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Selected category: Clinical Diagnostics

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Diagnostic saliva hormone testing provides alternative to needles

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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Reducing risks in IVD instrument development

By Nicholas Smith 


The In Vitro Diagnostics (IVD) medical device market is fast-paced and highly competitive, with new and advanced applications appearing every day. High technical risks, cost overruns, schedule delays and missed end-user targets are just some of the pitfalls that can derail a project or lead to an unsuccessful product. Moreover, the expertise requirements and regulatory landscape for IVD medical devices continue to grow in complexity, making it even more difficult for a diagnostics company to keep pace and bring its platform solutions to market in a timely manner and with the appropriate mechanisms in place to fully support the customer. Here we take a closer look at why a systematic risk-based development approach is essential for IVD device development, and how the right OEM partner can be crucial for success.

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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 in vitro diagnostic device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. You may need to react quickly to unexpected circumstances requiring rapid changes in the throughput of your instruments. What else should you take into account when selecting an ideal OEM partner?

Every partnership has two sides and each must work together to reach success. In this case, there is the OEM partner and an OEM customer. Would any OEM partner fit with any OEM customer? There are several success factors that OEM customers and OEM partners need to consider to develop a successful partnership.

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Seven elements for successful IVD instrument development with your OEM partner

By Nicholas Smith 

You have made the decision to enter into the development of an IVD medical device 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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Things to consider before introducing lab automation to in vitro diagnostics

By Nicholas Smith 

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.

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For data reproducibility: automation of ELISA test kit protocols wins

By Magali Fischer

Automating robust assays is a way forward

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.

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The ups and downs of DIY lab automation

By Nicholas Smith

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.

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Mind the gap: How to navigate the IVDD-IVDR transition – Part 2

By Laura Nea

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.

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Mind the gap: How to navigate the IVDD-IVDR transition – Part 1

By Laura Nea

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.

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Automating your anatomical pathology lab: how to get there faster

By Yves Wurmitzer

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.

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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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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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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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Get a competitive edge in clinical markets with modular OEM solutions

By Markus Vogler

The last decade has seen dramatic changes in the world of diagnostics, with experts even referring to the present time as the start of the fourth industrial revolution. Digitalization, along with other technological advances such as the increased use of automation and robotics, machine learning, artificial intelligence and cloud computing, is impacting every industry from manufacturing to pharmaceutical biotechnology. These technologies, as well as breakthrough research in various fields such as gene editing, stem cell technology and regenerative medicine, are having a huge impact on the clinical diagnostics industry.

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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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Embracing change in clinical labs and in vitro diagnostics: 6 lessons from the automotive industry

By Markus Vogler

Similar to the highly competitive automobile industry, clinical laboratories and manufacturers servicing the clinical diagnostics and life science markets, are always under pressure to increase quality and reliability. Likewise, they must at the same time cut costs and bring new products to market in a climate of rapid global change and increasing regulatory pressures. Specialist car manufacturers are leading the way with innovative new approaches to cope with the challenges. Those who are successful have learned how to be more adaptable and how to get their innovative products to market faster.

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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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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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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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