Molecular Dx Control

From Extraction to Result: Applying VLP Controls for Comprehensive Performance Validation Across Each Stage of an MDx Assay

As regulations tighten, find out how to improve process control through every step of a molecular assay, from samples to results!
DNA genotyping is a powerful technology that allows the identification of genetic variations that can lead to an increased risk of developing certain diseases. Additionally, genotyping has a fundamental role in companion diagnostics, as it enables the characterization of patients’ genetic profiles that can be used to guide treatment decisions.
Here, we will introduce two novel master mixes developed to provide PCR-based identification of mutations directly from the clinical samples, such as blood, plasma or FFPE tissue, bypassing DNA extraction and streamlining the analysis of both liquid and tissue biopsies.


Steve Hawkins, Ph.D., Product Marketing Manager

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Novel Solutions for Improved Process Control in Your Molecular IVD Assays

As the IVD industry continues to evolve, new regulations frequently come into place to better control an innovative and growing industry. Molecular IVDs in particular are experiencing tighter regulations regarding the presence of appropriate controls within the assay. All tests must include both positive and negative controls which are subjected to the whole testing process, including the extraction step. Novel co-extracted exogenous controls are providing cutting edge solutions for monitoring RNA or DNA analysis including the detection of potential inhibition. These controls can be used across a variety of sample types and assays, representing a significant advantage over traditional spike-in controls.

Michele Amasio, Ph.D. (Research and Development Senior Manager, Meridian Bioscience)

Steve Hawkins, PhD (Product Marketing Manager, Meridian Bioscience)

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