemic. At theĀ same time, there is widespread recognition that many barriers toĀ increasing labsā COVID-19 testing capacity are caused by the inappropriateĀ actions of government officials at all levels. This is particularlyĀ true of ongoing disruptions to the supply chain of the …
Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain Read More »
CEO SUMMARY: For three lab directors in the Midwest, aĀ seemingly endless cycle of COVID-19 lab-supply shortages cropsĀ up almost daily. These labs might not have enough test kits oneĀ day, and be short of reagents, transport vials, or specimen collectionĀ swabs the next. To address these problems, the lab directorsĀ have cobbled together a variety of solutions, but they …
On July 9, eight nationalĀ laboratory associationsĀ sent a letter to ViceĀ President Mike Pence toĀ request that the White HouseĀ Coronavirus Task ForceĀ take action to resolve majorĀ obstacles that constrain theĀ ability of their member laboratories to perform molecularĀ and serological tests forĀ COVID-19. Specifically, theĀ lab associations want actionĀ and resolution on supplyĀ chain issues. The letter notedĀ that āAt times, our membersĀ have even received faulty …
July 13, 2020 Intelligence: Late-Breaking Lab News Read More »
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