In the first article in this series, we looked at how HMGB1 has taken an increasingly important position as a key mediator in the immune response, playing a major role in many diseases, from cancer to coronavirus. There is now significant evidence that HMGB1 is essential for SARS-COV-2 replication, as well as potentially being a therapeutic target in severe cases of COVID-19.1 In this article we examine how we can effectively measure HMGB1 accurately in serum and other samples and begin the journey from research to clinic.
How the human body deals with infection depends on an individual’s immune response. When looking at the body’s response to SARS-CoV-2, the state of the immune system has a crucial impact on the clinical outcome. For example, HMGB1 (High Mobility Group Box 1) protein is a key mediator of the immune system, and as such it has been shown to be critical in the replication of SARS-CoV-2. This article outlines the potential roles of HMGB1 in the race to find solutions to the coronavirus pandemic.
With complex products like laboratory instruments used to automate genomic testing, time to market is often a critical factor in determining whether or not to go ahead with product development. The obvious problem is that as projects become more complex and involve more teams with mixed competencies, calculating the time to market becomes more challenging. Based on my experience, here are some of the top reasons why companies significantly underestimate their time to market projections. If you can avoid these common pitfalls when launching new lab instruments and genomic tools, then the risk of your project being delayed is significantly reduced.
The accurate measurement of female hormone levels is at the very core of women’s reproductive health and general wellbeing, whether searching for potential causes of infertility, or treating debilitating premenstrual or menopausal symptoms. These tests were traditionally blood-based. However, saliva-based testing is now recognized as a highly accurate and painless alternative. In our final article in this series, we examine some of the different saliva-based testing technologies and protocols available for measuring and monitoring female hormone imbalance.
The COVID-19 pandemic has forced everyone to look at laboratory routines to see if they are really pandemic proof. For example, the explosive demand for high throughput genomic analysis often creates pressures upstream to process many more samples and prepare high quality DNA. The rapid shut down of non-essential workplaces and services coupled with the surge in demand for laboratory testing put immense strain on multiple aspects of normal laboratory operations such as strict rules on the need for personal protective equipment which was in limited supply and required physical distancing. Consumable stocks and reagents also dwindled as they were being used at a much faster rate and the supply chains were affected by global demand. Now that limitations of current laboratory routines have been highlighted, it’s time to consider how to make laboratories pandemic proof.
Designing and manufacturing lab instruments that include automated liquid handling is challenging at the best of times, but in the face of increased demand for faster testing, it’s even more critical to select the right partner and reliable components. The global COVID-19 pandemic is posing unprecedented challenges for laboratories as they race to meet the demand for accurate, large-scale testing in a short amount of time, and without the risk of cross-contamination.
Saliva-based tests are a reliable and proven method for measuring female hormone levels, as well as being highly accurate and painless for the patient.¹ This article takes you through five key steps to consider when setting up saliva-based testing for measuring and monitoring female hormone imbalance.
How do you prepare for the unexpected? The COVID-19 pandemic has brought to light how challenging it is for labs and production facilities to scale up quickly in times of need. The sudden surge in demand for laboratory solutions at the very time that we are experiencing unprecedented constraints on the workforce and global supply chains is a wake-up call. This has put pressure on infrastructures in every sphere connected to the healthcare industry—from R&D and manufacturing to clinical diagnostics. Even relatively small labs and organizations have been required to rapidly shift focus and massively expand their outputs at an unprecedented rate.
There is, however, a silver lining: the current pandemic compels healthcare industry leaders to question the agility and scalability of their laboratory solutions—both now and in the future. With the advent of next-generation sequencing (NGS), the field of metagenomics has exploded in recent years, as scientists are now able to study microbes as communities instead of individual organisms. This has revolutionized our understanding of the relationships between microbiota, human health, and the environment.
