TAG:
clinical laboratory industry
Officials Differ on Value of COVID-19 Pooled Testing
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 …
Why Local Labs Deserve More COVID-19 Supplies
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 t…
Government Officials Intensify Broad Chaos In Clinical Lab Supply Chain
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…
Labs Still Confront New Supply Shortages Daily
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…
July 13, 2020 Intelligence: Late-Breaking Lab News
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 C…
FDA Says 8 of 11 Tests Fail in Serology Test Review
This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail
CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from…
Health Insurers Push Back On COVID-19 Test Claims
CEO SUMMARY: Under new federal laws, health insurers are required to pay for testing for the novel coronavirus without cost-sharing, prior authorization, or medical management limits, but insurers are questioning these COVID-19 lab test bills and denying many of the claims, a healthca…
June 22, 2020 Intelligence: Late-Breaking Lab News
As they scramble to respond to the COVID-19 pandemic, federal officials in multiple agencies are purchasing equipment and supplies from vendors with dubious credentials and little operating history. In recent days, Pro-Publica reported “a fledgling Texas company was paid $7.3 mil…
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs
This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to man…
CURRENT ISSUE
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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