FDA’s final rule on LDTs: what does it mean for clinical laboratories? by Pierre Negri | 0 CommentsOn April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
Easy switching of sources and LC flow regimes on the ZenoTOF 7600 system by Christie Hunter | 7 CommentsThis series of videos outlines how a user can easily switch sources and operate the system in different LC flow regimes.
Processing ZenoTOF 7600 system data with DIA-NN software by Christie Hunter | 0 CommentsDIA-NN software is a powerful software tool for processing data independent acquisition (DIA) proteomics datasets. It uses neural networks and other algorithms to identify and quantify peptides and proteins from DIA data and is specifically optimized for fast...
FDA’s final rule on LDTs: what does it mean for clinical laboratories? by Pierre Negri | Blogs, ClinicalOn April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
High mass tuning calibration for ZenoTOF 7600 by Gregg Czerwieniec | Bio Tool Kit, Development, Questions, ZenoTOF 7600 systemHi,
Easy switching of sources and LC flow regimes on the ZenoTOF 7600 system by Christie Hunter | Data acquisition, Ion sources, Life Science Research, Proteomics, SCIEX information, ZenoTOF 7600 systemThis series of videos outlines how a user can easily switch sources and operate the system in different LC flow regimes.
Processing ZenoTOF 7600 system data with DIA-NN software by Christie Hunter | Data processing, Life Science Research, Proteomics, SCIEX information, ZenoTOF 7600 systemDIA-NN software is a powerful software tool for processing data independent acquisition (DIA) proteomics datasets. It uses neural networks and other algorithms to identify and quantify peptides and proteins from DIA data and is specifically optimized for fast...
Excel macro for plate building for transformation of 96-well to 384-well plates with generation of batch lists for SCIEX OS software by Mackenzie Pearson | Bioanalysis/PK, Data acquisition, Echo MS, Pharma, Research (RUO), SCIEX informationThis macro-enabled workbook is designed to help with creating a formatted analysis list for the Echo® MS system, using 96-well plate maps or lists
Breaking down the SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready by Jianru Stahl-Zeng | Blogs, ClinicalSensitivity and robustness carry different meanings in the world of mass spectrometry. Generally, sensitivity refers to an instrument’s ability to achieve lower limits of detection (LOD). Robustness, on the other hand, refers to an instrument’s ability to consistently...
A rising star in food allergen research: proteomics of shellfish allergen by SCIEX Community | Blogs, Food / Beverage, Life Science Research, ProteomicsIt’s important to know what you’re eating, especially if you suffer from a food allergy. About 220 million people worldwide live with a food allergy.1 These numbers, along with the complexity and severity of conditions, continue to rise. In America, there are about 32 million food allergy sufferers—5.6 million of those are children under the age of 18.2.2 That’s 1 out of every 13 children, or about 2 in every classroom. From a financial perspective, the cost of food allergy childcare for US families is up to $25 billion