Steroid analysis using a saliva sample first appeared in the scientific literature more than 40 years ago.1 Now, as then, saliva sampling presents an attractive alternative to blood testing because it is non-invasive, easily repeatable, can be performed in settings that may not be conducive to blood sampling, and is less stressful and more convenient for patients.
From top global instrument makers to smaller startups, life science companies face a challenge when developing and launching new IVD products in a fast-paced market. How do you create a product that meets market needs without overdeveloping it? You want a development effort that keeps costs in a profitable range while still delivering value to your customers. And you want to launch your new product within a window of time that makes it unique on the market.
Female hormone levels have been measured using blood tests for decades.1 However, blood sampling is costly, invasive, and often logistically difficult, so there is a shift towards the adoption of tests based on more convenient and cost-efficient sample types, such as saliva. Saliva-based tests are considered a reliable and proven method for measuring female hormone levels, as well as being highly accurate and painless for the patient.1 In this blog series, we look at how saliva testing for female hormone imbalance is changing the clinical diagnostics landscape, and positively impacting women’s health across the globe.
There is a definite role for IgG4 testing when diagnosing and treating pathologies that are associated with elevated levels of specific IgGs, such as Crohn’s disease, ulcerative colitis and irritable bowel syndrome.¹,² This is despite the fact that IgG4 testing has had a lot of bad press over the years, mainly because it has been shown that elevated IgG4 levels for certain food antigens may simply be an indicator of exposure and tolerance of a specific food, rather than an indicator of “true” food intolerance.³ With that in mind, we look here both at the science behind the tests, and the evolving IgG and IgG4 ELISA testing market.
Women are affected by the ever-changing levels of their female sex hormones throughout all stages of their lives. These fluctuations may be normal or abnormal and may affect the development of a young woman’s secondary sexual characteristics, menstrual cycling and associated disorders, pregnancy and infertility issues, cardiovascular and bone health, and perimenopausal and menopausal symptoms. Saliva hormone testing is easy to do and is often the first step in diagnosing and better understanding the cause of a variety of women’s health problems. Saliva testing is a simple and noninvasive method of measuring female hormones that offers advantages over traditional blood testing as a female hormone imbalance test.
Food intolerance or sensitivity to many common foods, such as gluten, dairy or other products, appears to be on the increase. This begs the question: does food intolerance really exist, or is it simply a trendy fad in today’s health-conscious society? In this new blog series we start by reviewing the science behind food intolerance, outline its potential causes, and investigate how it could be reliably diagnosed and treated using IgG-based tests such as ELISA.
If you’re thinking about automating your in vitro diagnostic (IVD) product it can be hard to decide whether to outsource to an Original Equipment Manufacturing (OEM) partner or keep the development in-house. While the familiarity of a DIY solution might be appealing there are a number of hidden pitfalls that could hamper your progress.
Finding the right OEM partner for your IVD medical device could give you the edge by avoiding these pitfalls and giving your project a speed and performance boost needed to help you get to market faster.
Introducing a new in-vitro diagnostics (IVD) lab automation solution can add an entirely new dimension to your existing product portfolio and business. Launching a complete system that provides harmony between chemistry and assay workflow, instrumentation, software analysis and reporting is a complex endeavor that demands careful planning and execution.
Generating reproducible, accurate ELISA data starts with reliable reagents that are highly sensitive and specific. These are often available as kits that need to be incorporated into an efficient workflow. Unfortunately, running ELISA manually involves multiple manual wash processes and pipetting steps that are time-consuming, increase the risk for human error, and lead to poor reproducibility. Automation is the best route to smoothening the workflow and increasing data reliability.
With more than 50% of preclinical results estimated to be irreproducible, the reliability of methods, assays, and protocols is a major concern in all areas of research. Many critical assay workflows, such as those for ELISA tests, are prone to error, even when using a high quality kit. While ELISA kits provide a solid basis to generate reliable data, troubleshooting the complete assay workflow is the first step toward pinpointing additional sources of variability and error that must be addressed in order to increase reproducibility and confident decision making.
