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Category: Biomarkers

Receptor Occupancy Flow Cytometry Assays

This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry for bioanalysis, part 2 investigated…

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Multiplexed Cytokine Analysis in Drug Development

Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling functional responses. The nature of…

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Is ISR Needed For Biomarker Assays?

Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in…

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FDA RACE for Children Act: What You Should Know

Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required…

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Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology

Tumor tissue biopsies have been the traditional method of identifying and analyzing cancer cells. But in addition to being invasive and risky, they have many…

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The Importance of Cytokine Detection and Analysis

Cytokines are a broad class of soluble proteins, glycoproteins, and peptides that act as chemical messengers of the immune system. These small proteins are essential…

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C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish…

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510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive…

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The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment

Flow cytometry is an ideal platform for many applications involving the study of complex cell populations. In the first blog of our new “The Fit…

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Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment

Many immuno-oncology therapies are seeing success and showing promise for the future, including CAR-T cells, tumor-infiltrating lymphocytes (TILs), checkpoint inhibitors, and natural killer cell therapies.…

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