Tags

  • Sorting

  • Filters

Overcoming uncertainty in your PFAS analysis

Just like gum on the bottom of a shoe, the existence of per- and poly-fluorinated alkyl substances (PFAS) in our environment is a sticky one. If you’re in the field of environmental testing, then you’re all too familiar with the threat these substances have on public health. While we have learned a lot about them over the years, there is still much more to understand. With the right detection methods, we can gather the information we need to empower us to make informed decisions on reducing the risks they impose.

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.

LC-MS system replacement: Are you ready?

Meeting deadlines in a bioanalysis laboratory can be a big challenge. Older, less sensitive and less reliable LC-MS systems make it even more difficult. Even the disruption caused by the installation and validation can be disconcerting and delay decisions. Does this sound familiar?

Overcoming uncertainty in your PFAS analysis

Overcoming uncertainty in your PFAS analysis

Just like gum on the bottom of a shoe, the existence of per- and poly-fluorinated alkyl substances (PFAS) in our environment is a sticky one. If you’re in the field of environmental testing, then you’re all too familiar with the threat these substances have on public health. While we have learned a lot about them over the years, there is still much more to understand. With the right detection methods, we can gather the information we need to empower us to make informed decisions on reducing the risks they impose.

FDA’s final rule on LDTs: what does it mean for clinical laboratories?

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.

Guide decisions during cell line development with more information at the intact level

Guide decisions during cell line development with more information at the intact level

Monitoring product quality attributes (PQAs) throughout monoclonal antibody (mAb) development is vital to ensuring drug safety and efficacy. By adopting orthogonal analytical techniques and integrating new technologies that have the potential to provide more information, it is possible to improve product quality and manufacturing efficiency and make more informed decisions.

What has the Echo® MS system done for the pharma industry? (And don’t just take our word for it!)

What has the Echo® MS system done for the pharma industry? (And don’t just take our word for it!)

SCIEX was very proud to have an illustration of the Acoustic Ejection Mass Spectrometry (AEMS) technology that powers the Echo® MS system on the front cover of the Journal of the American Society for Mass Spectrometry in January 2023. The associated article—Ultrahigh-Throughput Intact Protein Analysis with Acoustic Ejection Mass Spectrometry—was co-authored by scientists from SCIEX and Merck.

How do I define the experimental design (the metadata) for my SWATH acquisition study within the OneOmics suite? What are the requirement for replicates?

How do I define the experimental design (the metadata) for my SWATH acquisition study within the OneOmics suite? What are the requirement for replicates?

In quantitative Omics research, the goal is to understand which analytes (protein or metabolite) are perturbed between experimental conditions; therefore we carefully design our studies to explore these questions. The algorithms used within the Assembler application...

The risky business of aflatoxins in milk

The risky business of aflatoxins in milk

If you’re in the dairy or food testing business, you know the threat aflatoxins pose. Aflatoxins are a type of mycotoxin produced by Aspergillus parasiticus, aspergillus flavus , and rarely aspergillus nomius.1 These are likely the most extensively researched group of mycotoxins because of their adverse health effects.2 What’s more, they are widely found in a variety of crops, namely maize, tree nuts, and spices. Believed to be primarily caused by rising temperatures and humidity, these naturally occurring fungi grow on crops in the field, or during storage of feed and raw materials, where they can potentially produce toxins that enter the food chain.

The honey sting

The honey sting

As a consumer it’s hard for me not to feel inundated with claims that our food is “all-natural” or “chemical-free” or that we should buy certain “superfoods” for their health benefits.  We read labels and trust that the product we are buying is what we are truly...

A rising star in food allergen research: proteomics of shellfish allergen

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

Detect the Signal, Not the Noise

Detect the Signal, Not the Noise

  Improving the specificity and selectivity of your assay Your LC-MS assay is only as good as its power to discern your target compound from everything else. Standards dissolved in clean solvents can make beautiful assays, but analytes in real-world samples can behave...

Make the Leap from GC to LC-MS/MS

  Choosing the best technique for your analysis can be tough. Should you go with gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS)? That’s the key question. That’s why we’re here to help. The Limitations of...

Uncovering the Links Between Childhood Growth, Body Size, and a Woman’s Risk of Breast Cancer

Uncovering the Links Between Childhood Growth, Body Size, and a Woman’s Risk of Breast Cancer

Welcome to the second in a series of posts marking International Women’s Day, and our ongoing support of World Cancer Research Fund. This installment is a review by Dr. Jennifer Baker, of her work, that, with the help of a WCRF grant, is studying body size and its links to breast cancer. Dr. Baker, Lead Investigator at Denmark’s Frederiksberg Hospital, has a Ph.D. in Human Nutrition from Cornell University. Her research focuses on clinical epidemiology.

Wordpress Social Share Plugin powered by Ultimatelysocial