Blog

Fraudulent and unreliable laboratory testing data in premarket submissions

March 25, 2024

Embark on an important journey by understanding how crucial it is to choose a reputable third-party lab for your medical device. The success of your device relies on partnering with a lab that knows FDA rules and understands your device’s field.

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Sample Sourcing Team

September 28, 2023

Future Diagnostics specializes in the development and validation of various IVD assays, both manually and on an automated platform. During development and validation, specific assay characteristics need testing, for which disease state samples are required. Sourcing the appropriate samples is challenging and time-consuming. Multiple sample suppliers need to be contacted to ensure timely availability and delivery

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The art of Bioconjugation

March 30, 2023

With state-of-the-art knowledge in the field of IVD assay development, Future Diagnostics also has extensive expertise in bioconjugation techniques. We offer this important component within assay development either as part of a comprehensive IVD manufacturing process, or as a separate service. In the process, we optimally link the desired molecules. And in addition, we also think about their final application. In this blog you will learn more about what bioconjugation is, and how a good conjugate is established.

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This is the future of diagnostics

May 18, 2022

It’s a hotly debated issue in the medical community: “the future of diagnostics”. An uncertain subject with a changeable nature. But just because the road ahead is not yet fully mapped out doesn’t mean we can’t philosophize about it. And so our own Head of Research and Science Ernst Lindhout recently held a survey among colleagues and other peers to see where our field might be heading. And to be able to anticipate that which may await us…

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These are IVD products

December 06, 2021

IVD products; working with them is daily business for us. The term is regularly used in meetings, in the corridors of our building and on our website. But people from outside the company sometimes ask us: what exactly do you mean by ‘IVD’? Time for a clarification. In this blog, we will explain what IVD products are, what you can do with them and why their development is so important for global healthcare.

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The importance of companion diagnostics in personalised medicine

November 24, 2021

Paracetamol is a godsend for many. However, for many types of pain, this medicine does not work. But not to worry. You can cheaply get a pack of ibuprofen that will probably do the trick. But what if the drug you initially wanted costs thousands of euros per treatment? Then it is important to know in advance: Is this really the best medicine? Companion diagnostics predict the applicability of a drug to a specific person. This saves time, money and often a lot of unnecessary discomfort or suffering.

 

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Immune test or PCR test

June 09, 2021

Where our field used to be a rather unknown and unpopular world for our friends, family or strangers, the subject of testing has gained a lot of popular interest lately. But even though the advent of COVID-19 has made our daily work suddenly more exciting for everyone, it remains a difficult topic. After all, whether it concerns a test in a test lane or a home test, it’s difficult to understand how they work. In this blog we explain it all.

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Sensitivity and specificity

March 08, 2021

Suppose you buy a home test. No home test is the same, so how reliable is the one you just bought? What is the probability of a false positive or false negative result? This is important to know, especially with diagnostic tests. To answer that question, several aspects need to be taken into account, in particular, sensitivity and specificity. Let us explain how exactly this works.

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The different areas of immunoassays

October 08, 2020

Be it for determining a Vitamin-D deficiency or the presence of COVID-19 or hiv in clinical specimens; there are immunoassays for measuring each of these specific biomarkers. This blog provides an overview of the different immunoassays present in the current market.

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The process from A to Z

September 07, 2020

IVD product development is a delicate and complex procedure. Only by using the purest of products, highly skilled professionals and effective communication do we reach the optimal product development process. Since we take pride in our in-house processes, we are more than pleased to present to you a closer look behind the doors of our facility on the comprehensive overview of product development at Future Diagnostics: the process from A to Z.

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