It can be easy to dismiss outsourcing lab automation in favour of seemingly less expensive do-it-yourself (DIY) solutions. However, outsourcing is more cost effective than it might seem. By taking advantage of the expertise of Original Equipment Manufacturing (OEM) partners, who can also offer a variety of flexible financing options, outsourcing could well be the right solution for your business. Here are some of the main ways in which OEM partners can make your automation project more cost-effective.
With open source software and high quality off-the-shelf components, do-it-yourself (DIY) lab automation solutions are trending. While developing lab automation in-house might seem attractive at first glance, the road is littered with hidden pitfalls that can derail internal projects. Finding an Original Equipment Manufacturing (OEM) partner can be a cost-effective way to circumvent the pitfalls and mitigate risks by working with a trusted automation expert.
As a diagnostic product moves through its lifecycle, its development, engineering and customer support needs change. In order to extend the period of product profitability and customer loyalty for as long as possible, you must start planning for the next evolution of the product from the beginning. Involving an OEM partner in your product lifecycle management (LCM) from the start can help you create products that are easier to service at a lower cost and with fewer long-term risks.
The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe’s new In Vitro Diagnostic Regulation (IVDR 2017/746), it’s crucial that diagnostics businesses critically evaluate their entire supply chain to close any gaps and ensure IVDR-compliance can be maintained throughout the device lifecycle. An important question to ask is whether outsourcing your IVD projects will help or hinder your efforts to comply and remain competitive in this shifting regulatory landscape. In the final blog of this 2-part series, we consider the advantages of partnering and the factors that are crucial for success.
For product manufacturers in the medical and diagnostics equipment industry, developing an effective product lifecycle management process is no longer a “nice to have” but a “must have”. From managing the cost of product ownership to transitioning product updates without disruptions in regulatory compliance, a long-term holistic view of product lifecycle management can help you maintain customer loyalty and build trust in new product development.
Is your business IVDR-ready, or are there treacherous gaps in your strategy? This November marks the halfway point in the five-year transition to the In Vitro Diagnostic Regulation (IVDR) 2017/746—a major regulatory overhaul that calls for reclassification and recertification of all IVD devices registered in the European Union. With its expanded scope and more stringent requirements, IVDR impacts the entire supply chain. The May 2022 transition deadline may seem a long way off, but there’s no time to lose. In this 2-part series, we help you take stock of the situation, with a special focus on how to prepare when it comes to managing OEM relationships and new partnerships.
Innovating, developing and bringing a new automated liquid handling product to market quickly, before requirements and needs change, is no easy feat. A software development kit (SDK) supporting your platform and components enables your developers to spend less time worrying about how to control robotic components and more time creating optimal interactions between the end-user and their application. Let’s look in more detail at what a robotics SDK is, what features it should have, and what benefits the right SDK can bring to your development timeline.
Analytical instrumentation is evolving so fast that engineers run the risk of their robotic platforms becoming obsolete before the development cycle can be completed. The competitive life science instrumentation market is expanding at an impressive 8.2% CAGR and is projected to be worth $85 Billion by 2022.¹ To keep ahead of the rapid rate of change, having a strategic OEM partner that is committed to continuous innovation and improvement is crucial. How can you be sure that your automation components provider or OEM partner has what it takes to help you deliver your automated liquid handling solution with the reliability and performance your customers expect? Here are some important questions to consider.
More than 90% of patients with signs and symptoms of myasthenia gravis can be readily detected and treated with a range of effective therapies. The key to early diagnosis and treatment that can lead to remission is the selection of sensitive, specific, and proven assays to detect and quantify the autoantibodies that cause myasthenia gravis. Fortunately, there are high-quality assays on the market that can save you valuable time in diagnostic procedures*, eliminate the need to develop in-house solutions, and ensure accurate and early disease detection.
What happens when lab automation projects are unsuccessful? One out-take is learning what creates a stronger process and methodology. That's exactly what we found at Tecan after working with several hundred customers on lab automation for multiple projects. This presentation reveals the top 5 pitfalls of custom automation based on real experience.
