What differentiates Rules-Based Medicine (RBM), a Q2 Solutions Company, from its competitors is that we have spent over 20 years internally developing and manufacturing multiplex immunoassays validated to clinical laboratory standards for the Luminex xMAP® technology. Since 2014, we have applied these skills to building ultrasensitive immunoassays on the Simoa™ platform to quantify protein biomarkers previously difficult or 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. Together these features set RBM apart from other biomarker testing laboratories by providing the highest quality, cost-effective approach to measuring biomarkers from a variety of biological samples.
Q2 Solutions is a leading global clinical trial laboratory services organization providing bioanalytical, genomics, vaccines, flow cytometry, anatomic pathology, immunoassay, companion diagnostics and central laboratory services with secure, enterprise-wide biospecimen and consent management solutions. At Q2 Solutions, our work is rooted in research, grounded in collaboration, and guided by our passion to turn the hope of patients and caregivers around the world into the help they need.
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)
RBM is committed to the highest level of quality in our product. Quality and customer satisfaction shall underlie all of our efforts.
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.
RBM’s CLIA certified biomarker testing laboratory, is located in Austin, TX.