The Industry leader in multiplex immunoassay development and testing
DATA QUALITY
About Us
Rules-Based Medicine (RBM), a Q2 Solutions Company, brings more than 20 years of expertise in internally developing and manufacturing multiplex immunoassays validated to clinical laboratory standards for the Luminex xMAP® technology. In 2014, we began building ultrasensitive immunoassays on the Simoa™ platform to quantify protein biomarkers previously impossible to measure. The RBM platform appropriately combines Luminex and Simoa microsphere-based immunoassays with the precision and dependability of automated liquid handling systems, advanced quality monitoring, validated data reporting processes, and a highly trained and dedicated staff including project managers. RBM continues to provide the highest quality, cost-effective approach to measuring biomarkers from a variety of biological samples.
In 2021, Rules-Based Medicine became part of Q2 Solutions, a leading provider of drug discovery and global clinical trial laboratory services. Learn more at www.q2labsolutions.com.
Quality and Accreditation
Our policies are in compliance with the applicable portions of the following regulations:
We’ve designed our laboratory and component systems to deliver the highest quality data and to comply with the highest industry standards. RBM maintains a CLIA certificate of accreditation, performs internal audits, and participates in a proficiency-testing program comprised of external and internal assessments to ensure quality throughout the organization. We invite our customers to visit and audit our facility to review our high quality operations, procedures, and processes.
-
Good Laboratory Practices (21 CFR Part 58)
-
Quality System Regulation (21 CFR Part 820)
-
Electronic Signatures and Records (21 CFR Part 11)
-
Clinical Laboratory Improvement Amendments [CLIA] (42 CFR Part 493)
-
Good Clinical Practice (ICH E6)
Quality Policy
RBM is committed to the highest level of quality in our product. Quality and customer satisfaction shall underlie all of our efforts.
Certifications
RBM has earned CLIA licensure of accreditation from COLA, participates in external proficiency testing programs from CAP, and is capable of supporting Good Laboratory Practice (GLP) studies.
Employment
RBM’s CLIA certified biomarker testing laboratory, is located in Austin, TX.