“Myasthenia gravis is eminently treatable,” say researchers at UCL’s Institute of Neurology1. Yet clinicians still find it challenging to detect and manage. In a new webinar entitled “Autoantibodies in Myasthenia Gravis,” Dr. Jan Damoiseaux, a Laboratory Specialist in Medical Immunology at Maastricht UMC+ in the Netherlands, explores the underlying mechanisms of the disease and explains how a two-assay strategy can improve the accuracy of determination of autoantibodies and help monitor therapeutic efficacy to improve patient outcomes.
Today’s hematology labs are faced with escalating demands to deliver robust and accurate blood test results quickly. At the heart of automated diagnostic systems for blood analysis are liquid handling pumps, which must deliver precise and accurate results every time. As well as being reliable, they must also be affordable and easy to maintain. Unfortunately, not all pumps deliver to these exacting standards. What are the most important factors for an engineer to consider when selecting a pump to meet the stringent performance required for a hematology automation system?
Myasthenia gravis is an autoimmune disease with an estimated prevalence of 14-20/100,000 population in the U.S.1 and 1-9 /100,000 population in Europe.2 Many affected individuals go undiagnosed. Myasthenia gravis can cause severe muscle weakness and greatly impact quality of life. Diagnosis can be difficult, but state-of-the-art disease biomarkers and targeted assays are available to increase the likelihood that a patient with myasthenia gravis is diagnosed early and can be treated appropriately. How can these biomarkers and use of the correct assays also help clinicians monitor therapeutic efficacy and support better treatment outcomes for their patients?
Anatomical pathology labs face ever-increasing pressure to meet demands for enhanced throughput, improved quality and cost savings. Additionally as we saw in the previous article in this series, anatomical pathology has to adapt to disruptive new methods that replace or enhance traditional ones and automation that will play a key role in reducing waste, error, and hands-on time. Employing automation solutions built for traditional methods can result in compromises in compatibility, throughput, and quality, which mean that novel solutions may be required. In this case, it may be time to consider partnering to develop the automated pathology system that delivers the performance a modern anatomical pathology lab needs.
How to overcome challenges like inefficient workflow and a lack of suitably trained staff is the question increasingly facing laboratories in markets ranging from diagnostics to food and beverages. Could sample-to-answer systems be the answer?
Improving lab procurement processes involves more than just putting e-procurement or lab management software in place. In most cases accessing, managing and analyzing the data that you use to support purchase decisions and feed into e-procurement tools is still a big challenge. In previous articles, we explored the value of automated collection of usage data from lab instruments and robotics. What capabilities and features should you look for when deciding which tools will best support your needs? Here are our top picks.
As labs face tighter profit margins and the need to minimize cost of goods, there is increasing pressure to implement more efficient and responsive mechanisms for procurement and inventory management. A large proportion of annual spend goes towards consumables like disposable pipette tips, microplates and kits. Procurement strategies based on lean and ‘just-in-time’ principles can improve cost-efficiency by reducing overhead and warehousing expenses. However, this often comes with a significant risk: without enough data about both availability of consumables and what you have in stock, you could run into costly unexpected out-of-stock scenarios. Here are three essential questions to ask when looking to reduce the risks of creating leaner, ‘just-in-time’ procurement processes.
As a procurement planner in the competitive life sciences sector, how do you ensure your organization adapts swiftly to the rapidly changing demands of customers and stakeholders? Whether supporting a CRO, pharmaceutical company, clinical lab, biotech business or academic department, procurement teams are under constant pressure to manage risk, reduce costs and keep their organizations profitable. Advancements in technology and business practices are widening the influence of procurement on business operations, requiring procurement teams to collaborate even more closely with other functions, including lab management. Here are three major trends that are transforming procurement management:
The anatomical pathology – or histopathology – workflow has not changed in decades, yet volumes increase and laboratories expand. A serious shortage of qualified personnel is making matters even worse. Added to that, errors arising largely from manual procedures cause extra work, and unfortunately it is the patients who suffer the consequences. Modernization may be essential for survival of histopathology labs but making the business case for automation can still be a challenge, especially given that it may involve bold and potentially costly changes to well-established protocols and lab infrastructure. Here are 5 compelling arguments for automating your histopathology lab now.
