TAG:
COVID-19 serological tests
Predicting Future Demand for COVID-19 Testing
CEO SUMMARY: After 15 months of the pandemic, the nation’s clinical laboratories are at an interesting crossroads. Is the COVID-19 outbreak diminishing and close to disappearing? Or might it intensify again, particularly when the traditional influenza season arrives next fall? The…
What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22
CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…
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 XXIX, No. 10 – July 18, 2022
Theranos COO Ramesh “Sunny” Balwani has been found guilty of 12 counts of conspiracy and wire fraud, and The Dark Report examines his trial and compares it to that of CEO Elizabeth Holmes. Also, there are several important court rulings that will impact the way labs do business, as well as pending federal legislation to consider.
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