TAG:
COVID-19 serological tests
Thermo–Qaigen Merger Stopped, More IVDs Report Q2 Earnings
EACH TIME A MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANY reports its quarterly earnings, clinical lab executives and pathologists gain useful new perspectives as to how the COVID-19 pandemic is fueling demand for IVD instruments, tests, and lab consumables. In this round-up of the most r…
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,…
Where Is the FDA When Labs Need It Most?
LET’S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to tha…
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…
CURRENT ISSUE
Volume XXVII, No. 14 – October 5, 2020
THE DARK REPORT HAS ANALYSIS showing potential reasons why the Department of Justice has generated its largest lab fraud crackdown in history. $6B in allegedly fraudulent claims and 345 defendants may well be the result of an explosion in molecular test claims in 2019. Also, another competitor has entered the lab marketplace, this time with portable COVID-19 testing labs in trailers.
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