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.
Asuragen’s Quality Management System (QMS) is certified to the ISO-13485:2016 standard to ensure that the practices surrounding our product development and on-market support are constantly improving and quality-oriented.
Asuragen’s Medical Device Single Audit Program (MDSAP) certification ensures that our quality management system satisfies the requirements of multiple regulatory jurisdictions. The scope of Asuragen’s MDSAP certification includes Australia, Brazil, Canada and the United States.
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. View our Licenses and Accreditations
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. HIPAA Privacy Notice
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 guidelines, 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.