TAG:
laboratory-developed test
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…
Chicago Lab Launches LDT, Finds 20% Positive
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
CURRENT ISSUE
Volume XXVIII, No. 7 – May 24, 2021
The Dark Report is going on record on two trends that will impact clinical labs and pathology groups right in their wallets. The first trend is the potential for the COVID-19 pandemic to fade out, leaving labs without a large source of revenue. The second is the rise of ransomware attacks on healthcare providers, including labs. Details on both trends are included in this issue.
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