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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6 Signs it’s time for a new vendor
A lab’s success depends on many factors from instrument quality to efficient operations, including being partnered with the right vendor. A vendor is more than just a supplier. They should provide you with a high-level quality of support in maximizing the lifespan and performance of your systems, reducing downtime, enhancing ROI and more. How do you know if you’re partnered with the right one? Here are six signs it might be time to find someone new.
Nitrosamines: Where are we now?
Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.
Celebrating customer experience: Insights from SCIEX leaders
Introduction Customer Experience Day (CX Day) is a special occasion for SCIEX, celebrated every first Tuesday in October. It’s a day dedicated to recognizing the incredible value of our customers and the relentless dedication of our associates who strive to make...
PFAS analysis in food: a robustness study in sensitivity and stability
The combination of per- and polyfluoroalkyl substances (PFAS) testing, trace-level regulatory requirements and complex MS applications can be intimidating. In a recent webinar, now available on demand, SCIEX PFAS expert Craig Butt demonstrated how the new SCIEX 7500+ system can help make PFAS testing easier.
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
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.
Unlock the benefits of nominal mass spectrometry for NPS analysis
The development of analytical methods for the detection and quantitation of drugs and metabolites in a range of biological matrices is a challenging process. Forensic toxicology labs need a reproducible and reliable methodology to ensure the robustness of the data and the quality of the results. They also need robust and sensitive instrumentation that can detect drugs at trace levels with high specificity, especially when it comes to novel psychoactive substances (NPS), which can be difficult to monitor and control.
High mass tuning calibration for ZenoTOF 7600
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Metabolite identification and peace of mind
Managing metabolite identification (Met ID) studies is challenging, so what is at the top of your priority list as you plan the year ahead? Ensuring you have the data needed to manage product safety, meeting deadlines, staff recruitment and training, maintaining compliance, capital expenses, or something else?
Automation integration for the Echo® MS system
The Echo® MS system is specifically designed to be compatible with a variety of automation options to allow labs the flexibility to personalize their setup to meet their specific needs. To help you make the best decisions for your own lab, here are the answers to some...
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...
The top 5 questions to ask when investing in accurate mass technology for forensic toxicology workflows
Are you considering the purchase of a high-resolution accurate mass (HRAM) instrument for your forensic toxicology lab? To help ensure you invest in a solution that ideally meets your needs, ask yourself the following key questions. 1. How do I ensure my results...
Innovation that’s blasting through limitations in explosive detection
Mass spectrometry’s important role in identifying explosives The need for rapid explosive detection is now an unfortunate reality. The remit is multifaceted. The first is for preventative purposes, to protect us from any threat to life. The second is in the...
A new generation of therapeutic modalities
There are over 7,000 genetic diseases that could potentially be cured using gene therapy. Rare metabolic diseases, autoimmune disorders, cardiovascular disease and cancers are some of the top disease classes that can be addressed with gene therapies. With over 1,000...
Enhancing Biologics with CESI-MS Characterization
Comprehensive characterization of a biologic requires analysis at both the intact and digest levels, but these analyses can be complex and cumbersome. For example, with conventional liquid chromatography separations, researchers are often left with limited information...
Full, partial and empty capsid ratios for AAV analysis: What’s the big deal?
For many of you working to develop gene therapy drugs, you know that the time to market the drug is critical. Because gene therapeutics cure diseases by targeting specific genes, it is a constant race to see who develops the drug first. Unlike other classes of drugs where multiple medications can be used to treat a disease, whoever is first to develop a gene therapy drug wins.
Accurate mass LC-MS/MS for PFAS analysis without needing a blockbuster budget
If you’ve been following our recent blogs, you’ve probably seen quite a bit on how per- and polyfluoroalkyl substances (PFAS) are shaking up both the food and environmental industry. Even if you’ve not been following our blogs, you’ve probably seen a lot of media...
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
Routine cannabis screening is here. Will your lab reap the benefits?
Fast, accurate, and robust solution for routine commercial cannabis testing
As the world debates cannabis legalization for therapeutic applications and recreational use, the trends are shifting. Medicinal use of cannabis is legal in an increasing number of countries worldwide, including 33 states and the District of Columbia in the United States. Uruguay was the first country in the world to legalize the sale, cultivation, and distribution of cannabis in 2013. In the United States, Washington and Colorado were the first to fully legalize cannabis in 2012. By the end of 2019, 10 states have legalized recreational use for adults over the age of 21, with 64% of Americans favoring the move
Keep up with fentanyl and its analogs: Failure to do so is not an option.
Fentanyl is one of the most well-known synthetic opioids that has been in the spotlight lately—and not for good reasons. The World Drug Report 2019 reveals that there have been more than 47,000 opioid overdose deaths in the United States in 2017. This is an increase...
Hemp, marijuana, CBD and THC: what’s the difference?
Cannabis refers to a genus of flowering plants originating from Asia.1 It's also an umbrella term that includes both marijuana plants and hemp plants, among others. With the flurry of legalization across the United States, CBD and THC derived products have been thrown...
Mysterious Vaping Detectives Part 2
In our last blog, I gave you some current highlights about the mysterious vaping illness that was making headlines (and still is). The condition now known as, e-cigarette or vaping, product use-associated lung injury (EVALI) has sickened thousands and killed 57...
Trends shaping global environmental analytical testing
The only certainty in a changing environmental landscape Despite a 38-fold increase in environmental laws put in place around the world since 1972, the future of our planet is under the spotlight like never before. Mitigating climate change has arrived as our world's...
Mass spectrometry as a forensic science tool in 2020
There’s no doubt about it: forensics is at the front line of the criminal justice system. It’s where analytical chemistry has the power to fight crimes. It’s fascinating! But what excites me is how quickly things change and the speed of innovation. Just think about...
Microflow for metabolite ID: a win all around
Over the last several years there has been a slow and steady progression within the LC-MS community to move traditional high-flow applications to lower flow rates. In particular, moving into the microflow regime has proven to be a simple adjustment in methodology that...
A year of cannabis in Canada. Where are we and what’s next?
It’s been a momentous year for the cannabis industry in Canada. Not only did the country legalize cannabis with the Canadian cannabis law in October 2018, but it has also taken a giant leap in setting up a multi-billion dollar market from scratch. The progress made...
Take 5 with SCIEX Global Technical Marketing’s Pierre Negri
With the rise of Novel Psychoactive Substances (NPS), or designer drugs, in the past decade, forensic toxicologists are being tested like never before. It seems like as soon as one analog is identified, another is synthesized. These new chemicals share structures with...
When is a triple quadrupole not a triple quadrupole?
Answer: When it’s a QTRAP® In today’s modern and frenzied analytical laboratories, triple quadrupole mass spectrometers (MS) are the ‘workhorse,’ frontline instrument for carrying out quantitative assays from drug discovery to food safety. To get the best selectivity...
Turbo charging your LC-MS/MS analysis
Would you like to take your LC-MS/MS analysis from 0 to 3 mL/min without the complexity of changing probes or splitting the LC flow? Then take a look into the Turbo V ion source from SCIEX. Introduced more than 15 years ago, the Turbo V ion source continues to be a...
Separation anxiety: Choosing the best approach to quantify the lipidome
Front-End Solutions for Lipid AnalysisWhich method should you choose? Lipids are a diverse group of compounds that serve many purposes. They are the basis for key biological entities including cell membranes, hormones, and lipoproteins and are involved in a variety...