Help Us to Help You: Recommendations for Continued Enforcement Discretion for Common Infectious Disease Test Modifications under the FDA Final Rule

Raymond Nistor-Gallo, Kurt Zatloukal, Karin Schwenoha. Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures. Clinical Chemistry, Volume 71, Issue 12, December 2025, Pages 1202–1211. https://doi.org/10.1093/clinchem/hvaf123

Vrajesh Pandya. Transdermal GFR Signals a New Horizon in Renal Diagnostics. Clinical Chemistry, Volume 71, Issue 12, December 2025, Pages 1281–1282. https://doi.org/10.1093/clinchem/hvaf106

Jeffrey W Meeusen, Xin Yi, Steven W Cotten, Jacob B Nielsen, Leslie J Donato, Patricia M Jones, Alagar R Muthukumar, Rafael Zubirán, Alan T Remaley, Jing Cao, Modern Low-Density Lipoprotein Cholesterol Formulas Outperform Direct Methods in Patients with Hypertriglyceridemia and Low Levels of Low-Density Lipoprotein Cholesterol, Clinical Chemistry, Volume 71, Issue 11, November 2025, Pages 1138–1146, https://doi.org/10.1093/clinchem/hvaf099

Ruben Y Luo, Priscilla S W Yeung, Morgan W Mann, Lichao Zhang, Yifei K Yang, Andrew N Hoofnagle, Post-Translationally Modified Proteoforms as Biomarkers: From Discovery to Clinical Use, Clinical Chemistry, Volume 71, Issue 11, November 2025, Pages 1111–1124, https://doi.org/10.1093/clinchem/hvaf094

Nicholas C Spies, Embracing Generative Artificial Intelligence as a Support Tool for Clinical Decision-Making, Clinical Chemistry, Volume 71, Issue 11, November 2025, Pages 1178–1179, https://doi.org/10.1093/clinchem/hvaf084