Congratulations. It took you quite some time and effort to convince your management or institution on the value of investing in automating your experimental or clinical workflow. The applications were submitted, the presentations were made and the wheeling and dealing to secure the budget resulted in you and your team landing the investment. You've arrived. Now all you have to do is choose the robot and get it up and running.
HMGB1 is a key mediator in the immune response and increased levels can be important indicators of disease. In this, the last in our series on HMGB1, we will look at the performance of the IBL HMGB1 ELISA Kit, which has been used to demonstrate the value of total HMGB1 as a clinical biomarker in a wide range of sample types and diseases. This kit is regarded by key opinion leaders as the gold standard in the field and has been used in more than 800 publications.
In the first article in this series, we looked at how HMGB1 has taken an increasingly important position as a key mediator in the immune response and as such plays a major role in a large number of diseases – from sepsis to cancer. As Professor Helena Erlandsson Harris, a pioneer in HMGB1 research, says, “I am convinced that the next step will be even better data to demonstrate the usefulness of HMGB1 as a prognostic/diagnostic biomarker. This has been hampered by the need to understand the isoforms that control different functions and also the methods for measuring HMGB1. It would be even better if HMGB1 detection were included in larger biomarker panels.” HMGB1 has indeed been included as a necessary biomarker in consensus guidelines for the detection of immunogenic cell death. The question is how to measure it. In this article, we will look at the development of increasingly sensitive, reliable and easy-to-use assays for clinical research and routine use and how this has been complicated by the need to resolve the isoforms, and also overcome interference caused by auto-antibodies and other proteins that naturally interact with HMGB1 to modulate its function.
As a nuclear protein present in most cell types, HMGB1 (high mobility group box 1) is a key mediator of the immune system in health and disease. Interest in HMGB1 has increased dramatically as the protein has been shown to be critical to the cell’s response to stress and plays a major role in many disease states, including infectious diseases, ischemia, immune disorders, neurodegenerative diseases, metabolic disorders, and, not least, cancer. Highly conserved in mammals, HMGB1 (also known as HMG-1 and amphoterin) is primarily located in the chromatin where it stabilizes chromosome structure and plays a key role in controlling gene expression.
The anatomical pathology – or histopathology – services sector is projected to grow, but histopathology labs the world over are struggling in the face of shortages in trained pathologists, increasing regulatory pressure, changing reimbursement policies, and shifting paradigms in healthcare. Modernization of this highly conservative field is imperative. What are the key drivers of change in the industry, and how can anatomical pathology labs prepare to embrace the future? Will automation and digitalization offer a solution?
We may well be on the threshold of a new hope for oncology. Shorthanded to ctDNA, circulating cell free tumor DNA is sloughed off from tumors. It can be detected in liquid biopsies of just a few milliliters of blood. This could revolutionize what oncology can achieve by diagnosing cancers earlier and more efficiently.
Are you guilty of making decisions without the data to back them up? In today’s busy labs, mission-critical decisions about laboratory equipment purchases, service contract renewals, consumables spending, and staffing are often made on the basis of incomplete information. Having a clear picture of instrument usage and burn rates of associated reagents and consumables can help you uncover new ways to cut costs and improve performance in the laboratory. In the previous article we highlighted how crucial it can be for labs to monitor instrument utilization data. Now let’s consider more specifically what you can learn from analyzing all this data.
