IP-10MAP 3 Plex
Myriad RBM’s IP-10 MAP 3-plex is a valuable tool for studying chronic inflammatory diseases.
Interferon induced protein 10 (IP-10 or CXCL10) is a chemotactic chemokine that attracts T-lymphocytes, natural killer cells, and monocytes. The protein exists in multiple forms and in some cases it may antagonize immune system activation depending on its cleavage state. Studies have found IP-10 induction to be involved in many disorders including autoimmune diseases, kidney injury, cancer and infectious diseases such as hepatitis C where measurement of the short and long forms have been used to predict response to therapy. IP-10 MAP was developed and validated by Myriad RBM in our CLIA-certified lab using antibodies from ABD Serotec Morphosys to measure the long, short, and total forms of IP-10 precisely and accurately. View Paper
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Rat KidneyMAP®
A 12-Biomarker Multi-Analyte Profile (MAP) for Detecting Kidney Toxicity in Rat Preclinical Drug Studies.
Introduction – Rat KidneyMAP® and Biomarker Qualification by the Predictive Safety Testing Consortium
Drug induced toxicity is responsible for killing 30% of promising compounds from early preclinical studies and can negatively impact both clinical development programs and approved drugs. Upwards of 20% of all clinical cases of acute kidney injury (AKI) occur as a result of drug exposure. To address the need for improved detection of drug-induced nephrotoxicity, Rules-Based Medicine (RBM), in close collaboration with the Predictive Safety Testing Consortium (PSTC), created a specific biomarker panel called Rat KidneyMAP®. The Rat KidneyMAP was instrumental in the success of the PSTC’s first set of studies, published in the May 2010 focus issue of Nature Biotechnology, that detail the regulatory (FDA and EMEA) qualification of kidney biomarkers for preclinical use in detecting drug-induced kidney injury [1-12]. Herein we review the key findings and implications of this milestone and why biomarker panels like the Rat KidneyMAP are becoming standard practice for preclinical toxicity studies. View Paper
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RBM Quality Control Systems
An Overview of Assay Quality Systems at Rules-Based Medicine®, Quality Control White Paper By Brian T. Welsh, Ph.D. and James Mapes, Ph.D.
Abstract
Stringent guidelines of quality assurance and control serve as the foundation for dependable and reproducible results in any analytical endeavor. To ensure the highest caliber data, Rules-Based Medicine (RBM) has established a rigorous set of criteria that serve as a guide through every stage of sample processing, from the development, validation, and manufacturing of our assays; to the testing,quality controlling and reporting of the data. Here we highlight step-by-step, the measures implemented by RBM that take Luminex xMAP® technology to a new level of reproducibility and ruggedness. The RBM platform combines the sensitivity and dynamic range of microsphere-based immuno-multiplexing with the precision and dependability of automated liquid handling. Together these features set RBM apart from other biomarker testing labs by offering high quality, cost-effective immunoassay measurements. View Paper
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TruCulture®
A simple whole blood collection and culture system for quantifying physiological interactions of the human immune system in the clinic, By Dr. Manfred Schmolz and Dr. Dominic Eisinger
Abstract
Accurate measurement of immune activity in relation to therapeutic dosing is an important part of many clinical trials, yet is poorly addressed by traditional techniques. Typical immune activity monitoring is performed using isolated leukocytes or even sorted subpopulation culturing methods followed by an analytical measurement.
These methods require the shipment of intact blood samples to a cell culture lab plus extensive manipulation that leads to alteration of the in vivo physiological environment as well as cell stress and subsequent poor utility and reproducibility.
TruCulture is a simple, reproducible method that eliminates such extensive manipulation and provides ease of use for sample collection and downstream analysis. Every feature of the TruCulture system is designed to give researchers the ability to reproducibly and accurately capture ex vivo immune cell activity to better characterize the efficacy and safety of a new drug, explore disease states, or develop new diagnostic tests. View Paper
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