Asuragen Leadership
Offering the best data quality and turn-around time in such a rapidly evolving field
as gene expression analysis or miRNA profiling requires leadership. Gene expression
measurement platforms such as the ABI TaqMan® system and the Affymetrix®
GeneChip® system have existed for over a decade, but their transition
from research tools to clinical diagnostic devices has only recently begun. Because
methods are far from standardized, the industry is working together to define approaches,
characterize performance, and agree on methodologies to support strong basic and
clinical research.
Asuragen’s commitment, and the commitment of our scientific staff, is to participate
actively in the broader academic and regulatory communities for three purposes:
- To ensure the scientific conclusions drawn from any analysis are
based on data that is as accurate and reliable as the state-of-the-art technologies
can deliver
- To contribute our knowledge and experience for the benefit of
the field
- To ensure Asuragen’s methods and procedures comply with regulatory
requirements and guidelines, clinical practice, and widely accepted “best-practices”
True to these purposes, Asuragen and Asuragen employees have been active participants
in:
- MAQC, Phase I (completed)
- Asuragen acted as the only commercial Affymetrix test site, and was
actively involved in the bioinformatic analysis of the entire MAQC data set.
- MAQC, Phase II (ongoing)
- The overall objective of MAQC-II is to characterize approaches for
development and validation of classifiers utilizing DNA microarray data for the
purpose of diagnostic, prognostic, or therapeutic application. The FDA has solicited
existing and prospective gene expression datasets from microarray studies as well
as proposals to analyze these datasets in order to evaluate the impact of different
analysis protocols on the selection of genes and their associated signatures for
biomarker pattern development. The MAQC-II is comprised of five working groups:
clinical, pre-clinical, whole genome association, titration and regulatory biostatistics.
The regulatory biostatistics working group (RBWG) is led by co-chairs Tim Davison
and Gregory Campbell (Director, Division of Biostatistics CDRH) and Lakshmi Vishnuvajjala
(Chief, Diagnostic Devices Branch, Division of Biostatistics CDRH). The RBWG has
prepared a document outlining the standard operating procedures, methods and analysis
for MAQC-II in addition to focusing research on the identification of study designs
and performance measures for the evaluation of microarray technology and processes
for establishing choice of classifier algorithm, choice of validation strategy,
choice of normalization method, and handling of missing data. Asuragen will implement
and follow any regulations developed from this workgroup.
Asuragen Publications