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Bench Matters

The Skinny on Lipid Reporting
Lipid testing is a cornerstone in atherosclerosis and cardiovascular disease (ASCVD) risk assessment. While there are several comprehensive clinical guidelines that focus on the primary prevention of ASCVD, guidance for the clinical lab remains limited. This causes significant variability in the way lipid testing is reported.
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Federal Insider

FDA Must Improve EUA Process, Federal Investigators Say
The Food and Drug Administration’s use of emergency use authorizations in the early part of the COVID-19 pandemic came at a cost to quality, but the agency’s experience during the pandemic offers lessons the government needs to learn from, according to a report by the Department of Health and Human…
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Industry Playbook

Regulatory Roundup

Early Cervical Cancer Test Approved in China
Developed by the German company oncgnostics, the cervical cancer screening test, GynTectis, is the first methylation assay for triage of human papillomavirus (HPV)-positive cases that the Chinese National Medical Products Administration has approved.
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Special Supplement

The Sample