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Selected category: Diagnostics & Biomarkers

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Adapt or perish? Anatomical pathology labs at a tipping point

By Yves Wurmitzer



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?



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Oncology prognostics: Why analyzing circulating cell free tumor DNA matters

By Nicholas Smith

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.

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Five ways instrument utilization data can boost your lab’s efficiency

By Michelle Aichele



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.


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Is what you don’t know costing you? Why instrument utilization data could be your lab’s biggest asset

By Michelle Aichele

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.

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The next giant in genome sequencing? China

By Nicholas Smith


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.

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Three ways an automated microplate reader cuts costs of live cell research

By Dr. Katrin Flatscher

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.

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4 disruptive trends that are shaping the future of clinical diagnostics

By Markus Vogler

The world of diagnostics, like so many other industries, is entering what leaders in the World Economic Forum are calling the fourth industrial revolution. Digitalization, robotization and automation have given rise to highly flexible “smart factories” as well as laboratories that can handle both routine/high volume analyses and highly customized analyses at competitive prices. This is coupled with an ongoing integration of the entire value chain – from subcontractor to customer.

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Butterfly disease: important lessons from a rare disease research

By Katrin Flatscher

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.

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Five critical reasons rare diseases deserve research attention now

By Katrin Flatscher

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.

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OMG I'm bored! Sources of tedium and error in the genomics lab

By Enrique Neumann

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.


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Automating your research? Consider these must-have features when choosing a liquid handling system

By Kevin Moore

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.

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The heart of the matter: finding the 99th percentile for high-sensitivity troponin assays

By Alexandra Sommer

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.

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Is NGS costing you more than you think? Some considerations

By Dr. Enrique Neumann

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?

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Five secrets to a successful IVD OEM partnership

By Nicholas Smith

You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned IVD device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. What else should you take into account when selecting an ideal OEM partner?

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Rise in clinical metabolomics will benefit from automated sample preparation

By Christian Scherling

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.
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Phenotypic screening as a pathway to personalized medicine for neurologic diseases

By Simon Fogarty

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.

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Can DIY automation solutions bridge gaps in drug discovery? SLAS2018 takes a look

By Simon Fogarty

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.

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Advances in assay development are focus of SLAS2018 track

By Kevin Moore

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.

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SLAS2018 will explore advances in high throughput phenotypic screening

By Simon Fogarty

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.

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Diagnosing Alzheimer’s earlier: the biomarker breakthrough

By Alexandra Sommer

The race to find a way of spotting and treating Alzheimers at an early stage is heating up but there’s a long way still to go. Or is there?

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It’s about time. Nobel Prize honors pioneers in circadian clock biology

By Kevin Moore

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. 

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Spit-and-measure testing – identifying over-production of cortisol

By James O'Brien

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. 

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ROI from the LC/MS lab: challenges in a regulated environment

By Rohit Schroff

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.

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Drowning in data: Can precision medicine get smart enough, fast enough?

By Nicholas Smith

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.

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Personalized next generation sequencing in companion diagnostics: the promise and the challenges

By Alexandra Sommer

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.

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Struggling to balance GxP compliance and productivity? Not all automation platforms are created equal

By Jason Meredith

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.

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Why automation of laboratory developed tests is key to easing regulatory compliance

By Jason Meredith

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.

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Achieve validation faster – integrate Tecan IQ/OQ validated tips into your automated liquid handling solution

By Severin Heynen

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. 

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Make your lab work flow with Fluent ID™

By Florence Collins

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.

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Using integrated solutions to efficiently meet regulatory demands

By Severin Heynen

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.

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The multiple challenges of efficiency and sensitivity in screening today’s drugs of abuse

By Christian Scherling

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.

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How automated test tube barcoding adds reliability and stops unnecessary errors

By Florence Collins

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.

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How to make the right choice for barcoding sample tubes – standards, challenges and considerations

By Florence Collins

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. 

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How to reliably get more data from less volume

By Severin Heynen

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.

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Options to Reduce Time-to-Market with Your Next Liquid Handling Instrument Development Project

By Claudio Bui

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.

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Lament of the dead cancer cell

By Oliver Schmidt

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.

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Molecular diagnostics addresses diverse market needs

By Nicholas Smith

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. 

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Benefits of saliva hormone testing

By Magali Fischer

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.

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The choice is clear: saliva vs. blood diagnostics for hormone testing

By Magali Fischer

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. 

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Diagnostic saliva hormone testing

By Magali Fischer

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.

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The economics of robotics

By Martin Braendle

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.

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The gold standard ELISA for measuring HMGB1

By Oliver Schmidt

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.

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How to measure alarmin HMGB1

By Oliver Schmidt

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.

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IVD instrument development with an OEM partner: Six essential elements for success

By Nicholas Smith

You have made the decision to enter into the development of an IVD system solution for your customers. You have learned that inviting an OEM partner into your project could be beneficial to reduce risks and fill expertise or skill gaps, but you are still hesitant. What are the key elements that you should consider to ensure the success of the collaboration?

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11 key points to install and efficiently initiate a new automated assay system in your laboratory

By Hal Wehrenberg

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.

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Reducing risks in IVD instrument development

By Nicholas Smith

The In Vitro Diagnostic (IVD) medical device market is one where new and advanced applications are appearing every day. Equipment expertise and regulations are becoming increasingly complex to the point that a diagnostic company may not be able to keep pace and bring their platform solution to market in a timely manner with the appropriate support level required by the customer.

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Five essential software questions to ask before buying a liquid handling instrument

By Hal Wehrenberg

All automation is controlled by software and understanding the differences between options can be complicated. Underestimating the impact of software may set back your budget or critical timelines.

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What the alarmin HMGB1 teaches us about cellular stress response

By Oliver Schmidt

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.

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Miniaturization empowered - discovering the remarkable benefits of the Tecan D300e

By Dr. Manuel Bauer

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.

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The top 5 pitfalls of custom automation

By Avinash Peddi

What happens when lab automation projects are unsuccessful? One outake is learning that 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 from SLAS2016 reveals the top 5 pitfalls of custom automation based on real experience.

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"Self aware" automation - SLAS 2016 presentation

By Hal Wehrenberg

What happens when the robots in your lab become self aware? Take a closer look at this issue and the possibilities by watching this presentation on self-aware automation from SLAS 2016. 

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The short history of cancer research funding- Part II

By Martin Braendle
(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.

 
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The short history of cancer research funding - Part I

By Martin Braendle
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. 

 

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Molecular diagnostics – a closer look at sample to answer

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?

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