As we move into the 2019 budget cycle with signs of a global economic slowdown on the horizon, laboratory administrators are no doubt feeling the heat. A combination of poor forecasting, inefficient use of resources, and a sudden economic downturn could create the perfect storm to capsize operations. Despite these high stakes, critical decisions about budget allocation, expensive equipment purchases, workflow optimization and cost-cutting strategies are often made based on incomplete information or even pure guesswork about laboratory asset utilization.
As sequencing grows significantly in China, how are Chinese home-grown companies making the most of it?
In December 2017, the UK and China announced a joint initiative to advance collaboration in science and innovation¹. The first bilateral science and innovation strategy of its kind to be developed by China jointly with another country, the UK-China Joint Strategy for Science, Technology and Innovation Cooperation builds on existing collaborations dating back to 2014, and represents yet another step change in China’s efforts to grow their leadership in healthcare markets. On the back of initiatives such as this, China’s home-grown companies are forging new partnerships internationally, and are well positioned to flourish as a result.
Budget constraints and short-term funding are a fact of life for most research labs. The problem can be particularly acute if you are working with living cells, which presents complex technical challenges. Working with precious or irreplaceable cell samples, for example when researching rare diseases, adds additional demands. To make matters worse, the types of assays, methods and instrumentation you need to answer complex biological questions in live cell models may change significantly during the course of your research.
Butterfly disease has been called “the worst disease you’ve never heard of”. It’s an excruciatingly painful genetic condition that makes life miserable for the affected, and currently, there’s no cure. To make matters even worse, with as many as 27 different varieties of Epidermolysis bullosa (EB) and multiple genes/mutations, each patient is different, so there is no overarching, one-size-fits-all treatment solution. Despite its devastating effects on patients, mainly children and their families, funding is limited, as the disease is so rare: it affects only 1 in 20,000–50,000 of the population.
Funding for the study of rare diseases and medical conditions (sometimes called orphan diseases) is often limited and short-term, which can put off both basic research and pharma investment. Yet there are numerous reasons why rare diseases deserve much more attention than they currently receive, instead of being left like orphans out of the research picture. Is it time for academia, pharma, biotech and society in general to re-think our views about investing in the study and treatment of rare diseases and medical conditions? We think so, and we’ll present five reasons why.
Much of the work done in a genomics lab is repetitive, labor-intensive, and just plain boring. Is this really the best use of highly skilled scientists? How do you keep staff motivation up when another couple hundred samples roll into the lab? Most importantly, all this manual labor creates huge problems in terms of human error and amplified costs. Here are some major sources of tedium and error in the genomics lab where improvements can make a big impact—reducing costly errors, increasing productivity, and possibly even saving your sanity.
The trend towards more automated workflows in research is helping to significantly improve data quality as well as laboratory productivity. But when it comes to choosing an automated system for liquid handling and dispensing, it can be difficult to decide between the large range of technologies and platforms currently available. Here are a few pointers to help you select the features that are most important for your lab.
Cardiovascular diseases claim more lives than all forms of cancer combined, accounting for 17.3 million deaths per year. Heart attacks are a primary symptom. The longer it takes to diagnose and treat a heart attack, the greater the damage. But progress in identifying relevant cardiac enzymes and other biomarkers has increased the likelihood of rapid and accurate diagnosis to ensure effective treatment and improve long-term survival. Several cardiac markers have been developed for the rapid diagnosis of patients with chest pain and suspected acute coronary syndrome. One of these markers, cardiac troponin, stands out and the ability to better define troponin levels is expected to help diagnose heart attacks more effectively, and even predict them.
They say that the era of the $100 genome is upon us, but is that true for you? While cost analyses of DNA sequencing indicate that this landmark is finally within reach, the reality is that most NGS labs are still spending far more than that. Here we explore some hidden costs of NGS that occur upstream of sequencing. How many of them are culprits in your lab?
The evolution of metabolomics from research to applied science has not been as rapid or dynamic as genomics or proteomics. However, the promise of metabolomics as a diagnostic strategy is becoming much clearer.
