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The Blog

Selected category: Clinical Diagnostics

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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...

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The case for saliva testing in the diagnostics and management of female hormone imbalance

By Aron Gonshor (in collaboration with Nastya Yeska and Dajana Domik) 

Female hormone levels have been measured using blood tests for decades.1 However, blood sampling is costly, invasive, and often logistically difficult. Consequently, there has...

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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...

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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...

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High Quality ELISA for measuring HMGB1 in COVID-19 samples

By Oliver Schmidt

HMGB1 is a key mediator in the immune response to SARS-CoV-2, and increased levels can be an important indicator for COVID-19 understanding and its prognosis. In this final piece in our series, we look at the performance of Tecan’s...

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How to measure alarmin HMGB1 in SARS-CoV-2 immune response

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, playing a major role in many diseases, from cancer to coronavirus. There is now...

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Exploring the role of HMGB1 in the immune response to COVID-19

By Oliver Schmidt

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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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....

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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...

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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...

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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...

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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...

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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...

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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,...

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Four 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...

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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...

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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...

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

By Magali Wolff

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,...

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