On 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.
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FDA’s final rule on LDTs: what does it mean for clinical laboratories?
On 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.
Current proteomics software compatibility for ZenoTOF 7600 system
Below is a summary of various other software packages that are useful for processing proteomics data from the ZenoTOF 7600 system. Note this list is not comprehensive and only covers the tools we have lightly tested to date. Acquisition Type Software Files needed...
Processing ZenoTOF 7600 system data with DIA-NN software
DIA-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 calculating averages or percent CVs from replicates in a 384 -well plate
This excel workbook is designed to be used with data copied from a SCIEX OS software Analytics module results file
Excel macro for plate building for transformation of 96-well to 384-well plates with generation of batch lists for SCIEX OS software
This 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
Uploading data for use in OneOmics suite
There are two options for data storage when working with the OneOmics suite. You can store your data either within the SCIEX Cloud platform in the Data Store, or you can store data in BaseSpace (Illumina) and link your BaseSpace account with the SCIEX Cloud platform....
How to download and use SVG files from OneOmics suite
Results workspaces in the OneOmics suite contain a variety of figures, all available for download as SVG (scalable vector graphic) files. To download your figures, select the orange arrow icon located in the upper right-hand corner of each plot. Download will...
CloudTalk – Review app for proteomics and metabolomics
This CloudTalk (6:57min) covers the basics of the Review app in the workspaces, for reviewing your multi-omics data in OneOmics suite. RUO-MKT-18-7017-A
sMRM Concurrency Calculator
This excel sheet allows you to quickly estimate the MRM concurrency and approximate dwell time for your Scheduled MRM Algorithm acquisition method. Paste your MRM method with retention times into the input tab then calculate the Excel workbook. Plots will update to...
Uploading and using transcriptomics data in the OneOmics suite
RNA experiments can be created in the OneOmics suite for multi-omics analyses, enabling integration of transcriptomics data and proteomics data for biological insight. To build RNA experiments, either CloudConnect for PeakView software 2.2 or BaseSpace (Illumina) can...
Merging two FASTA files
There is an easy way to merge two FASTA files together. Open notepad and type this string: type %*>"newfile.fasta" Enter any name for the FASTA file between the quotes. Save the file as: Merge FASTA files.bat Copy the two files you want to merge into the same...
Stay informed on the latest novel psychoactive substances (NPS) flooding the US drug market
Each year, the Drug Enforcement Administration (DEA) Special Testing and Research Laboratory publishes an Emerging Threat Report. The data contained in the report is updated quarterly and represents a snapshot of the drug evidence seized and analyzed by the DEA in the...
What is the difference between MRM3 vs MS/MS/MS (MS3)?
The MRM3 workflow and the MS3 scan are functionally the same QTRAP system scan, but used with different goals in mind. The main difference is how these scans are used in the whole MS workflow. With MS3 scans, you can use these in a data dependent mode for discovery...
What is the difference between a rapid and a thorough search in ProteinPilot software?
When setting up your search in ProteinPilot software, you select either a Rapid Search or a Thorough Search in the Search Effort section. This setting determines which parts of the algorithm will be invoked and effectively how deep into your sample you will search to...
Computing protein confidence with improved accuracy by reassessing peptide confidence during protein grouping
ProteinPilot software 4.0 and higher releases include a new method for calculating protein confidences that improves reliability at the end of protein lists. Figure 1 shows a simulated example that demonstrates how more accurate protein confidence is computed. Figure...
Breaking down the SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready
Sensitivity 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...
Importing acquisition methods from Analyst software to SCIEX OS software
The SCIEX Triple Quad 7500 system is the first nominal mass instrument to be released completely on SCIEX OS software. Moving to a new software solution can be time consuming with the need to transfer numerous methods to the new platform. SCIEX OS software helps...
A rising star in food allergen research: proteomics of shellfish allergen
It’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
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