A main presentation track at SLAS2018 entitled "Cellular Technologies" will include the session "Development of Cellular Models for Phenotypic Screening," chaired by Kristen Brennand, Ph.D., New York Stem Cell Foundation-Robertson Investigator and Associate Professor, Departments of Genetics and Genomics, Neuroscience and Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY. We spoke to Dr. Brennand about the key topics, highlighted trends, and target audience for the talks and presenters he has prepared.
In the rapidly evolving, data-driven life sciences sector, it is increasingly common to see labs developing their own in-house solutions to enable scale-up of novel methods, and to bridge technology gaps not yet filled by automation providers. The track "Automation and High-Throughput Technologies" at SLAS 2018 includes the session "In-House Automation: Devices and Software Developed Internally," which will explore this growing trend. We interviewed the session chair, Louis Scampavia, Ph.D., of The Scripps Research Institute to learn more.
From phenotypic assays to 4D cell tracking, high-tech methods are of increasing importance for complex screens. This expanding area will be a main presentation track at SLAS 2018 entitled "Assay Development and Screening" and co-chaired by Dr. Ralph Garippa, Memorial Sloan-Kettering Cancer Center and Dr. Edward Ainscow, Carrick Therapeutics. Dr. Garippa provides more insight on this timely and broad-ranging track, which will highlight case histories in assay development, implementation for high throughput screening (HTS) campaigns, and triaging for hit confirmation.
High throughput screening methods for phenotypic drug discovery are in demand, as novel disease models arise and increase in complexity. A main presentation track at SLAS2018 entitled "Automation and High-throughput Technologies" will include the session "Automating Target-Based and Complex Phenotypic Drug Discovery," chaired by Shane Horman, Ph.D. of the Genomics Institute of the Novartis Research Foundation. We spoke with Dr. Horman to learn more about the key topics, highlighted trends, and target audience for the session.
Like gravity, some phenomena are so integral to our existence that we’re barely conscious of them. Maybe that’s why the research community was largely taken by surprise when it was announced that this year’s Nobel Prize in Physiology or Medicine was awarded to three American scientists for their seminal work on circadian clocks ¹. But consider the synergies with next gen sequencing (NGS) and gene editing technologies, and it becomes clear that the implications of their work are far-reaching.
The presence of excess cortisol hormone in saliva can be an indication of a number of serious biochemical imbalances that include chronic stress, adrenal fatigue, obesity, diabetes and conditions like Cushing Syndrome. Increasingly, spit-and-measure testing is becoming the go-to test for cortisol.
The popularity of mass spectrometry based testing is growing all the time. As a result, businesses in the diagnostics industry offering mass-spectrometry-based clinical assays, especially analytical laboratories in toxicology environments, are facing a number of major challenges. These include meeting scaling requirements that are non-linear, overcoming regulatory uncertainties while guaranteeing business continuity, raising ROI on LC/MS instruments and lowering turnaround times.
Cognitive computing and artificial intelligence have the power to save us from drowning in the vast and growing sea of data needed for precision medicine, but what will it take to achieve a timely return on investment? Experts from multiple disciplines will gather to share their perspectives on this challenging problem at the upcoming Tecan Symposium in Salt Lake City on November 14th.
The drive to make healthcare more targeted and more personalized has accelerated the application of increasingly sophisticated technologies, such as next generation sequencing (NGS). The result has been the introduction of some NGS-based tests to be used to direct targeted therapies to the right patient. The power is great, but the challenges are many, including how to standardize for routine use.
In an increasingly regulated industry, clinical laboratories and manufacturers of in vitro diagnostic (IVD) tests are feeling the pressure to ensure regulatory compliance, while at the same time striving to increase productivity and bring innovative technologies on stream. At times, this balancing act can seem like a losing proposition.
Hospitals are becoming the new centers of innovation for novel clinical diagnostic tests. While this is enabling more sophisticated and personalized approaches to disease prevention, early diagnosis, and targeted treatment, it also has the potential to create major headaches for regulatory management of clinical labs.
