TAG:
LDTs
NorDx Lab Started COVID Preparation in 2019
This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…
NorDx Lab Started to Prepare for COVID-19 Testing in 2019
CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…
October 26, 2020 Intelligence: Late-Breaking Lab News
In Houston, an 18-year-old high school student started a mobile laboratory company to provide COVID-19 tests to home-bound patients. As the youngest emergency medical technician in Texas, Taft Foley, III, saw the need for this service. Texas Mobile Medical Labs is the name of his company a…
FDA Replaces March 16 Serology COVID-19 Rules
CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la…
March 30, 2020 Intelligence: Late-Breaking Lab News
Should consumers be allowed to collect their own specimens for a COVID-19 test? At least five companies announced plans in mid-March to sell COVID-19 tests directly to consumers and have them collect their specimens at home, then return the samples to the the labs doing the testing. This s…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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