Issue: Volume XXVII No. 9 - June 22, 2020

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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, as of this writing …

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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 the market. Also, the FDA says 45 …

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Questions Arise as FDA Assesses Serology Tests

CEO SUMMARY: On June 4, the FDA released results of an evaluation of some of the 20 tests offered for sale in this country to identify antibodies for SARS-CoV-2. A quality control expert in clinical labs called the antibody test analysis deeply flawed in part because of the study’s design. The FDA evaluated serology assays  using 110 samples from …

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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 healthcare attorney said. Payers are challenging the medical necessity of COVID-19 tests, such as for patients needing surgery and …

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Lab Buys More Instruments as Way to Add Test Volume

CEO SUMMARY: Severe shortages of supplies for COVID-19 lab testing caused one lab director in the Midwest to buy additional instruments while also validating five different COVID-19 tests to run on analyzers the lab used before the pandemic hit. While this strategy allowed the lab to bump up the number of COVID-19 tests it can perform daily, ongoing shortages of …

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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 million for test tubes needed in tracking the spread of the coronavirus nationwide. But, instead of the standard vials, Fillakit LLC has supplied plastic tubes made for bottling soda, which state …

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