Based on our reputation as a market leader for genomic services, Q2 Solutions | EA Genomics has been chosen to partner with many prestigious foundations, projects and consortiums on a number of groundbreaking projects. These studies are helping the scientific community apply genetic technology to clinical medicine.
Q2 Solutions | EA Genomics and HemoShear LLC, a biotechnology research company and leading developer of human and animal cell-based surrogate systems for discovery and assessment of new drug compounds, have partnered to develop the first comprehensive relational database for evaluating the vascular pharmacology of new drug compounds. Using HemoShear’s human relevant systems, the database will profile how human vascular cells respond at the genomic level to approximately 75 existing drug compounds that span a wide range of drug classes and have been accepted, black-boxed, or withdrawn from the market. Pharmaceutical companies can use this database to establish a true risk profile of their compounds and identify and investigate potential positive or negative effects.
Q2 Solutions| EA Genomics will generate the database’s extensive genomic content by sequencing more than 2,000 human RNA samples. The product will be the transcriptome of each sample, which correlates to the state of the vascular cells in response to a specific drug
Allegro Diagnostics and Q2 Solutions | EA Genomics will conduct a validation study of Allegro’s BronchoGen™ diagnostic test’s analytical performance, the results of which will mark the next milestone for expected commercialization in 2013 of BronchoGen as a CLIA-approved laboratory developed test.
The validation study, a prerequisite for meeting rigorous CLIA approval requirements, will verify BronchoGen’s accuracy, precision, sensitivity, specificity and other analytical performance metrics for detecting lung cancer in a cohort of 600 extensively phenotyped clinical specimens. Gene expression data for the study will be generated using robust high-throughput PCR assays in EA’s CLIA-certified laboratory.
Q2 Solutions| EA Genomics is a laboratory service provider for Second Genome. Second Genome uses third-generation PhyloChip™ technology enabling microbial community analysis to improve environmental and human health. PhyloChip technology was a recipient of the R&D 100 Award and the Wall Street Journal Technology Innovation Awards. Developed at Lawrence Berkeley National Labs, the assay simultaneously detects the presence and relative abundance of tens of thousands of different bacteria from any DNA sample source. It is the most comprehensive, rapid, specific, sensitive and quantitative microbial assay available. PhyloTech enables a new generation of applications to improve human health; assess environmental damages or the state of restoration; and identify the sources of food and water contamination.
International Neuroscience Network Foundation
Q2 Solutions| EA Genomics is performing genotyping and analysis services on clinical specimens for the International Neuroscience Network Foundation (INNF) as part of an ongoing, three-year project. This non-profit organization is dedicated to supporting cutting-edge research projects that address key areas in neuroscience. Of particular interest are interdisciplinary projects that combine new thinking and practices that could have dramatic impact on the development of new devices or therapeutics in the clinic. Areas of current interest are projects that combine engineering, microelectronics, computational sciences, and new concepts of brain dynamics. The INNF supports projects that cross the spectrum of research and development from animal studies to human clinical trials.
Immunological Genome Project
Q2 Solutions| EA Genomics is helping generate a complete microarray dissection of gene expression in the immune system of the mouse for the Immunological Genome Project, a consortium funded by the National Institutes of Health (NIH). The project will generate gene expression profiles and construct genetic regulatory works for all populations and subpopulations of immunological cells in the mouse. The goal is to develop a better understanding of immune-mediated diseases and responses in human beings.
Serious Adverse Events Consortium
Q2 Solutions| EA Genomics is serving as the exclusive phase one whole-genome genotyping laboratory for the Serious Adverse Events Consortium (SAEC). Initial studies for this non-profit consortium rely on Illumina’s Human 1M DNA Analysis BeadChip, which can interrogate more than one million genetic markers per sample. The SAEC is an international collaborative effort between the U.S. Food and Drug Administration (FDA), several pharmaceutical companies and academia. They are focused on identifying genetic biomarkers that may predict which individuals are at risk for drug-related adverse events.
Microarray Quality Control (MAQC) Project
Q2 Solutions | EA Genomics has participated as an official data analysis site in the first phase of the Federal Drug Administration’s MicroArray Quality Control (MAQC) Project, which was focused on reproducibility of results among seven microarray platforms and three other gene expression platforms. The project provided quality control tools to the microarray community to help it avoid procedural failures. It also seeks to develop guidelines for microarray data analysis by providing the public with large reference datasets along with readily accessible reference RNA samples. The project addressed the need to develop standards and quality measures prior to the successful and reliable use of microarray technology in clinical practice and regulatory decision making. The MAQC project involves six FDA Centers, major providers of microarray platforms and RNA samples, Environmental Protection Agency (EPA), National Institute of Standards and Technology (NIST), academic laboratories and other stakeholders. It will help improve microarray technology and foster its proper applications in discovery, development and review of FDA-regulated products.
Download MAQC publications from Nature Biotechnology website.
MAQC-II Clinical Working Group
Q2 Solutions| EA Genomics is participating in the second phase of the MAQC project. Dr. Wendell Jones, EA’s Vice President of Statistics and Bioinformatics, is co-leader of the clinical working group, in charge of validating gene expression signatures used as biomarkers in clinical studies.
U.S. EPA ToxCast™ Program
Q2 Solutions | EA Genomics provided gene expression and genotyping services for the U.S. Environmental Projection Agency’s ToxCast™ Program, using microarrays from Affymetrix and Illumina, as well as TaqMan PCR assays from Applied Biosystems. The ToxCast™ Program is managed by the National Center for Computational Toxicology of EPA. It is designed to provide an efficient, science-based prioritization of environmental chemicals for more detailed toxicological evaluations. ToxCast™ encompasses two phases over multiple years. The first proof-of-concept phase will involve over 300 chemicals, selected to include a diversity of chemical structures and toxicological profiles. The second phase will apply the approach to environmental chemicals of concern to the agency. A successful prioritization program will save significant dollars and reduce the number of animals required in identifying chemicals with the greatest potential toxicity.
Duke Institute for Genome Sciences & Policy
Q2 Solutions| EA Genomics is performing isolation and gene expression profiling services for the Duke Institute for Genome Sciences and Policy’s clinical trials. The Institute is dedicated to the study of life through scientific inquiry involving interdisciplinary research in genome sciences and policy. Expression Analysis is a passionate supporter and facilitator of Duke University research and scholarship that explore the impact of genome sciences on all aspects of life, human health and social policy.
Immune Tolerance Network
Q2 Solutions| EA Genomics is serving as the microarray core facility to support clinical trials for the Immune Tolerance Network (ITN). ITN is a non-profit, government-funded consortium of researchers working together to establish new treatments for diseases of the immune system. The ITN conducts clinical trials of specialized immune tolerance therapies to help find out how the body reacts to treatment, and to find better ways of measuring immune tolerance in the immune system. These studies focus in the following areas: