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Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines.
J Low Genit Tract Dis
January 2025
Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD.
Objective: The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of extended genotyping results in cervical cancer prevention programs.
Methods: Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated using data obtained with the Onclarity HPV Assay from large cohorts. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines.
Application of Risk-Based Cancer Screening in Patients With Dermatomyositis.
JAMA Dermatol
November 2024
Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Public Perspectives on Direct-to-Consumer Testing Oversight.
Ther Innov Regul Sci
November 2024
School of Pharmacy, Temple University, Philadelphia, PA, USA.
The FDA published a final rule for Medical Devices; Laboratory Developed Tests in the Federal Register on May 6, 2024, which aims to ensure the safety and effectiveness of laboratory developed tests (LDTs) by amending current regulations. The rule also includes a policy to phase out the FDA's general enforcement discretion approach for LDTs, aligning them with other In Vitro Diagnostic Devices. Notably, direct-to-consumer (DTC) testing is exempt from this policy shift, as the FDA believes this category of tests has already met applicable requirements.
View Article and Find Full Text PDFComputing metrics to inform selection of candidate areas for a regionalized approach to bovine tuberculosis eradication in Ireland.
Vet Ital
June 2024
Centre for Veterinary Epidemiology and Risk Analysis, School of Veterinary Medicine, University College, Dublin.
We describe the computation of metrics to inform the selection of areas for a regionalised approach to bovine tuberculosis eradication in Ireland. Our aim was not to recommend suitable regions but to elucidate the criteria used in metric selection and comment on the diversity of metric values amongst regions. The 26 counties of Ireland were compared using 20 metrics, grouped into five categories: region size and cattle population, herd fragmentation, cattle movement, bovine TB testing, badger population and control.
View Article and Find Full Text PDFQuality control in the Netherlands; todays practices and starting points for guidance and future research.
Clin Chem Lab Med
October 2024
Department of Clinical Chemistry and Laboratory Medicine, Haaglanden Medisch Centrum, The Hague, The Netherlands.
Objectives: Adequate analytical quality of reported results is primarily ensured by performing internal quality control (iQC). Currently, several different iQC practices are in use. As a prelude to the revision of a Dutch guidance document on analytical QC, a questionnaire was sent out to gain insights in the applied practices and the need for guidance.
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