As we have seen in the previous posts in this series, developing validated analytical methods becomes more cost- and time-effective when solutions with guaranteed compatibility are incorporated into the analytical system.
A long-term clinical lab study lasting over 10 years showed that more than 60% of all mistakes in the stat lab (the lab that receives high priority samples) can be attributed to the pre-analytical phase. This figure has not changed much from 1997 to 2007,1, 2 despite advances in the technology.
Well-documented reliable, accurate data that meets regulatory demands is crucial for success The key is to develop robust analytical methods based on instruments and other components that perform well together to ease the way forward through Installation Qualification and Operational Qualification (IQ/OQ) and method validation.
As the numbers of addicts and drug-related deaths continue to soar in the US and in Europe, forensic and diagnostic labs are looking for efficient methods to discriminate drugs of abuse that provide an easy workflow and are sufficiently sensitive to detect extremely low quantities of highly potent synthetic opioids in the urine of victims.
Scinomix, Inc., founded in 2001, creates customized solutions for labeling tubes, vials and plates in many life science applications. We took the chance to ask Nigel Malterer (CEO) and Jonathan King (Automation Software Engineer) at Scinomix about how automated barcode labeling solutions are helping to improve productivity, reduce errors and costs, and increase control over lab workflows.
Barcodes play a central role in minimizing the risk of error in lab automation by providing secure tracking of components throughout the workflow. Barcode-guided lab automation can be simple and cost-effective, with significant paybacks thanks to productivity increases.
With multiple tests to perform on a tiny volume, samples are getting more precious. And as Next Generation Sequencing pushes the envelope on cost and throughput, scientists are looking for ways of reducing reagent volumes without compromising on quality. Tecan has a tip.
When developing a liquid handling instrument, it is important to be first to market for early market leadership. Dr. Claudio Bui, Head of Product Concepts, Tecan, considers key elements to completing a project quickly and efficiently, including common pitfalls.
How do cancer cells die? Necrosis of a tumor, or unscheduled cell death, has been linked to tumors outgrowing their blood supply. But now it is believed that the release of HMGB1 promotes the survival of the remaining tumor cells.
Steve Pemberton, Vice President, Sales and Marketing, reflects on applications across multiple market opportunities including IVD, food & beverage and highly complex CLIA laboratories and the resulting value proposition of Rheonix.
A symptomatic menopausal woman may require periodic testing of her estrogen and progesterone levels to make necessary adjustments in the dosing of hormone replacement therapy. An athlete undergoes steroid hormone testing leading up to a major competition to assess his level of exercise-induced exertion and optimize his training routine.
Diagnostic testing has a long, bloody (i.e., blood-based) history, and when a physician orders a test, the usual response is to strap on a tourniquet, pull out a syringe, and extract a venous blood sample. For some tests, though, and, especially to measure levels of steroid hormones such as estrogen, testosterone, or cortisol, a blood sample might not be the best choice.
Robotics and automation have become essential to the future plans of drug discovery and clinical diagnostic companies. Executives are looking to increase productivity and reduce costs, and automation fits the bill in every respect.
As Product Manager for Liquid Handling and Robotics at Tecan, I had the opportunity to introduce the power of the Tecan D300e Digital Dispenser at SLAS2016. You can view the presentation here. Without giving too much away, all you need to do is add your liquid and the dispenser does the rest.
(Part 2 of 2. Read Part I). In 1948, Bill Koster of the Variety Club of New England and Dr. Sidney Farber working at the Children’s Hospital Boston had launched The Children's Cancer Research Fund, aimed at supporting a hospital dedicated to the research of childhood leukemia. But they needed a poster child to boost fundraising.
In his book, The Emperor of All Maladies, Siddhartha Mukherjee tells the story of one of the turning points in the history of cancer medicine. A turning point that he dates to May 1947. In this two-part article we will look at how cancer research has been transformed by fundraising.