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…
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…
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…
Genetic Screening and Big Data’s Influence on Drug Production and Biomarker Identification
The Human Genome Project (HGP) was largely successful in its goal to identify the genetic blueprint of life. The scientific community has begun to translate…
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…
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…
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…
A Dose of Pharma and Biotech News: December 12, 2019
With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest…
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…
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…