Compliance
We, like many of our clients, work in regulated businesses where federal and international
laws and regulations govern our conduct. In addition, we abide by other international
standards because these have been shown to systematically improve quality. We take
these various aspects of compliance seriously at all levels within our organization,
and our clients can see it in our communications and deliverables.
cGLP:
The Code of Federal Regulations section 21 part 58 speaks to
any processes which generate data or information from your samples, ensuring that
data we deliver to a client are a true reflection of the results we obtain, and
therefore can be relied upon when making risk or safety assessments.
ISO-9001:2000
In addition, Asuragen has chosen to adopt the
ISO-9001:2000 standard to ensure that the business practices surrounding
our laboratory methods are constantly improving and quality-oriented.
CLIA
The objective of the CLIA program
is to ensure quality laboratory testing of human samples in clinical and diagnostic
applications. By complying with the CLIA regulations, Asuragen offers clients a
clear regulatory path to expedite the transition of a biomarker from "probable
valid" to "known valid" and broader use in clinical practice.
HIPAA
As a company who provides laboratory testing to ordering authorized healthcare providers,
Asuragen, Inc. is committed to protecting the privacy of patient personal information,
laboratory test results, and other protected health information. See our
HIPAA guidelines.
Various specific FDA Guidelines:
Interpretation of these laws and regulations can be complex, particularly in cutting-edge
areas like gene expression and miRNA profiling. We work with our clients to ensure
compliance with existing guildelines, but further by actively participating in studies
such as the MAQCII we can help ensure future studies are in line with future guidelines.
Learn more about Asuragen Leadership
Critical Path Initiative
As part of its
Critical Path Initiative, the FDA has identified the development of new
biomarkers as one of the key opportunities to increase efficiency, predictability,
and productivity in drug development. These new initiatives will accelerate the
approvals of novel drugs by integrating biomarkers and pharmacogenomic tests into
the clinical trial process. Subsequent utilization of companion diagnostics with
therapies will better match therapy to individuals. The Agency and its counterparts
in the major markets of the world are ready and willing to work with the increasing
number of drug companies that are generating pharmacogenomics data. They have issued
and refined guidance concerning pharmacogenomics data-submission, and encourage
closer interactions between academia, industry, and regulatory agencies.