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. 12 – September 7, 2021
The Dark Report outlines the dangers to clinical labs and pathology groups posed by encryption attacks and their ransom demands, including steps an organization should take if attacked and how to prevent attacks. Also, a company developing image analysis software announced the acquisition of one of the nation’s largest independent anatomic pathology (AP) laboratories.
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