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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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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

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The leader in next generation immunodiagnostics

By Nicholas Smith

Jeff Bishop, Vice President, Research & Development, Singulex, explains the proprietary single molecule counting (SMC™) technology which has become today’s gold standard for immunoassay technology.

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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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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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The next giant in genome sequencing? China

What’s driving China’s massive growth in next generation sequencing (NGS) and how are its home-grown companies making the most of it? 

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